supplementary online content · 1200 north elm street greensboro nc 27401 001066 california pacific...

37
© 2016 American Medical Association. All rights reserved.  Supplementary Online Content Vaduganathan M, Harrington RA, Stone GW, et al. Evaluation of ischemic and bleeding risks associated with 2 parenteral antiplatelet strategies comparing cangrelor with glycoprotein IIb/IIIa inhibitors: an exploratory analysis from the CHAMPION trials. JAMA Cardiol. Published online November 30, 2016. doi:10.1001/jamacardio.2016.4556 eAppendix. Centers Participating in the CHAMPION Trials eTable 1. Baseline Characteristics in the Propensity Score–Matched Cohorts of the CHAMPION PCI Trial eTable 2. Efficacy and Safety Endpoints at 48 Hours After Randomization in Original and Propensity Score–Matched Cohorts of the CHAMPION PCI Trial This supplementary material has been provided by the authors to give readers additional information about their work. Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

Upload: others

Post on 16-Apr-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

© 2016 American Medical Association. All rights reserved.  

Supplementary Online Content

Vaduganathan M, Harrington RA, Stone GW, et al. Evaluation of ischemic and bleeding risks associated with 2 parenteral antiplatelet strategies comparing cangrelor with glycoprotein IIb/IIIa inhibitors: an exploratory analysis from the CHAMPION trials. JAMA Cardiol. Published online November 30, 2016. doi:10.1001/jamacardio.2016.4556

eAppendix. Centers Participating in the CHAMPION Trials

eTable 1. Baseline Characteristics in the Propensity Score–Matched Cohorts of the CHAMPION PCI Trial

eTable 2. Efficacy and Safety Endpoints at 48 Hours After Randomization in Original and Propensity Score–Matched Cohorts of the CHAMPION PCI Trial

This supplementary material has been provided by the authors to give readers additional information about their work.

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

Page 2: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

001001 Medical Center, Beaver Kenneth House United States The Medical CenterBeaver Heritage Valley Health Systems

1000 Dutch Ridge RoadBeaver PA 15009

001002 University of Kentucky Charles Campbell United States x University of KentuckyOffice of Research Integrity 315 Kinkead

HallLexington KY 40536-0057

001003 Hamot Medical Center Timothy Trageser United States Hamot Medical Center Institutional Review Board 201 State Street Erie PA 16550

001004 Nasseff Heart Center Kenneth Baran United StatesAllina Institutional Review

BoardsUnited Hospital IRB 2925 Chicago Avenue Minneapolis MN 55407-1321

001005 Methodist Hospital Neal Kleiman United StatesThe Methodist Hospital

Research InstituteOffice of Grants and Contracts 6565 Fannin,

STB1-14Houston TX 77030

001006 Olathe Medical Center Brian Friedman United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001007 University Community Hospital Roberto Medina United StatesResearch Ethics Review

BoardUniversity Community Hospital 3100 E.

Fletcher AvenueTampa FL 33613

001008 St. Bernard's Medical Center Roger Hill United States St. Bernard's Medical Center 225 E. Jackson Jonesboro AR 72401

001009Hudson Valley Heart

Center/Vassar Brothers Medical Center

Zubair Jafar United StatesVassar Brothers Medical

Center Institutional Review Board

45 Reade Place Poughkeepsie NY 12601

001010 Heart Center, PC David Drenning United StatesHuntsville Hospital Institutional Review

Committee101 Sivley Road Huntsville AL 35801

001011Wellmont Holston Valley Medical

CenterHerbert Ladley United States

Wellmont Holston Valley Medical Center Institutional

Review Board130 W. Ravine Kingsport TN 37660

001013 Toledo Hospital Ahed Nahhas United StatesProMedica Health System

IRB

c/o Development, Grants & Research Administration Conrad Jobst Tower, Suite

900, 2142 N. Cove Blvd.Toledo OH 43606

001014Jim Moran Heart and Vascular

Research InstituteAlan Niederman United States Holy Cross Hospital IRB 4725 N. Federal Highway Fort Lauderdale FL 33308

001016 Dayton Heart Hospital Amit Goyal United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001018Asheville Cardiology Associates,

PAWilliam Abernethy United States

Institutional Review Committee

Office of Research Compliance and Administration 900 West Faris Road, CTC

2nd FloorGreenville SC 29605

001019 Rapides Regional Medical Center Naseem Jaffrani United StatesRapides Regional Medical

Center's IRB, Quality Management

211 Fourth Street P.O. Box 30101 Alexandria LA 71301

001020 Cape Cod Hospital Richard Zelman United States Cape Cod Healthcare IRB 14 Yellow Brick Road Hyannis MA 02601001021 Chattanooga Heart Institute Brian Negus United States Memorial Hospital IRB 2525 deSales Avenue Chattanooga TN 37404001022 Mercy Hospital Jose Marquez United States Mercy Hospital IRB 3663 South Miami Avenue Miami FL 33133

001023 University of California, San Diego Ehtisham Mahmud United StatesUCSD Human Research

Protection ProgramLa Jolla Village Professional Center 8950

Villa La Jolla, Suite A208San Diego CA 92037

001024 Harbor-UCLA Medical Center William French United States xJohn F. Wolf, MD Human

Subjects Committee

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center 1124 W.

Carson Street, N-14Torrance CA 90502

001025 Aultman Hospital John Paulowski United States Aultman Health FoundationHuman Research Review Board Office of

Research 2600 Sixth St., SWCanton OH 44710

001026 Pennsylvania Hospital Charles Pollack United States University of PennsylvaniaOffice of Regulatory Affairs 133 S. 36th

Street, Mezzanine LevelPhiladelphia PA 19104

001027 Lakeland Regional Medical Center Mark Mines United StatesLakeland Regional Medical

Center1324 Lakeland Hills Blvd. Lakeland FL 33805

001028 New Mexico Heart Institute Robert Federici United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001031 Baystate Medical Center Marc Schweiger United StatesJessica Young, JD Chair,

Institutional Review BoardBaystate Medical Center 759 Chestnut

StreetSpringfield MA 01199

001032Valley Baptist Medical Center

BrownsvilleKalim Habet United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001033 McAllen Heart Hospital Ofsman Quintana United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001034 Lynchburg General Hospital Thomas Nygaard United StatesCentra Health Inc.

Institutional Review BoardVirginia Baptist Hospital 3300 Rivermont

AvenueLynchburg VA 24503

001035 Doctors Hospital at Renaissance Carlos Mego United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001036Northern Indiana Research

AllianceSteve Orlow United States Lutheran Health Nework IRB 7950 W. Jefferson Blvd. Fort Wayne IN 46804

001037 Morton Plant Mease Health Care Douglas Spriggs United StatesBayCare Health Systems

Pasco-Pinellas IRB207 Jeffords Street MS #143 Clearwater FL 33756

The Medicines Company Confidential 1/8/2013 Page 1

Page 3320Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
eAppendix. Centers Participating in the CHAMPION Trials
cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 3: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

001038 Abbott Northwestern Hospital Ivan Chavez United StatesAllina Institutional Review

BoardsUnited Hospital IRB 2925 Chicago Avenue Minneapolis MN 55407-1321

001040 Rockingham Memorial Hospital Mark Warner United StatesRockingham Memorial

HospitalInstitutional Review Board 235 Cantrell

AvenueHarrisonburg VA 22801

001041 King's Daughters Medical Center Richard Paulus United StatesKing's DAughters Medical

Center IRB #12201 Lexington Avenue Ashlabd KY 41101

001043 St. John's Hospital David Cochran United StatesSt. John's Institutional

Review Board1235 E. Cherokee Street Springfield MO 65804

001044 Valley Hospital Carey Hirsch United States The Valley Hospital-IRB 223 N. Van Dien Avenue Ridgewood NJ 07450

001045 Winchester Medical Center Ajay Virmani United StatesWinchester Medical Center

IRB1840 Amherst Street Winchester VA 22601

001046Caritas St Elizabeths Medical

CenterPeter Soukas United States

Caritas St. Elizabeth's Medical Center

Research/Human Subjects Comm. 736 Cambridge St.

Boston MA 02135

001047Spartanburg Regional Medical

CenterNalin Srivastava United States

SRHS Institutional Review Board

101 East Wood Street Spartansburg SC 29303

001049 Rapid City Regional Hospital Norman Ferrier United States Regional Health IRB 353 Fairmont Blvd Rapid City SD 57701

001050 Mt. Sinai Medical Center Annapoorna Kini United StatesBiomedical Research

Alliance of New York, LLCInstitutional Review Board 225 Community

Drive, Suite 100Great Neck NY 11021

001051 Montefiore Medical Center Mark Greenberg United StatesBiomedical Research

Alliance of New York, LLCInstitutional Review Board 225 Community

Drive, Suite 100Great Neck NY 11021

001052Hospital of the University of

PennsylvaniaHoward Herrmann United States x University of Pennsylvania

Office of Regulatory Affairs 133 S. 36th Street, Mezzanine Level

Philadelphia PA 19104

001053Ralph H Johnson VA Medical

CenterValerian Fernandes United States x

Office of Research, Integrity & Risk Protection,

Institutional Review Board

Medical University of South Carolina 165 Cannon Street, PO Box 250587

Charleston SC 29425

001056 North Mississippi Medical Center Barry Bertolet United StatesNorth Missisippi Health

Services Institutional Review Board

830 South Gloster Street Tupelo MS 38801

001057 Washington Hospital Center Ron Waksman United States xMedStar Research Institute, Institutional Review Board

6495 New Hampshire Avenue, Suite 201 Hyattsville MD 20783

001059Greenville Hospital System University Medical Center

Joseph Henderson United StatesInstitutional Review

Committee

Office of Research Compliance and Administration 900 West Faris Road, CTC

2nd FloorGreenville SC 29605

001060Western Medical Center Santa

AnaHarinder Gogia United States

Western Medical Center Santa Ana IRB

1001 N. Tustin Ave Santa Ana CA 92705

001061 Tomball Regional Hospital Maged Amine United States xTomball Regional Hospital

IRB605 Holderrieth Drive Tomball TX 77375

001062 St. Joseph Medical Center Kourosh Mastali United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001064 Moses H. Cone Memorial Hospital Thomas Stuckey United StatesMoses H. Cone Memorial

Hospital Insitutional Review Board

1200 North Elm Street Greensboro NC 27401

001066 California Pacific Medical Center Peter Hui United StatesCalifornia Pacific Medical

Center, Institutional Review Board

2200 Webster Street, 5th Floor San Francisco CA 94115

001068 St. Vincent's Hospital Luigi Pacifico United States

Saint Vincent Hospital/ Fallon Clinic/ Fallon

Community Health Plan, Institutional Review Board

Worcester Medical Center 123 Summer Street

Worcester MA 01608

001069Providence St. Vincent Medical

CenterTodd Caulfield United States Providence Health System

Institutional Review Board 5251 NE Glisan, Bldg. A 3rd Floor

Portland OR 97213

001070St. Mary's Medical Center, Duluth

ClinicWilson Ginete United States

St. Mary's/Duluth Clinic Health System

Institutional Review Board 400 East Third Street

Duluth MN 55805

001071Piedmont Hospital / Fuqua Heart

Center of AtlantaWilliam Ballard United States Piedmont Hospital

Institutional Review Board 1968 Peachtree Road NW

Atlanta GA 30309

001072 Presbyterian Hospital Robert Iwaoka United States Presbyterian Healthcare IRB 200 Hawthorne Lane PO Box 33549 Charlotte NC 28233-3549

001073 St. Francis Hospital Joseph Stella United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001074University of Alabama at

BirminghamVijay Misra United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001075 Gaston Memorial Hospital Costa Andreou United StatesCaroMont Health Insitutional

Review Board2525 Court Drive, PO Box 1747 Gastonia NC 28053

001076 Emory Crawford Long Hospital Michele Voeltz United StatesEmory University,

Institutional Review Board1599 Clifton Road, 5th Floor Atlanta GA 30322

The Medicines Company Confidential 1/8/2013 Page 2

Page 3321Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 4: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

001077 Tallahassee Memorial Healthcare Wayne Batchelor United StatesTallahassee Memorial,

Institutional Review Board1300 Miccosukee Road Tallahassee FL 32308

001078St. Vincent Catholic Medical

CenterCezar Staniloae United States

Integrated Scientific & Ethical Review Board

170 West 12th Street Staff House New York NY 10011

001080 University Hospital Of Cleveland Daniel Simon United StatesUniversity Hospitals of

ClevelandOffice of Institutional Review 11100 Euclid

AveCleveland OH 44106

001083 Cooper University Hospital Sanford Gips United States Cooper Univerisity Hospital 1 Cooper Plaza Camden NJ 08103

001084Our Lady of Lourdes Medical

CenterJeffrey Kramer United States

Our Lady of Lourdes Medical Center

1600 Haddon Avenue Camden NJ 08103

001085 Sentara Norfolk General Hospital Paul Mahoney United StatesChesapeake Research

Review, Inc7063 Columbia Gateway Drive Ste 110 Columbia MD 21046

001086 Union Memorial Hospital John Wang United StatesMedStar Research Institute, Institutional Review Board

6495 New Hampshire Avenue, Suite 201 Hyattsville MD 20783

001087University of Vermont -Fletcher

Allen Health CCUProspero Gogo United States x

University of Vermont-Research Protections Office

Office of Sponsored Programs 245 South Park, Suite 900

Colchester VT 05446

001088 Scottsdale Healthcare - Osborne David Rizik United States Scottsdale Healthcare IRB 9003 E. Shea Blvd Scottsdale AZ 85260001089 Scottsdale Healthcare - Shea David Rizik United States Scottsdale Healthcare IRB 9003 E. Shea Blvd Scottsdale AZ 85260

001090Long Beach Memorial Medical

CenterRex Winters United States

Long Beach Memorial Medical Center

Research Administration 2801 Atlntic Avenue

Long Beach CA 90801

001091 McKay-Dee Hospital Center Garry MacKenzie United States McKay-Dee Hospital CenterInstitutional Review Board 4401 Harrison

Blvd.Ogden UT

Ogden, UT 84403

001093 Ochsner Clinic Foundation Stephen Jenkins United StatesOchsner Institutional Review

Board1514 Jefferson Highway New Orleans LA 70121

001094 Scripps Green Hospital Paul Teirstein United States xScripps Health Green

Hospital IRB #2 (Human Subjects Committee)

11025 North Torrey Pines Road Suite 200 La Jolla CA 92037

001095 Deaconess Medical Center Pierre Leimgruber United States xInstitutional Review Board -

Spokane310 N. Riverpoint Blvd. P.O. Box 1495 Spokane WA 99210-1495

001097University of Tennesee Medical

CenterJ. Christopher Scott United States

Crescent City Institutional Review Board

2820 Canal Street New Orleans LA 70119

001099 Providence Alaska Medical Center Seth Krauss United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001100High Point Regional Health

SystemSteven Rohrbeck United States x

High Point Regional Health System

Institutional Review Board P.O. Box HP-5 High Point NCHigh Point, NC

27261

001101Pinnacle Health @ Harrisburg

HospitalRobert Martin United States PinnacleHealth @ Polyclinic 2501 North Third Street 709 Landis Building Harrisburg PA 17110

001103Houston Northwest Medical

CenterGustavo Griecio United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001105 Western PA HospitalVenkatraman

SrinivasanUnited States

The Western Pennsylvania Hospital

The Institutional Review Board (IRB) 4800 Friendship Avenue

Pittsburg PA 15224

001109 Northern Michigan Hospital Louis Cannon United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001110 Elkhart General Hospital Don Westerhausen United StatesElkhart General Healthcare

System600 East Blvd. Elkhart IN 46514

001112 Mayo Clinic Hospital - Arizona David Fortuin United StatesMayo Foundation

Institutional Review Board200 First SW Rochester MN 55905

001113 John Hopkins Hospital Steven Schulman United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001114 Ingham Regional Medical Center Joel Cohn United StatesIngham Regional Medical

Center IRB401 W. Greenlawn Lansing MI 48910

001115 Anderson Area Medical Center Brent McLaurin United States Andmed Health IRB 800 North Fant Street Anderson SC 29621

001118University of OK Health Sciences

CenterJorge Saucedo United States x

OUHSC Institutional Review Board

1000 Stanton L Young Blvd, LIB 176 Oklahoma City OK 73190

001119 North Austin Medical Center Robert Wozniak United StatesAustin Multi-Institutional

Review BoardPO Box 27782 Austin TX 78755-7782

001120 Care Group Jack Hall United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001122 Clarian Health Partners Jeffrey Breall United StatesClarian Health

Partners/Methodist Hospital Institutional Review Board

I-65 @21st St PO Box 345 Indianapolis IN 46206

001123 Winthrop University Hosp Kevin Marzo United States Winthrop University HospitalInstitutional Review Board 222 Station

Plaza, Suite 521Mineola NY 11501

001126 Morton Plant Hospital Merrill Krolick United StatesBayCare Health Systems

Pasco-Pinellas IRB207 Jeffords Street MS #143 Clearwater FL 33756

The Medicines Company Confidential 1/8/2013 Page 3

Page 3322Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 5: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

001127University of Virginia Health

SystemLawrence Gimple United States

University of Virginia Institutional Review Board

for Health Sciences Research

One Morton Drive Suite 400, Box 5 Charlottesville VA 22903

001129 Kansas City Heart Foundation Eric Hockstad United StatesPatient Advocacy Council,

Inc.601 El Air Blvd., Suite 315 Mobile AL 36606

001131 Florida Hospital Arsenio Rodriguez United StatesFlorida Hospital Institutional

Review Board212 E. Winter Park Street Orlando FL 32804

001132 Jesse Brown VAMC Adhir Shroff United StatesOffice for the Protection of

Research Subjects1737 W. Pollk Street, M/C 672 203

Administrative Office BuildingChicago IL 60612

001133University of Illinois at Chicago

Medical CenterAdhir Shroff United States

Office for the Protection of Research Subjects

1737 W. Pollk Street, M/C 672 203 Administrative Office Building

Chicago IL 60612

001134 NYU Medical Center Michael Attubato United States NYU School of Medicine IRB 550 First Avenue #VET, 10th Flr, West Wing New York NY 10016

001136Baptist Cardiac and Vascular

InstituteRamon Quesada United States

Baptist Health South Florida, Institutional Review Board

8900 North Kendall Drive Miami FL 33176-2609

001137Northwest Texas Healthcare

SystemErnesto Rivera United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001139 Christ Hospital Dean Kereiakes United StatesThe Christ Hospital

Institutional Review Board2139 Auburn Avenue Cincinnati OH 45219

001140 Cleveland Clinic Foundation Russell Raymond United StatesThe Cleveland Clinic

FoundationInstitutional Review Board Desk Wb-2, 9500

Euclid Ave.Cleveland OH 44195

001142 Hope Heart Institute Thomas Amidon United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001143Stanford University Medical

CenterDavid Lee United States

Stanford University, Medical Human Subjects Panel

Adminitrative Panels Office 1215 Welch Road, Mod. A

Stanford, CA 94305-5401

001144Saint Joseph’s Hospital of Atlanta,

Inc. Saint Joseph’s Research Institute

Spencer King,III United StatesSaint Joseph's Hospital of

Atlanta Institutional Review Board

5673 Peachtree Dunwoody Road Suite 650 Atlanta GA 30342

001145 Emory University Hospital John Douglas United StatesEmory University,

Institutional Review Board1599 Clifton Road, 5th Floor Atlanta GA 30322

001148 West Virginia University Abnash Jain United States West Virginia University, IRB 886 Chestnut Ridge Road Morgantown WV 26506-6845

001149 Lehigh Valley Heart Specialists Patrick Kleaveland United StatesResearch Participant

Protection OfficeLehigh Valley Hospital 17th and Chew

Streets, 6T31Allentown PA 18105

001150 Bridgeport Hospital Mitchell Dreisman United States Bridgeport Hospital, Institutional Review Board 267 Grant Street Bridgeport CT 06610

001151 Wisconsin Heart Hospital Krishna Kumar United StatesWheaton Franciscan

Healthcare IRB400 W. River Woods Parkway Milwaukee WI 53212

001153 Carolina Medical Center, Charlotte Glen Kowalchuk United States Copernicus Group IRB 118 MacKenan Drive Suite 400 Cary NC 27511

001154 Forsyth Medical Center Behzad Taghizadeh United StatesForsyth Medical Center,

Institutional Review Board3333 Silas Creek Parkway Winston-Salem NC 27103

001156 Elmhurst Memorial Hospital Lawrence Barr United StatesElmhurst Institutional

Review Board200 Berteau Avenue Elmhurst IL 60126

001157 Northwestern University Keith Benzuly United StatesNorthwestern Institutional

Review BoardRubloff Hall, 7th Floor 750 N. Lake Shore

DriveChicago IL 60611

001159 University Hospital Tarek Helmy United StatesInstitutional Review Board

Medical Center University of Cincinnati

P.O. Box 670567 G-08 Wherry Hall, ML 0567, Eden Avenue and Albert Sabin Way

Cincinnati OH 45267-0567

001162Beth Israel Deaconess Medical

CenterDuane Pinto United States

Beth Israel Deaconess Medical Center

Committee on Clinical Investigation 330 Brookline Ave

Boston MA 02215

001166 Santa Barbara Cottage Hospital Joseph Aragon United StatesCottage Health System

Institutional Review BoardPueblo at Bath Street Santa Barbara CA 93105

001168 UC Davis Medical Center Reginald Low United StatesIRB Administration, UC Davis Medical Center

2921 Stockton Blvd. CTSC Building, Suite 1400, Room 1429

Sacramento CA 95817

001170Columbia University Medical

CenterLeRoy Rabbani United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001174 University of Iowa Hospital Phillip Horwitz United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001178Upper Michigan Cardiovascular Associates (Marquette General

Health System)Thomas LeGalley United States

Marquette General Health System

Institutional Review Board 420 W. Magnetic Marquette MI 49855

The Medicines Company Confidential 1/8/2013 Page 4

Page 3323Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 6: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

001180University of Florida Health

Science CenterDominick Angiolillo United States x WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001186Central Arkansas Veterans

Healthcare System (CAVHS)Rajesh Sachdeva United States

University of Arkansas for Medical Sciences

Institutional Review Board 4301 West Markham

Little Rock AR 72205

001188 Suburban Hospital Kenneth Kent United States Suburban Hospital IRB 8600 Old Georgetown Road Bethesda MD 20814

001192 Stony Brook University Hospital Luis Gruberg United StatesChesapeake Research

Review, Inc7063 Columbia Gateway Drive Ste 110 Columbia MD 21046

001200University of Chicago Medical

CenterJohn Lopez United States

University of Chicago, Institutional Review Board

McGiffert Hall, 2nd floor 5751 S. Woodlawn Avenue

Chicago IL 60637

001212 Christiana Care Health Services Michael Stillabower United StatesChristiana Care Health

System, Institutional Review Board

501 West 14th Street Wilmington DE 19889-1668

001213 Metro Health Medical Center Kathleen Quealy United States MetroHealth IRBMetroHealth Medical Center 2500

MetroHealth DriveCleveland OH 44109

001215Washington University/Barnes-

Jewish HospitalRichard Bach United States Washington University

Human Research Protection Office Campus Box 8089, 660 S. Euclid

St. Louis MOSt. Louis, MO

63110

001216 Lakeland Hospital St. Joseph Thomas Pow United StatesLakeland Hospital IRB#1 at

St. Joseph1234 Napier Ave. St. Joseph MI 49085

001217 DMH Regional Medical CenterCharles

O'ShaughnessyUnited States

EMH Regional Medical Center Institutional Review

Board630 East River Street Elyria OH 44035

001223 Centennial Medical Center Steven Manoukian United States x WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001225New York Presbyterian Hospital-

CornellChiu Wong United States

Weil Medical College of Cornell University

Institutional Review Board

University Institutional Review Board 425 East 61st Street, Suite DV-301

New York NY 10065

001229 St. Francis Hospital SaeedR Shaikh United StatesSt. Francis Hospital and

Health Centers Institutional Review Board

1600 Albany Street Beech Grove IN 46107

001230 Wellstar Kennestone Hospital Arthur Reitman United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

001231 Scott and White Hospital Mark Lawrence United StatesScott & White Institutional

Review Board2401 31st Street Temple TX 76508

001242 St. Luke's-Roosevelt Hospital Mun K. Hong United StatesInstitutional Review Board Institute of Health Sciences

432 West 58th St #207 New York NY 10019

002003 Southlake Regional Health Centre Warren Cantor CanadaOptimum Clinical Research

Inc.231 King St East Oshawa Ontario L1H 1C5

002006 QEII Health Sciences Centre Lawrence Title CanadaResearch Ethics Board, Room 118, Centre for

Clinical Research5790 University Avenue Halifax

Nova Scotia

B3H 1V7

002012 Royal Alexandria Hospital William Kin Kong CanadaHealth Research Ethics

Board213 Heritage Medical Research Center,

University of AlbertaEdmonton Alberta T6G 2S2

002017 Trillium Health Centre Charles Lazzam CanadaOptimum Clinical Research

Inc.231 King St East Oshawa Ontario L1H 1C5

002025 Hôpital Notre-Dame du CHUM Francois Reeves CanadaComite d'ethique de la recherche du CHUM

Edifice Cooper, Mezzanine 2 3981 boul. St-Laurent

Montreal Quebec H2W 1Y5

002031 London Health Sciences Centre Jaffer Syed Canada

Research Ethics Board for the Revies of Health

Sciences Research Involving Human Subjects

Dental Science Building Room 00049 London Ontario N6A 5C1

002032 Montreal Heart InstituteJean-Francois

TanguayCanada

Ethics Committee, Montreal Heart Institute

Research Center, S-3500, 500 Belander Street

Montreal Quebec H1T 1C8

034001 Hospital Meixoeiro Andres Iniguez SpainHospital Universitario Puerta

de HierroArea VI C/ San Martin de Porres, 4 Madrid 28035

034002 Hospital Virgen de Las Nieves Rafael Melgares SpainHospital Universitario Puerta

de HierroArea VI C/ San Martin de Porres, 4 Madrid 28035

034004Hospital Puerta de Hierro -

MajadahondaFrancisco Goicolea Spain

Hospital Universitario Puerta de Hierro

Area VI C/ San Martin de Porres, 4 Madrid 28035

034005 Hospital del Mar Jordi Bruguera SpainHospital Universitario Puerta

de HierroArea VI C/ San Martin de Porres, 4 Madrid 28035

034006 Hospital Virgen de La Victoria Jose Hernandez SpainHospital Universitario Puerta

de HierroArea VI C/ San Martin de Porres, 4 Madrid 28035

034007Hospital Universitario Marques de

ValdecillaJavier Zueco Spain Ethic Committee: Area VI San Martin Porres, 4 Madrid 28035

The Medicines Company Confidential 1/8/2013 Page 5

Page 3324Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 7: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

039002 Azienda Ospedaliera di Legnano Stefano De Servi ItalyComitato Etico dell'Azienda Ospedaliera Ospedale Civile

di LegnanoVia Candiani, 2 Legnano MI 20025

039004 Ospedali Riuniti di Bergamo Giuseppe Musumeci ItalyComitato BioEtico

dell'Azienda Ospedall Riuniti di Bergamo

Largo Barozzi, 1 Bergamo 24128

039005 Azienda Ospedaliera di Parma Alberto Menozzi ItalyComitato Etico Unico Per La

Provincia Di ParmaVia Gramsci, 14 Parma 43100

039006 Ospedale della Misericordia Bernardo Cortese Italy Comitato Etico LocaleComitato per la Sperimentazione dei

Farmaci c/o UO Farmaceutica Territoriale Via Genova 6/d

Grosseto 58100

039007 Centro Cardiologico Monzino Giancarlo Marenzi Italy

Comitato Etico, Centro Cardiologico Monzino, Institute of Cardiology,

University of Milan,

Via Parea 4 Milano 20138

039008Ospedale Clinicizzato SS

AnnunziataRaffaele De Caterina Italy

Comitato di Etica per la Ricerca Biomedica

c/o Presidenza della Facolta di Medicina e Chirurgia Universita degil Studi "G.

d'Annunzio", Nuovo Polo Didattico, Via dei Vestini

Chieti Scalo CH 66013

043001 Wilhelminenspital der Stadt Wien Kurt Huber AustriaEthik Kommission der Stadt

WienDr. Thomas Klestil Platz 8 Vienna A-1030

043002 Krankenhaus der Stade Linz Franz Leisch AustriaEthik Kommission der Stadt

WienNeutorgasse 15 Vienna A-1010

043003St. Johanns Spital, Landesklinik

fur Innere MedizinJohann Altenberger Austria

MA 15-Gesundheitsdienst de Stadt Wien

Dr. Thomas Klestil Platz 8 Vienna A-1030

043004 Hanusch Krankenhaus Georg Gaul AustriaMA 15-Gesundheitsdienst de

Stadt WienDr. Thomas Klestil Platz 8 Vienna A-1030

043005AKH der Stadt Wien,

Universitatsklinik fur Innere Medizin II

Thomas Neunteufl AustriaMA 15-Gesundheitsdienst de

Stadt WienDr. Thomas Klestil Platz 8 Vienna A-1030

043007 Rudolfstiftung Franz Weidinger AustriaEthik Kommission der Stadt

WienTownTown, Thomas Klestil-Platz 8 Vienna A-1030

043008 LKH Graz West Herwig Schluchleinz AustriaEthik Kommission der Stadt

WienTownTown, Thomas Klestil-Platz 8 Vienna A-1030

043009 SMZ Ost Heinrich Weber AustriaEthik Kommission der Stadt

WienTownTown, Thomas Klestil-Platz 8 Vienna A-1030

043010 LKH Feldkirch Werner Benzer AustriaEthikkomission der Stadt

WienNeutorgasse 15 Vienna A-1010

048003Samodzielny Publiczny Szpital

Kliniczny Akademii Medycznej w Bialymstoku

Slawomir Dobrzycki PolandKomisja Bioetyczna przy

Slaskiej Adademii w Medycznej

ul. Warszawaska 14 Katowice 40-006

048003Samodzielny Publiczny Szpital

Kliniczny Akademii Medycznej w Bialymstoku

Slawomir Dobrzycki PolandKomisja Bioetyczna przy Adademii w Bialymstoku

ul. Kilinskiego 1 Bialystok 15-230

048004Szpital Specjalistczny Sw.

Wojciecha-AdalbertaWaldemar Domiak Poland

Komisja Bioetyczna Slaskiego Uniwersytetu

Medycznego w Katowicachul. Warszawaska 14 Katowice 40-006

048005SPZOZ Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny II

Kliniki KardiologiiDariusz Dudek Poland

Komisja Bioetyczna Slaskiego Uniwersytetu

Medycznego w Katowicachul. Poniatowskiego 15. Katowice 40-055

048006SPSK Nr 7 Slaskiego Uniwersytetu

Medycznego w KatowicachZbigniew Gasior Poland

Komisja Bioetyczna Slaskiego Uniwersytetu

Medycznego w Katowicachul. Poniatowskiego 15. Katowice 40-055

048008Wielospecjalistyczny Szpital

Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Nowej Soli

Jaroslaw Hiczkiewicz PolandKomisja Bioetyczna przy

Slaskiej Akademii Medycznejul. Warszawaska 14 Katowice 40-006

048008Wielospecjalistyczny Szpital

Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Nowej Soli

Jaroslaw Hiczkiewicz PolandKomisja Bioetyczna przy

Okregowej Izby Lekarskiej w Zielonej Gorze

ul. Braniborska 17 Zielona Gora 65-273

048009Samodzielny Publiczny Szpital Kliniczny Nr 2 w Szczencinie

Zdzislawa Komacewicz-Jach

PolandKomisja Bioetyczna

Slaskiego Uniwersytetu Meducznego w Katowicach

ul. Warszawaska 14 Katowice 40-006

The Medicines Company Confidential 1/8/2013 Page 6

Page 3325Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 8: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

048010 Wojskowy Instytut Medyczny Leszek Kubik PolandKomisja Bioetyczna

Slaskiego Uniwersytetu Meducznego w Katowicach

ul. Warszawaska 14 Katowice 40-006

048011

Szpital Wojewodzki Samodzielny Publiczny Zaklad Opieki Zdrowotnej im. Karola

Marcinkiowskiego

Krzysztof Kuc PolandKomisja Bioetyczna

Slaskiego Uniwersytetu Meducznego w Katowicach

ul. Warszawaska 14 Katowice 40-006

048012 Szpital Wojewodzki nr 2 Jerzy Kuzniar PolandKomisja Bioetyczna

Slaskiego Uniwersytetu Meducznego w Katowicach

ul. Warszawaska 14 Katowice 40-006

048013SPSK Nr 1 we Wroclawiu , Katedra i Klinika Kardiologii

Walentyna Mazurek PolandKomisja Bioetyczna

Slaskiego Uniwersytetu Medycznego w Katowicach

ul. Poniatowskiego 15. Katowice 40-055

048014Wojewodzki Szpital Zespolony w

ElblaguJakub Ostrowski Poland

Komisja Bioetyczna Slaskiego Uniwersytetu

Meducznego w Katowicachul. Warszawaska 14 Katowice 40-006

048015ZOZ Poznan-Stare Miasto, Szpital Miejski im. J. Strusia w Poznaniu

Janusz Rzezniczak PolandKomisja Bioetyczna przy Slaskim Uniwersytecie

Medycznym w Katowicachul. Warszawska 14, Katowice 40-006

048016Samodzielny Publiczny Szpital

Kliniczny Nr 7 Slaskiej Akademii Medycznej w Katowicach

Michal Tendera PolandKomisja Bioetyczna

Slaskiego Uniwersytetu Meducznego w Katowicach

ul. Warszawaska 14 Katowice 40-006

048017Wojewodzki Szpital w Przemyslu,

Pracownia HemodynamikiAndrzej Wisniewski Poland

Komisja Bioetyczna Slaskiego Uniwersytetu

Medycznego w Medycznegoul. Warszawska 14 Katowice 40-006

048018Szpital Wojewodzki im. Miko?aja Kopernika w Koszalinie, Oddzial

KardiologiiElzbieta Zinka Poland

Komisja Bioetyczna Slaskiego Uniwersytetu

Medycznego w Katowicachul. Poniatowskiego 15. Katowice 40-055

048019Krakowski Szpital Specjalistyczny

im. Jana Pawła II w KrakowieKrzysztof Zmudka Poland

Komisja Bioetyczna przy Slaskim Uniwersytecie

Medycznym w Katowicachul. Warszawska 14, Katowice 40-006

048020SPZOZ Uniwersytecki Szpital

Kliniczny Nr 3 im. Dr. Seweryna Sterlinga Uniwersytetu

Maciej Kosmider PolandKomisja Bioetyczna

Slaskiego Uniwersytetu Medycznego w Katowicach

ul. Poniatowskiego 15. Katowice 40-055

049001 St Johannes Hospital Dortmund Hubertus Heuer Germany Ethik-Kommission derUniversitat Witten/Herdecke Alfred-

Herrhausen-Str.50Witten D-58448

049003Asklepios Klinik Innere Medizin

KardiologieHans-Georg Olbrich Germany

Landesesaerztekammer Hessen Ethikkommission

Im Vogelsgesang 3Frankfurt am

Main60488

049004Universitaet Mainz / Medizinische

Klinik IISabine Genth-Zotz Germany Ethik-Kommission der

Universitat Witten/Herdecke Alfred-Herrhausen-Str.50

Witten D-58448

049005 Herzzentrum Leipzig Sven Moebius-Winkler Germany Ethik-Kommission derUniversitat Witten/Herdecke Alfred-

Herrhausen-Str.50Witten D-58448

049007Klinikum Kroellwitz / Innere

MedizinMichael Buerke Germany Ethik-Kommission der

Universitat Witten/Herdecke Alfred-Herrhausen-Str.50

Witten D-58448

049008Vivantes Klinikum im

FriedrichshainStefan Hoffmann Germany Ethik-Kommission der

Universitat Witten/Herdecke Alfred-Herrhausen-Str.50

Witten D-58448

049009Universitaetsklinikum Schleswig-

HolsteinPeter Radke Germany Ethik-Kommission der

Universitat Witten/Herdecke Alfred-Herrhausen-Str.50

Witten D-58448

049010 Kerckhoff Klinik GmbH Helge Moellmann Germany Ethik-Kommission derUniversitat Witten/Herdecke Alfred-

Herrhausen-Str.50Witten D-58448

049012Medizinische Universitaetsklinik u.

PoliklinikHugo Katus Germany Ethik-Kommission der

Universitat Witten/Herdecke Alfred-Herrhausen-Str.50

Witten D-58448

049013 DRK Krankenhaus KoepenickHans-Friedrich

VoehringerGermany Ethik-Kommission der

Universitat Witten/Herdecke Alfred-Herrhausen-Str.50

Witten D-58448

049014Klinik und Poliklinik für Innere

Medizin II Klinikum der Universität Regensburg

Christian Hengstenberg

Germany Ethik-Kommission derUniversitat Witten/Herdecke Alfred-

Herrhausen-Str.50Witten D-58448

049015Klinikum der Universitaet

MuenchenVolker Klauss Germany Ethik-Kommission der

Universitat Witten/Herdecke Alfred-Herrhausen-Str.50

Witten D-58448

049016 Klinikum Coburg gGmbH Johannes Brachmann Germany Ethik-Kommission derUniversitat Witten/Herdecke Alfred-

Herrhausen-Str.50Witten D-58448

The Medicines Company Confidential 1/8/2013 Page 7

Page 3326Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 9: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

054002Instituto Cardiovascular de

Buenos AiresFernando Cura Argentina

Comite de Etica Independiente - Instituto Cardiovascular de Buenos

Aires

Blanco Encalada 1525 Buenos Aires C1428DCO

054008 Hospital Privado de Córdoba Miguel Ballarino Argentina Comite de Revision InternaNaciones Unidas 346 - B Parque Velez

Sarsfield Cordoba X5016KEH

054009Instituto Cardiovascular de

RosarioAnibal Damonte Argentina

Comite de Etica Dr. Virgillo G. Foglia

Tucuman 335 7 D Buenos Aires 1049

054010 Hospital Español Diego Grinfeld ArgentinaComite de Etica Dr. Virgillo

G. FogliaTucuman 335 7 D Buenos Aires 1049

054011 Hospital Italiano Regional del Sur Carlos Alvarez ArgentinaComite Hospitalario de Etica, Hospital Italiano

Regional del SurNecochea 675 Buenos Aires

Bahia Blanca

B8001HXM

054012 Sanatorio Modelo Quilmes Alberto Fernandez ArgentinaComite de Etica

Independiente en Investigacion Clinica

Larrea 1381 3 A Buenos AiresCapital Federal

C1117ABK

055001 Hospital Evangélico de Curitiba Paulo Rossi BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055001 Hospital Evangélico de Curitiba Paulo Rossi Brazil

Comite de Etica em Pesquisa da Sociedade

Evangelica Beneficente de CuritibaRua Padre Anchieta

2770

- Curitiba Parana -

055002 Casa de Saúde Santa Marcelina Breno Almeida BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055002 Casa de Saúde Santa Marcelina Breno Almeida BrazilComite de Etica em

Pesquisa - Casa de saude Santa Marcelina

Rua Santa Marcelina n 91 - Bloco A - Itaquera

Sao Paulo 08270-070

055003 Fundação Bahiana de Cardiologia Antonio Godinho BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055003 Fundação Bahiana de Cardiologia Antonio Godinho Brazil

Comite de Etica em Pesquisa em Seres

Humanos da Maternidade Climerio de Oliveira/UFBA

Rua Padre Feijo, 240, Amb. Magalhaes Neto, PPgMS, 3 andar

Salvador - BA -

055004 Hospital Espanhol Fabio Vilas-Boas BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055004 Hospital Espanhol Fabio Vilas-Boas Brazil

Comite de Etica em Pesquisa da Real Sociedade

espanhola de Beneficiencia/Hospital

Espanhol

Av. Sete de Setembro, 4161, Barra Salvador - BA 41148-900

055005 Hospital do Coração do BrasilLuciano Liberato de

SousaBrazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055005 Hospital do Coração do BrasilLuciano Liberato de

SousaBrazil

Comite de etica e Pesquisa: Hospital das Forcas

Armadas/HFA

HFA - Estrada Parque Contorno do Bosque s/h

Cruzeiro Nova 70558-900

055006Instituto de Cardiologia do

Espírito SantoRenato Serpa Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055006Instituto de Cardiologia do

Espírito SantoRenato Serpa Brazil

Comite de Etica em Pesquisa em Seres Humanos do Centro

Integrado de Atencao e Saude - CIAS

av. Leitao da Silva, 2311 - Otarare Vitoria - ES 29047 - 575

055007 Hospital Lucio Rebelo Jose Jatene BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

The Medicines Company Confidential 1/8/2013 Page 8

Page 3327Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 10: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

055007 Hospital Lucio Rebelo Jose Jatene BrazilComite de Etica em

Pesquisa do Hospital de urgencias de Goiania

Av. 31 de <arcp. Esq/ cp, 5 radoa;. s/n. Goiania - GO Cep: 74820-200

055008 Hospital Geral de Goiania Vinicius Vaz BrazilComite de Etica e Pesquisa Humana e Animal (CEPHA)

Av Anhanguera n4379 Setor Oeste Goiania - GO 74043-011

055010Santa Casa de Misericórdia de

Belo HorizonteGilmar Reis Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055010Santa Casa de Misericórdia de

Belo HorizonteGilmar Reis Brazil

Comite de Etica em Pesquisa da Santa Casa de

Misericordia de Belo Horizonte

Av. Francisco Salles 1.111 - 9 Andar Belo Horizonte MG 30150-221

055011 Hospital Felicio Rocho Jamil Saad BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055011 Hospital Felicio Rocho Jamil Saad Brazil

Comite de Etica em Pesquisa em Seres

Humanos do Hospital Felicio Rocho/MG

Av. do Contorno, 9530 Barro Preto Cep:30110-908

055012 Hospital Madre Teresa Marcos Marino BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055012 Hospital Madre Teresa Marcos Marino BrazilComite de Etica em

Pesquisa do Hopital Madre Teresa

Av. Raja Gabaglia, GutierrezBelo

Horizonte/MG30380.090

055013Instituto do Coração do Triângulo

MineiroRoberto Botelho Brazil

Comite de Etica em Pesquisa da Santa Casa de

Misericordia de Belo Horizonte

Av. Francisco Salles 1.111 - 9 Andar Belo Horizonte MG 30150-221

055013Instituto do Coração do Triângulo

MineiroRoberto Botelho Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055014 Hospital Cardiológico Constantini Costantino Costantini BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055014 Hospital Cardiológico Constantini Costantino Costantini Brazil

Comite de Etica em Pesquisa da Liga

Paranaense de Combate ao Cancer/Hospital Erasto

Gaertner

Rua Dr. Ovande do Amaral 201 - Bairro Jardim das Americas

Curitiba-PR 81520-060

055015Hospital de Caridade Santa Casa

de Misericórdia de CuritibaRicardo Wang Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055015Hospital de Caridade Santa Casa

de Misericórdia de CuritibaRicardo Wang Brazil

Comite de Etica em Pesquisa da PUC - PR

Rua Imaculada Conceicao, 1155 - Predio Administrativo - 3 . andar

Prado Velho CEP: 80215-901

055016Sociedade Hospitalar Angelina

CaronDalton Precoma Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055016Sociedade Hospitalar Angelina

CaronDalton Precoma Brazil

Comite de Etica em Pesquisa do Hospital

Angelina CaronRodovia do Caqui, 1150

Campina grande do dul

PR 83430-000

055017 Hospital Barra d'or Miguel Rati BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055017 Hospital Barra d'or Miguel Rati BrazilComite de Etica em

Pesquisa da Rede D'orRua Almirante Baltazar, 383/435 Rio de Janeiro RJ -

055018Hospital Universitario Pedro

Ernesto - UERJDenilson Albuquerque Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055018Hospital Universitario Pedro

Ernesto - UERJDenilson Albuquerque Brazil

Comite de Etica em Pesquisa do Hospital

Universitario Pedro Emesto - HUPE

Avenida 28 de Setembro,v77 Vila Isabel Rio de Janeiro RJ 20551-030

The Medicines Company Confidential 1/8/2013 Page 9

Page 3328Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 11: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

055019Instituto de Cardiologia do Rio

Grande do SulIran Castro Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055019Instituto de Cardiologia do Rio

Grande do SulIran Castro Brazil

Comite de Etica em Pesquisa do Instituto de

Cardiologia do Rio Grande do Sul

Av. Princesa Isabel, 370 Porto Alegre RS 90620-000

055020 Hospital São Lucas da PUC do RS Luis Bodanese BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055020 Hospital São Lucas da PUC do RS Luis Bodanese BrazilComite de Etica em Pesquisa da PUCRS

Av. Ipiranga, 6690 3 Andar Porto Alegre RS 90610

055021 Hospital Mãe de Deus Euler Manenti BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055021 Hospital Mãe de Deus Euler Manenti BrazilComite de Etica em

Pesquisa do Hospital Mae de Deus

Av. Jose de Alencar, 286 Porto Alegre 90880480

055022 Hospital Bruno Born Joao Paulo Zouvi BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055022 Hospital Bruno Born Joao Paulo Zouvi BrazilCOEP - Comite de etica em

Pesquisa do Centro Universitario UNIVATES

Rua Avelino Tallini, 171 Bairro Universitario Lajeado RS 95900-000

055023Hospital São Vicente de Paulo -

Passo FundoRogerio Tadeu

TumeleroBrazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055023Hospital São Vicente de Paulo -

Passo FundoRogerio Tadeu

TumeleroBrazil

Comite de Etica em Pesquisa da Universidade de

Passo FundoCampu 1, KM 171 - BR 285, Passo Fundo RS 99001-970

055024Instituto de Cardiologia - Hospital

Regional de São JoséArthur Herdy Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055024Instituto de Cardiologia - Hospital

Regional de São JoséArthur Herdy Brazil

Comite de Etica em Pesquisa do Instituto de

Cardiologia de Santa Catrina

Rua Adolfo Donato da Silva - S/N Bairro Praia Comprida

Sao Jose SC 88103-460

055025 Hospital Israelita Albert Einstein Fabio deBrito-Junior BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055025 Hospital Israelita Albert Einstein Fabio deBrito-Junior BrazilComite de Etica em

Pesquisa do Hospital Albert Einstein (CEP Einstein)

Av. Albert Einstein, 627, 2 SS Morumbi Sao Paulo 05651-901

055026Faculdade de Medicina da USP -

INCOREulogio Martinez-Filho Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055026Faculdade de Medicina da USP -

INCOREulogio Martinez-Filho Brazil

CAPPesq - Comissao de Etica para analise de Projetos de Pesquisa

HCFMUSP

Rua Ovidio Pires de Campos 255 5 andar Cerqueira Cesar

Sao Paulo SP 05403-010

055027Universidade Federal do Estado

de São Paulo - Hospital São PauloAntonio Carvalho Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055027Universidade Federal do Estado

de São Paulo - Hospital São PauloAntonio Carvalho Brazil

Comite de etica em Pesquisa da Universidade

Federal de Sao Paulo

R. Botucatu, 572, 1 andar, cj. 14-V Clementino

Sao Paulo SP 04023-061

055028Irmandade Santa Casa de Misericórdia de São Paulo

Roberto Franken BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF Cep: 70.058-900

055028Irmandade Santa Casa de Misericórdia de São Paulo

Roberto Franken Brazil

Comite de Etica em Pesquisa da Irmandade

Santa Casa de Misericordia de Sao Paulo

Rua Santa Isabel, 305 4. Santa Cecilia Sao Paulo SP 01221-010

The Medicines Company Confidential 1/8/2013 Page 10

Page 3329Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 12: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

061001 Canberra Hospital Ahmad Farshid AustraliaACT Human Research Ethics

Committee11 Moore Street Canberra City ACT 2601

061002 Gosford Hospital Brendan Gunalingam AustraliaNorthern Sydney and

Central Coast Area Health Service

Coast Human Research Ethics Committee, Area Executive Office - Gosford Hospital

Holden StreetGosford 2250 NSW

061003 Liverpool Hospital Craig Jeurgens AustraliaResearch and Ethics Office,

Liverpool HospitalElizabeth Street Liverpool NSW 2170

061005 Concord Hospital Harry Lowe AustraliaHuman Research Ethics

CommitteeConcord Hospital Research Office, Level 1,

Building 75 Hospital RoadConcord NSW 2139

061007 Nepean Hospital Hisham (Sam) Hallani AustraliaSydney West Area Health Service Human Research

Ethics Committee

Court Building, Nepean Campus Derby Street

Penrith NSW 2751

061009 Royal North Shore Hospital Greg Nelson AustraliaNorthern Sydney Central Coast Area Health Human Research Ethics Committee

Royal North Shore Hospital, Level 4 Vindin House Pacific Highway Street

Leonards NSW 2065

061012 Boxhill Hospital Gishel New AustraliaEastern Health Research and Ethics Committee

16 Arnold Street Box Hill Victoria 3128

061013 Epworth Hospital Ronald Dick AustraliaThe Epworth Foundation

HREC, Level 5LP89 Bridge Road Richmond VIC 3121

061015 Royal Melbourne Hospital Jeffery Lefkovits AustraliaHuman Research Ethics Committee - Melbourne

HealthRoyal Melbourne Hospital Parkville Victoria 3050

061017 The Alfred Hospital Stephen Duffy AustraliaThe Alfred Hospital Ethics

Committee, The Alfred Hospital

Commercial Road Melbourne VIC 3004

061018 Prince Charles Hospital JHN Betts AustraliaMr. Philip Lee, Executive Director, Office of Distric

Research and EthicsThe Prince Charles Hospital Rode Road Chermside QLD 4032

061019 Townsville Hospital Raibhan Yadav Australia

The Townsville Health Service District Human Research and Ethics

Committee

The Townsville Hospital 100 Angus Smith Drive

Douglas QLD 4814

061020 Princess Alexandra Hospital Paul Garrahy AustraliaPrincess Alexandra Hospital

Human Research Ethics Committee

Princess Alexandra Hospital Ipswich Road Woolloongabba Brisbane 4102

061021 Ashford Hospital Ron Lehman AustraliaBellberry Human Research Ethics Committee, 1st Floor

71 Anzac Highway Ashford SA 5035

061022 Flinders Medical Center Philip Aylward AustraliaFlinders Clinical Research Ethics Committee, Flinders

Medical Centre1 Flinders Drive Bedford Park SA 5042

061023 Queen Elizabeth Hospital John Horowitz AustraliaEthics of Human Research

CommitteeThe Queen Elizabeth Hospital, 4th Floor Maternity Building 28 Woodville Road

Woodville SA 5011

061024 Royal Adelaide Hospital Matthew Worthley Argentina RAH Ethics Committee c/o Level 3 Hanson Centre Frome Road Adelaide SA 5000

061025Royal Brisbane & Womens

HospitalDavid Cross Australia

Royal Brisbane and Women's Hospital Human

Research Ethics Committee

Royal Brisbane and Women's Hospital Herston Road

Herston QLD 4029

061028 Royal Perth Hospital Jamie Rankin AustraliaEthics Committee, Level 3,

Kirkman HouseRoyal Perth Hospital Wellington Street Perth WA 6000

061029 The Mount Hospital Peter Thompson AustraliaMount Hospital Ethics

Committee, Mount Hospital150 Mounts Bay Road Perth WA 6000

061030 Royal Hobart HospitalPhilip Roberts-

ThompsonAustralia

Human Research Ethics Committee (Tasmania)

Research and Development Office, University of Tasmania Churchill Avenue

Sand Bay TAS 7005

061032 Wesley Hospital David Cross AustraliaUHC Human Research Ethics

CommitteeThe Wesley Hospital, Moorlands House 451

Coronation DriveAuchenflower QLD 4066

061033Cardiology Department, Gold

Coast HospitalRohan Jayasinghe Australia

Gold Coast Hospital Ethics Dept

108 Nerang Rd Southport QLD 4215

061034 Holy Spirit Northside Hospital Con Aroney AustraliaSisters of Charity and Holy Spirit Health Service QLD

Ltd.

Human Research Ethics Committee C/-Executive - Level 2, Holy Spirit Northside

Hospital, Rode Road, ChermsideBrisbane QLD 4032

The Medicines Company Confidential 1/8/2013 Page 11

Page 3330Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 13: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

064001 Auckland City Hospital Ralph Stewart New ZealandMulti Region Ethics

Committee c/o Ministry of Health

P.0. Box 5013 Wellington -

064002 Waikato Hospital Gerard Devlin New ZealandMulti Region Ethics

Committee c/o Ministry of Health

P.0. Box 5013 Wellington -

064003 Wellington Hospital Scott Harding New ZealandMulti Region Ethics

Committee c/o Ministry of Health

P.0. Box 5013 Wellington -

064004 Christchurch Hospital John Elliott New ZealandMulti Region Ethics

Committee c/o Ministry of Health

P.0. Box 5013 Wellington -

064005 Dunedin Hospital Gerard Wilkins New ZealandMulti Region Ethics

Committee c/o Ministry of Health

P.0. Box 5013 Wellington -

064006 Middlemore Hospital Douglas Scott New ZealandMulti Region Ethics

Committee c/o Ministry of Health

P.0. Box 5013 Wellington -

080001Central Clinical Hospital of

Ukrainian RailwayIgor Kraiz Ukraine

Central Ethics Committee of Ministry of Health of

Ukraine,5, Narodnogo Opoichennia Kyiv 03680 MSP

080002Gusak Institute of Urgent and

Recovery Surgery of AMSUMykola Vatutin Ukraine

Central Ethics Committee of Ministry of Health of

Ukraine,5, Narodnogo Opoichennia Kyiv 03680 MSP

080003 Odesa Regional Clinical Hospital Anatoliy Polyakov UkraineCentral Ethics Committee of

Ministry of Health of Ukraine,

5, Narodnogo Opoichennia Kyiv 03680 MSP

080004National Scientific Center "M.D.

Strazhesko Institute of Cardiology"

Yury Sokolov UkraineCentral Ethics Committee of

Ministry of Health of Ukraine,

5, Narodnogo Opoichennia Kyiv 03680 MSP

080005M. O. Semashka Republic Clinical Hospital. № 1 of S.I.Georgiyevsky

Crimea State Medical Univ.Olexandr Legkonogov Ukraine

Central Ethics Committee of Ministry of Health of

Ukraine,5, Narodnogo Opoichennia Kyiv 03680 MSP

091001 Apollo Gleneagles Hospital Aftab Khan IndiaApolla Gleneagles Hospitals

Ltd., Institutiona Ethics Committee

58 Canal Circular Road KolkataWest

Bengal700054

091002 Osmania General Hospital Sampath Kumar IndiaEthics Committee Osmainia

Hospital Medical CollegeKoti Hyderabad

Andhra Pradesh

500095

091003 West Fort Hi-Tech Hospital Ltd Padinhare Mohanan IndiaWest Fort Hi-Tech Hospital

Ltd.Institutional Ethics Committee P.B No-930,

PunkunnamThrissur Kerala 680002

091004Max Devki Devi Heart & Vascular

InstituteSumeet Sethi India

Max Devki Devi Heart and Vascular Institute

Institutional Review Board 2 Press Enclave Road

SaketNew Delhi

110017

091005 Care Hospital Maddury Rao IndiaCare Foundation, Care

HospitalInstitutional Ethics Committee Road No 1,

Banjara HillsHyderabad

Andhra Pradesh

500034

091007Bhagwan Mahaveer Jain Heart

Research CentreDr. S.S. Ramesh India

Cardiac Research Academy and Srinivasa Cardiology Centre Pvt. Ltd., Institute

Review Board

Millers Road Vasanthnagar BangaloreKarnatak

a560052

091008 S.A.L.Hospital Keyur Parikh IndiaSAL Hospital and Medical

Institute, Ethics CommitteeOpp. Doordarshan, Drive In Road, Ahmedabad Gujarat 380054

091009 Vikram Hospital & Heart Care Arun Srinivas IndiaVikram Hospital Ethics

CommitteeVikram Hospital and Heart Care #46,

Vivekananda RoadMysore

Karnataka

570 020

091011 Medwin Hospital Ramesh Babu IndiaMedwin Hospitals, Institutional Ethics

Committee

Raghava Ratna Towers Chirag Ali Lane, Nampally

HyderabadAndhra Pradesh

500001

091012Sanjay Gandhi Hospital Post Graduate Institute of Medical

SciencesNakul Sinha India

Sanjay Gandhi Post Graduate Institute of

Medical Sciences

Institutional Ethics Committee Raebareli Road

LucknowUttar

Pradesh226014

The Medicines Company Confidential 1/8/2013 Page 12

Page 3331Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 14: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PCI (TMC-CAN-05-02) PI and IRB/EC List

Site Number Site Name PI Name Country Sub-Study IRB/EC Name Address City State Zip

091013 M.S.Ramaiah Memorial Hospital Dr. VS Prakash India

M.S. Ramaiah Medical College and Teaching

Hospital, Ethical Review Board

MSR Nagar, MSRIT Post, BangaloreKarnatak

a560054

091014 Grant Medical Foundation Shirish Hiremath IndiaPoona Medical Research

FoundationThe Ethics Committee 40 Sassoon Road Pune 411011

091015 B M Birla Insitute of Cardiology Anil Mishra IndiaB.M. Birla Heart Research Centre Ethics Committee

1/1 National Library Avenue KolkataWest

Bengal700027

091016 Fortis Escorts Hospital Sanjeeb Roy IndiaFortis Escorts Hospital,

Institutional Ethics Committee

Jawaharlal Nehru Marg Malviya Nagar Jaipur 302017

091018 Delhi Heart and Lung Institute Kamal Sethi IndiaEthics Committee of Delhi Heart and Lung Institute

3-MM II, Panchkulan Road New Delhi 110055

091019 Dharma Vira Heart Centre Ashwani Mehta India Sir Ganga Ram Hospital Ethics Committee Old Rajinder Nagar, New Delhi 110060

091020Krishna Heart Institute& Super

Speciality HospitalTejas Patel India

Ethics Committee of Krishna Heart Institute

Krishna Heart and Super Specialty Institute, Ghuma

Ahmedabad Gujarat 380058

091021Escorts Heart Institute &

Research CenterSuman Bhandari India

Independent Ethics Committee

Escorts Heart Institute and Research Center Limited, Okhla Road

New Delhi 110025

091022KEM Hospital and Research

CenterGadkari Milind India

KEM Hospital Research Centre

Ethics Committee Sardar Moodliar Road, Rasta Peth

Pune 411011

091023All India Institute of Medical

SciencesBalram Bhargava India

All India Institute of Medical Sciences, Ethics Committee

Ansari Nagar New Delhi 110029

091024Jehangir Clinical Development

CentreJaskaran Dugal India

Hirabai Cowasji Jehangir Medical Research Institute

and Jehangir Clinical Development Center - Ethics

Committee,

Jehangir Hospital Premises, 32, Sassoon Road,

PuneMaharas

htra411001

091025Krishna Heart and Super

Speciality InstituteTejas Patel India

Ethics Committee of Krishna Heart Institute

Krishna Heart and Super Specialty Institute, Ghuma

Ahmedabad Gujarat 380058

091026 Sahyadri speaciality Hospital Milind Gadkari India Sahyadri Speciality HospitalEthics Committee Plot No. 30C,

Erandawane,Pune 411004

095001 Diagnostic Services Clinic Tamaz Shaburishvili Georgia xDiagnostic Services Clinic

Ltd.33, Chavchavadze avenue, Tbilisi 0179

095002 Emergency Cardiology Centre Gulnara Chapidze Georgia xEC of Emergency cardiology centre by Academician G.

Chapidze4, Lubliana Street, Tbilisi 0159

095003Clinic of Angiocardiology

“ADAPTI”M. Mamatsashvili Georgia x

Ethics Committee of Clinic of Angiocardiology "ADAPTI"

16, Kavtaradze str., Tbilisi 0186

095004Tbilisi State Medical University Alexandre Aladashvili University

ClinicIrakli Khintibidze Georgia x

Ethics Committee of Tbilisi State Medical University Alexandre Aladashvili

University Clinic

103, D Uznadze str. Tbilisi 0102

The Medicines Company Confidential 1/8/2013 Page 13

Page 3332Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 15: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

301013 Toledo Hospital Ahed Nahhas United StatesProMedica Health System

IRB

c/o Development, Grants & Research Administration Conrad Jobst Tower, Suite

900, 2142 N. Cove Blvd.Toledo OH 43606

301029Wellmont Bristol Regional

Medical CenterPierre Istfan United States

Wellmont Bristol Regional Medical Center IRB

One Medical Park Blvd. Bristol TN 37620

301031 Baystate Medical Center Marc Schweiger United StatesJessica Young, JD Chair, Institutional Review Board

Baystate Medical Center 759 Chestnut Street Springfield MA 01199

301039 Marin General Hospital Joel Sklar United StatesMarin General Hospital,

Institutional Review Board1350 S. Eliseo, Suite 240 Greenbrae CA 94904

301044 Valley Hospital Carey Hirsch United States The Valley Hospital-IRB 223 N. Van Dien Avenue Ridgewood NJ 07450

301045 Winchester Medical Center Ajay Virmani United StatesWinchester Medical Center

IRB1840 Amherst Street Winchester VA 22601

301049 Rapid City Regional Hospital Norman Ferrier United States Regional Health IRB 353 Fairmont Blvd Rapid City South Dakota 57701301058 Jewish Hospital Nicholaos Xenopoulos United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301085Sentara Norfolk General

HospitalPaul Mahoney United States

Chesapeake Research Review, Inc

7063 Columbia Gateway Drive Ste 110 Columbia Maryland 21046

301108 Geisinger Medical Center James Blankenship United States Institutional Review BoardOffice of Research Programs 100 North

Academy AvenueDanville PA 17822-2603

301109 Northern Michigan Hospital Louis Cannon United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301130 York Hospital Paul Tolerico United StatesWellspan Institutional Review Board, Emig

Research Center1001 South George Street York PA 17405

301138 Henry Ford Hospital Adam Greenbaum United StatesHenry Ford Hospital,

Institutional Review BoardCFP B-035 2799 West Grand Blvd Detroit MI

Detroit, MI 48202

301145 Emory University Hospital John Douglas United StatesEmory University,

Institutional Review Board1599 Clifton Road, 5th Floor Atlanta GA 30322

301147 Duke University Medical Center Sunil Rao United StatesDuke University Health System, Institutional

Review Board2424 Erwin Road Suite 405 Durham NC 27705

301150 Bridgeport Hospital Mitchell Dreisman United States Bridgeport Hospital, Institutional Review Board 267 Grant Street Bridgeport CT 06610

301173 Edward Hospital Mark Goodwin United StatesEdward Hospital and Health

Services Institutional Review Board

801 S. Washington St. Naperville IL 60540

301245 Jersey Shore Medical Center Nelson LaMarche United StatesMeridian Health IRB, Jersey

Shore University Medical Center

Wellmess Center, Suite 200 1945 State Rt 33, P.O. Box 397

Neptune NJ 07754

301234 Saint Francis Hospital Shahriar Dadkhah United StatesSaint Francis Hospital,

Institutional Review Board355 Ridge Ave Evanston IL 60202

301233Hackensack University Medical

CenterJoseph DeGregorio United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301174 University of Iowa Hospital Phillip Horwitz United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301216 Lakeland Hospital St. Joseph Thomas Pow United StatesLakeland Regional Medical

Center1324 Lakeland Hills Blvd. Lakeland FL 33805

301210Maricopa Integrated Health

SystemsJay Kaufman United States

MIHS Institutional Review Board

2601 E. Roosevelt St. Phoenix AZPhoenix, AZ

85008301219 John Muir Hospital Agustin Argenal United States John Muir Health IRC 2540 East Street Concord California 94520

301167Foundation for Cardiovascular

MedicineMaurice Buchbinder United States

Scripps Health Green Hospital IRB #2 (Human

Subjects Committee)11025 North Torrey Pines Road Suite 200 La Jolla California 92037

301201Cedars-Sinai Medical

Center/CVICBruce Samuels United States Cedars-Sinai Medical Center 8383 Wilshire Blvd., Suite #742 Beverly Hills CA 90211

301206Providence Holy Cross Medical

CenterKenneth Tam United States

Providence Holy Cross Medical Center

15301 Rinaldi Street P.O. Box 9600 Mission Hills CA 91345

301106 Northridge Hospital Kevin Ariani United StatesNorthridge Hospital Medical

Center, IRB18350 Roscoe Blvd. Northridge CA 91325

301246 St. Joseph Hospital Michael Chan United StatesSt. Joseph Hospital

Institutional Review Board1100 West Stewart Drive Orange California 92868

301116 San Diego VA Medical Center William Penny United StatesUCSD Human Research

Protection ProgramLa Jolla Village Professional Center 8950

Villa La Jolla, Suite A208San Diego CA 92037

301141Kaiser Permanente Medical

CenterRobert Lundstrom United States

Kaiser Permanente Northern California Institutional Review

Board1800 Harrison St. 16th Fl

Kaiser Foundation Research Institute 1800 Harrison St. 16th Fl

Oakland CA 94612-3431

301236 O'Connor Hospital Mehrdad Rezaee United States IRB Committee O'Connor Hospital 2105 Forest Avenue San Jose CA 95128

301249Western Medical Center Santa

AnaHarinder Gogia United States

Western Medical Center Santa Ana IRB

1001 N. Tustin Ave Santa Ana California 92705

301024 Harbor-UCLA Medical Center William French United StatesJohn F. Wolf, MD Human

Subjects Committee

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center 1124 W.

Carson Street, N-14Torrance CA 90502

301117 Medical Center of Aurora Jerry Greenberg United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

The Medicines Company Confidential 10/29/2012 Page 1

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 16: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

301182 University of CT Health Center Michael Azrin United StatesUniversity of CT Health

Center IRB263 Farmington Ave Farmington CT 06030

301212 Christiana Care Health Services Michael Stillabower United StatesChristiana Care Health System, Institutional

Review Board501 West 14th Street Wilmington DE 19889-1668

301180University of Florida Health

Science CenterDominick Angiolillo United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301015Palm Beach Gardens Medical

CenterEdward Mostel United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301202 Winter Haven Hospital Boris Nunez United StatesWinter Haven Hospital

Institutional Review Board200 Avenue F, NE, Winter Haven Florida 33881

301071Piedmont Hospital / Fuqua

Heart Center of AtlantaWilliam Ballard United States Piedmont Hospital

Institutional Review Board 1968 Peachtree Road NW

Atlanta GA 30309

301076 Emory Crawford Long Hospital Michele Voeltz United StatesEmory University,

Institutional Review Board1599 Clifton Road, 5th Floor Atlanta GA 30322

301185 Atlanta VA Medical Center Kreton Mavromatis United StatesEmory University,

Institutional Review Board1599 Clifton Road, 5th Floor Atlanta GA 30322

301222Northeast Georgia Medical

CenterPradyumna Tummala United States

Northeast Georgia Health System

Institutional Review Board 200 S. Enota Drive, Suite 416

Gainesville GAGainesville, GA

3050

301248 St. Luke's Hospital Richard Kettelkamp United StatesMercy & St. Luke's Institutional Review

Committees701 Tenth Street SE Cedar Rapids IA 52403-1292

301073 St. Francis Hospital Joseph Stella United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301132 Jesse Brown VAMC Adhir Shroff United StatesOffice for the Protection of

Research Subjects1737 W. Pollk Street, M/C 672 203

Administrative Office BuildingChicago Illinois 60612

301133University of Illinois at Chicago

Medical CenterAdhir Shroff United States

Office for the Protection of Research Subjects

1737 W. Pollk Street, M/C 672 203 Administrative Office Building

Chicago Illinois 60612

301160 Rush University Medical Center Gary Schaer United StatesRush University Medical

Center, Institutional Review Board

Research and Clinical Trials Office 1725 W. Harrison, Suite 439

Chicago IL 60612

301200University of Chicago Medical

CenterJohn Lopez United States

University of Chicago, Institutional Review Board

McGiffert Hall, 2nd floor 5751 S. Woodlawn Avenue

Chicago IL 60637

301036Northern Indiana Research

AllianceSteve Orlow United States Lutheran Health Nework IRB 7950 W. Jefferson Blvd. Fort Wayne IN 46804

301188 Suburban Hospital Kenneth Kent United States Suburban Hospital IRB 8600 Old Georgetown Road Bethesda MD 20814

301114Ingham Regional Medical

CenterJoel Cohn United States

Ingham Regional Medical Center IRB

401 W. Greenlawn Lansing MI 48910

301178Upper Michigan Cardiovascular Associates (Marquette General

Health System)Thomas LeGalley United States

Marquette General Health System

Institutional Review Board 420 W. Magnetic Marquette MI 49855

301189 Providence Hospital Marcel Zughaib United StatesProvidence Hospital and

Medical Centers, Institutional Review Board

16001 W. Nine Mile Rd. Southfield MI 48075

301070St. Mary's Medical Center,

Duluth ClinicWilson Ginete United States

St. Mary's/Duluth Clinic Health System

Institutional Review Board 400 East Third Street

Duluth MN 55805

301129 Kansas City Heart Foundation Eric Hockstad United StatesPatient Advocacy Council,

Inc.601 El Air Blvd., Suite 315 Mobile AL 36606

301177 Wake Heart Research J. Tift Mann United States WakeMed IRB 3000 New Bern Avenue Raleigh NC 27610

301104 Dakota Clinic, Innovis Health Garfield Grimmett United StatesDakota Clinic LTD/Dakota

Specialty Institute1702 South University Drive Fargo ND 58103

301187 Altru Health System Abdel Ahmed United States Altru Health System IRB 1200 South Columbia Road Grand Forks North Dakota 58201

301220 Jack D. Weiler Hospital Vankeepuram Srinivas United States Montefiore Medical CenterInstitutional Review Board 3308

Rochambeau AveBronx NY 10467

301123 Winthrop University Hosp Kevin Marzo United States Winthrop University HospitalInstitutional Review Board 222 Station

Plaza, Suite 521Mineola NY 11501

301078St. Vincent Catholic Medical

CenterCezar Staniloae United States

Integrated Scientific & Ethical Review Board

170 West 12th Street Staff House New York NY 10011

301192 Stony Brook University Hospital Luis Gruberg United StatesChesapeake Research

Review, Inc7063 Columbia Gateway Drive Ste 110 Columbia Maryland 21046

301159 University Hospital Tarek Helmy United StatesInstitutional Review Board

Medical Center University of Cincinnati

P.O. Box 670567 G-08 Wherry Hall, ML 0567, Eden Avenue and Albert Sabin Way

Cincinnati Ohio 45267-0567

301205 Good Samaritan Hospital Dogan Temizer United StatesTriHealth IRB, Good Samaritan Hospital

Hatton Institute Level 11 Unit J 375 Dixmyth Avenue

Cincinnati Ohio 45220

301213 Metro Health Medical Center Kathleen Quealy United States MetroHealth IRBMetroHealth Medical Center 2500

MetroHealth DriveCleveland Ohio 44109

301079 MedCentral Health System Gregory Eaton United StatesMedCentral Healthy System-

IRBTerry Weston, MD, Chairman 335 Glessner

AvenueMansfield OH 44903

301217 DMH Regional Medical Center Charles O'Shaughnessy United StatesEMH Regional Medical

Center Institutional Review Board

630 East River Street Elyria OH 44035

The Medicines Company Confidential 10/29/2012 Page 2

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 17: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

301105 Western PA Hospital Venkatraman Srinivasan United StatesThe Western Pennsylvania

HospitalThe Institutional Review Board (IRB) 4800

Friendship AvenuePittsburg PA 15224

301115 Anderson Area Medical Center Brent McLaurin United States Andmed Health IRB 800 North Fant Street Anderson South Carolina 29621

301097University of Tennesee Medical

CenterJ. Christopher Scott United States

Crescent City Institutional Review Board

2820 Canal Street New Orleans Louisiana 70119

301223 Centennial Medical Center Paul Myers United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010301183 The Heart Hospital of Austin Roger Gammon United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301098 UT-Galveston Charles Lui United StatesJames Patterson, Chair,

UTMBInstitutional Review Board Galveston TX 77555-0158

301048Trinity Mother Francis Hospital

East Texas Medical CenterRobert Smith United States Mother Frances Hospital IRB 820 S. Beckham Tyler Texas 75701

301124 Detar Hospital Harish Chandna United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301211 Dallas VA Medical Center Emmanouil Brilakis United StatesDallas VAMC Insittutional

Review BoardResearch Building 43, Mail Code 151 4500

S. Lancaster RoadDallas Texas 75216

301190Swedish Heart & Vascular

InstituteRJeffrey Westcott United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301208University of Wisconsin School of Medicine and Public Health

Amish Raval United States University of WisconsinHealth Sciences Institutional Review Board,

B3088 VA Medical Center 2500 Overlook Terrace

Madison WI 53705

301065 Chattanooga Heart Institute James Hoback United States

UT College of Medicine Institutional Review

Committee at Erlanger Medical Center

960 East Third Street, Suite 102 Chattanooga TN 37403

301055 VAMC - GLAHS Ramin Ebrahimi United StatesVA Medical Center-Greater

Los Angeles Healthcare System IRB

Research and Development Office 11301 Wilshire Blvd., Bldg. 114, Mail Code 151

Los Angeles CA 90073

301060 Anaheim Memorial Hospital Harinder Gogia United StatesWestern Medical Center

Santa Ana IRB1001 N. Tustin Ave Santa Ana California 92705

301161Connecticut Clinical Research,

LLCEdward Kosinski United States

St. Vincent's Medical Center, Institutional Review

Board2800 Main Street Bridgeport CT 06606

301030 CVMS Research Institute, LLC Michael Stein United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301221The Heart and Vascular

Institute of FloridaAndrew Rosenthal United States

Bayfront Medical Center, Institutional Review Board

701 6 Street South St. Petersburg FL 33701

301111 St. Josephs Hospital of Atlanta Steven Eisenberg United StatesSaint Joseph's Hospital of

Atlanta Institutional Review Board

5673 Peachtree Dunwoody Road Suite 650 Atlanta Georgia 30342

301122 Clarian Health Partners Jeffrey Breall United StatesClarian Health Partners, Inc./Methodist Hospital

Institutional Review BoardI-65 @ 21st Street P.O. Box 345 Indianapolis IN 46206

301068 St. Vincent's Hospital Luigi Pacifico United States

Saint Vincent Hospital/ Fallon Clinic/ Fallon

Community Health Plan, Institutional Review Board

Worcester Medical Center 123 Summer Street

Worcester MA 01608

301203 Mayo Clinic - Rochester David Holmes United StatesMayo Foundation

Institutional Review Board200 First SW Rochester MN 55905

301043 St. John's Hospital David Cochran United StatesSt. John's Institutional

Review Board1235 E. Cherokee Street Springfield MO 65804

301215Washington University/Barnes-

Jewish HospitalRichard Bach United States Washington University

Human Research Protection Office Campus Box 8089, 660 S. Euclid

St. Louis MOSt. Louis, MO

63110

301171Parkway Cardiology Associates,

PC/Methodist Medical CenterMukesh Sharma United States

Covenant Health Institutional Review Board

280 Fort Sanders West Boulevard KnoxvilleBuilding 4, Suite 218

TN 37922

301207 University Cardiology Group Jose Suarez United States

Texas Tech University Health Sciences Center,

Lubbock/Odessa Institutional Review Board

3601 4th Street, MS 8146 Lubbock Texas 79430-8146

301127University of Virginia Health

SystemLawrence Gimple United States

University of Virginia Institutional Review Board

for Health Sciences ResearchOne Morton Drive Suite 400, Box 5 Charlottesville Virginia 22903

301034 Lynchburg General Hospital Thomas Nygaard United StatesCentra Health Inc.

Institutional Review BoardVirginia Baptist Hospital 3300 Rivermont

AvenueLynchburg VA 24503

301096Providence Everett Medical

CenterMahesh Mulumudi United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

301251 Mercy Medical Center Richard Kettelkamp United StatesMercy & St. Luke's Institutional Review

Committees701 Tenth Street SE Cedar Rapids IA 52403-1292

The Medicines Company Confidential 10/29/2012 Page 3

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 18: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

307013Coronary Care Unite,

Cardiology Research InstituteValentin Markov

Russian Federation

Local EC of Institution of Russian Academy of

Sciences

Research Institute of Cardiology of Siberian branch of Russian Academy of Medical

Sciences Kievskaya Str., 111-ATomsk 634012

307011Altay Regional Cardiology

DispensaryAlexey Duda

Russian Federation

Local EC of Regional State Institution of Healthcare

Altay Regional Cardiology Dispensary 46 Malakhova St.

Barnaul 656055

307002Cardiology, Saratov Institute of

CardiologyPavel Dovgalevsky

Russian Federation

EC at the Federal Service on Surveillance in HC and Social Development of

Russian Federation

4, Slavyanskaya sq., building 1 Moscow 109012

307004 Central Clinical Hospital (CCH) Aleksey GruzdevRussian

Federation

EC at the Federal Service on Surveillance in HC and Social Development of

Russian Federation

4, Slavyanskaya sq., building 1 Moscow 109012

307012cardiology, Clinical Centre

"Cardiology"Svetlana Kalinina

Russian Federation

EC at the Federal Service on Surveillance in Healthcare and Social Development of

Russian Federation

8, Petrovskiy Boulevard, building 2 Moscow 127051

307003 Cardiology, City Hospital #15 Victor LusovRussian

Federation

EC at the Federal Service on Surveillance in HC and Social Development of

Russian Federation

4, Slavyanskaya sq., building 1 Moscow 109012

307003 Cardiology, City Hospital #15 Victor LusovRussian

Federation

Local EC of State Educational Institutional of

Higher Professional Education

Russian State Medical University of Roszdrav 1 Ostrovityanova str.,

Moscow 117997

307012cardiology, Clinical Centre

"Cardiology"Svetlana Kalinina

Russian Federation

Local EC at the Federal Service on Surveillance in

HC and Social Development of Russian Federation

Clinical Diagnostic Centre Cardiology 8 March str., 78a

Ekaterinburg 620144

307004 Central Clinical Hospital (CCH) Aleksey GruzdevRussian

Federation

Local EC of Federal State Institution Central Clinical Hospital with polyclinic of the administrative dept. of

the President Russian Federation

15, Marshal Timoshenko str., Moscow 121356

307011Altay Regional Cardiology

DispensaryAlexey Duda

Russian Federation

EC at the Federal Service on Surveillance in Healthcare and Social Development of

Russian Federation

8, Petrovskiy Boulevard, building 2 Moscow 127051

307013Coronary Care Unite,

Cardiology Research InstituteValentin Markov

Russian Federation

EC at the Federal Service on Surveillance in Healthcare and Social Development of

Russian Federation

8, Petrovskiy Boulevard, building 2 Moscow 127051

307002Cardiology, Saratov Institute of

CardiologyPavel Dovgalevsky

Russian Federation

Local EC of Federal State Institution, Saratov

Research Institute of Cardiology of Rosszdrav.

Chernyshevskogo str. 141, Saratov 410028

307007AMI, Research Institute of Emergency Medical Care

Victor KostenkoRussian

Federation

EC at the Federal Service on Surveillance in HC and Social Development of

Russian Federation

4, Slavyanskaya sq., building 1 Moscow 109012

307007AMI, Research Institute of Emergency Medical Care

Victor KostenkoRussian

Federation

Local EC of State Institution St. Petersburg Scientific Research Institute for

Emergency Medical Care named after I.I. Dzhanilidze

3 Budapeshtskaya str. St. Petersburg 192242

307014cardiology, Ural SMA b.o. City

Clinical Hospital #41 Olga Smolenskaya

Russian Federation

EC at the Federal Service on Surveillance in Healthcare and Social Development of

Russian Federation

8, Petrovskiy Boulevard, building 2 Moscow 127051

307014cardiology, Ural SMA b.o. City

Clinical Hospital #41 Olga Smolenskaya

Russian Federation

Local EC of OOO City Hospital #41

25, Nachdiva Vasilyeva St., Ekaterinburg 620043

307006 Cardiology, City Hospital #23 Elena VasilievaRussian

Federation

EC at the Federal Service on Surveillance in Healthcare and Social Development of

Russian Federation

8, Petrovskiy Boulevard, building 2 Moscow 127051

The Medicines Company Confidential 10/29/2012 Page 4

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 19: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

307006 Cardiology, City Hospital #23 Elena VasilievaRussian

Federation

Local EC of State Educational Institution of

Higher Professional Education, Moscow State University Medicine and

Dentistry of Roszdrav

20/1 De;egatslaya str., Moscow 127473

307009Cardiology and cardiosurgery,

Kemerovo Cardiology Dispensary

Olga BarbarashRussian

Federation

EC at the Federal Service on Surveillance in Healthcare and Social Development of

Russian Federation

8, Petrovskiy Boulevard, building 2 Moscow 127051

307009Cardiology and cardiosurgery,

Kemerovo Cardiology Dispensary

Olga BarbarashRussian

Federation

Local EC of Municipal HC Institution Kemerovo Cardiology Dispensary

6, Sosnovy blvd., Kemerovo 650002

307015Railway Clinical Hospital of

'RZhD' on the station Novosibirsk-Glavny

Svetlana BaumRussian

Federation

EC at the Federal Service on Surveillance in Healthcare and Social Development of

Russian Federation

8, Petrovskiy Boulevard, building 2 Moscow 127051

307015Railway Clinical Hospital of

'RZhD' on the station Novosibirsk-Glavny

Svetlana BaumRussian

Federation

Local EC of Non-State HC Institution, Rd Clinical

Hospital on the Novosibirsk-Glavny station of public

corporation Russian Railways

Vladimirovsky spusk, 2a Novosibirsk 630003

307010Department of Cardiology, St.Petersburg State Medical Academy n.a. I.I. Mechnikov

Svetlana BolduevaRussian

Federation

EC at the Federal Service on Surveillance in HC and Social Development of

Russian Federation

4, Slavyanskaya sq., building 1 Moscow 109012

307010Department of Cardiology, St.Petersburg State Medical Academy n.a. I.I. Mechnikov

Svetlana BolduevaRussian

Federation

Local EC of State Educational Institution of

Higher Professional Education,

Saint Petersburg State Medical Academy named after I.I. Mechnicov of Roszdrav 47,

Piskarevsky pr.,St. Petersburg 195067

307001Cardiology, Voronezh Regional

HospitalOleg Azarin

Russian Federation

EC at the Federal Service on Surveillance in Healthcare and Social Development of

Russian Federation

8, Petrovskiy Boulevard, building 2 Moscow 127051

307001Cardiology, Voronezh Regional

HospitalOleg Azarin

Russian Federation

Local EC of state Institution of Health, Voronezh

regional clinical hospital #1151 Moskovsky pr-t Voronezh 394066

331001 Medisch Centrum Alkmaar Hans de Swart Netherlands METC Noord-Holland Wilhelminalaan 12 1815 JD Alkmaar NA

331002Catharina Hospital dept. R&D,

CardiologyRolf Michels Netherlands METC Noord-Holland Wilhelminalaan 12 1815 JD Alkmaar NA

331004 Rijnstate Hospital R. Tjon Netherlands METC Noord-Holland Wilhelminalaan 12 1815 JD Alkmaar NA

331005Academic Medical Center

AmsterdamRobbert de Winter Netherlands METC Noord-Holland Wilhelminalaan 12 1815 JD Alkmaar NA

331006Leiden University Medical

CenterJ Jukema Netherlands METC Noord-Holland Wilhelminalaan 12 1815 JD Alkmaar NA

334001 Hospital La Paz Guillermo Galeote SpainEthic Committee Clinico San

Carlos HospitalNA Madrid 28040

334002 Hospital 12 de Octubre Felipe Hernández SpainEthic Committee Clinico San

Carlos HospitalNA Madrid 28040

334003 Hospital Vall D´Hebrón Jaume Figueras SpainEthic Committee Clinico San

Carlos HospitalNA Madrid 28040

334004 Hospital Clinico San Carlos Rosana Hernández SpainEthic Committee Clinico San

Carlos HospitalNA Madrid 28040

334005 Hospital Infanta CristinaJosé Ramón López-

MinguezSpain

Ethic Committee Clinico San Carlos Hospital

NA Madrid 28040

334007Hospital Clinico Universitario

SantiagoJosé Ramón González

JuanateySpain

Ethic Committee Clinico San Carlos Hospital

NA Madrid 28040

334006 Hospital Virgen de la Salud Jose Moreu Burgos SpainEthic Committee Clinico San

Carlos HospitalNA Madrid 28040

334008 Hospital San Juan de Alicante Ramón López Palop SpainEthic Committee Clinico San

Carlos HospitalNA Madrid 28040

339001 Ospedale Della Misericordia Bernardo Cortese Italy Comitato Etico LocaleComitato per la Sperimentazione dei

Farmaci c/o UO Farmaceutica Territoriale Via Genova 6/d

Grosseto 58100

327010 Bloemfontein Medi Clinic Nico Van Der Merwe South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157327007 Olivedale Clinic Robert Routier South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157

349001 Asklepios Klinik Langen Hans-Georg Olbrich Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission

Ratzeburfer Allee 160Lubeck 23538

The Medicines Company Confidential 10/29/2012 Page 5

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 20: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

349002Klinikum Kroellwitz / Innere

Medizin IIIMichael Buerke Germany Universitat zu Lubeck

Medzinische Faklutat, Ethikkommission Ratzeburfer Allee 160

Lubeck 23538

327002 Wilgers Hospital John Bennett South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157

349003Vivantes Klinikum im

FriedrichshainStefan Hoffmann Germany Universitat zu Lubeck

Medzinische Faklutat, Ethikkommission Ratzeburfer Allee 160

Lubeck 23538

349004Universitaetsklinikum

Schleswig-HolsteinPeter Radke Germany Universitat zu Lubeck

Medzinische Faklutat, Ethikkommission Ratzeburfer Allee 160

Lubeck 23538

327009 Sunward Park Clinic Eric Klug South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157327005 Vergelegen Medi Clinic Johannes Engelbrecht South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157327001 Morningside Clinic Anthony Becker South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157327008 Union Hospital Tjaart Venter South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157327004 Linksfield Park Clinic Laurence Disler South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157327006 Sunninghill Hospital Eric Klug South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157327003 Unitas Hospital Pieter Blomerus South Africa Pharma Ethics 123 Amcor Road Lyttelton Manor 0157

321004 KARDIOCENTRUM NITRA s.r.o. Marian Hranai SlovakiaNarodny ustav ardcovych a

cievnych choroba.s., Pod Krasnou horkou 1 Bratislava 37 833 48

321004 KARDIOCENTRUM NITRA s.r.o. Marian Hranai SlovakiaEticka komisia Nitrianskeho

samospravneho krajaStefanikova trieda 69 Nitra 949 01

321003

Národný ústav srdcových a cievnych chorôb,a.s., Oddelenie interven?nej

kardiológie

Viliam Fridrich SlovakiaNarodny ustav ardcovych a

cievnych choroba.s., Pod Krasnou horkou 1 Bratislava 37 833 48

321002

Východoslovenský ústav srdcových a cievnych

chorôb,a.s., Kardiologické oddelenie

Martin Studenčan SlovakiaNarodny ustav ardcovych a

cievnych choroba.s., Pod Krasnou horkou 1 Bratislava 37 833 48

321002

Východoslovenský ústav srdcových a cievnych

chorôb,a.s., Kardiologické oddelenie

Martin Studenčan SlovakiaVychodoslovensky ustav

srdcovych a cievnych choroba.s., Trieda SNP 1 Kosice Slovac Republic 040 11

320016Hospital Jihlava and

Cardiocenter Vysocina CZ a.s.Zdenek Klimsa Czech Republic Eticka komise, Nemocnice Jihlava, Vrchlickeho 59 Jihlava 58633

320016Hospital Jihlava and

Cardiocenter Vysocina CZ a.s.Zdenek Klimsa Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 625 00

366004 Songklanagarind Hospital Noppadol Chamnarnphol ThailandEthics Committee Faculty of

Medicine,

Prince of Songkhla University, Songklanagarind Hospital Kranjanavanich

Road, Amper HadyalSongkhla 90110

366003 Phramongkutklao Hospital Nakarin Sansanayudh ThailandRoyal Thai Army Medical

Department - Ethical Review Committee

315 Rajavithi Road Rajathevee Bangkok 10400

366002King Chulalongkorn Memorial

HospitalWacin Buddhari Thailand

King Chulalongkorn Memorial Hospital

Chulalongkorn University 1873 Rama IV Rd. Pathumwan

Bangkok 10330

366001Maharaj Nakorn Chiang Mai

HospitalSrun Kuanprasert Thailand

Chiangmai University, Faculty of Medicine -

Research Ethics CommitteeIntrawaroros Rd., Muang District Chiangmai 50200

359008 SHAT of Cardiology Mladen Grigorov Bulgaria Multi-Site Ethics Committee 26 Yanko Sakazov Blvd Sofia 1504

359007Department of Cardiology,

Tokuda HospitalIvo Petrov Bulgaria Multi-Site Ethics Committee 26 Yanko Sakazov Blvd Sofia 1504

3590032nd Clinic of Cardiology, MHAT

'Sveta Marina'Svetoslav Georgiev Bulgaria Multi-Site Ethics Committee 26 Yanko Sakazov Blvd Sofia 1504

359005Clinic of Invasive Cardilogy, UMHAT "Sveti Georgi" EAD -

PlovdivIvan Manukov Bulgaria

Scientific Ethics Committee at uMHAT Sveti Georgi EAD -

Plovdiv66 Peshtersko Shosse Str. Plovdiv 4002

359002Clinic of Cardiology, UMHAT

'Sv. Anna'Nizaf Rifai Bulgaria

Local Ethics Committee at UMHAT Sveta Anna-Sofia AD

1 Dimitar Mollov Str. Sofia 1709

359004Cardiology Clinic, UNSHAT "St.

Ekatherina"Julia Jorgova Bulgaria

Local Ethics Committee at UNSHAT St. Ekatherina

52A, Pencho Slavelkov Blvd., Sofia 1431

359001Clinic of Cardiology, National

Cardilogy HospitalAlexander Doganov Bulgaria Multi-Site Ethics Committee 26 Yanko Sakazov Blvd Sofia 1504

359001Clinic of Cardiology, National

Cardilogy HospitalAlexander Doganov Bulgaria

Local Ethics Committee at SHATCVD - NCH - EAD

65 Konyovitza Str. Sofia 1309

320001Faculty hospital Kralovské

Vinohrady 3rd Internal Cardiology Clinic

Viktor Kocka Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 62500

320001Faculty hospital Kralovské

Vinohrady 3rd Internal Cardiology Clinic

Viktor Kocka Czech Republic Eticka komise FNKV FN Kralovske Vinohrady Srobarova 50 Praha 10 100 34

The Medicines Company Confidential 10/29/2012 Page 6

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 21: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

320006Hospital Pardubice, Internal

clinic, CardiologyVladimir Rozsival Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 62500

320006Hospital Pardubice, Internal

clinic, CardiologyVladimir Rozsival Czech Republic

Eticka komise pri Pardubicke krajske

nemocnici, a.s.,Kyjevska 44 Pardubice 532 03

3200142nd Internal - Cardiovascular

dpt. Of Municipal Hospital Ostrava

Jan Mrozek Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 62500

3200142nd Internal - Cardiovascular

dpt. Of Municipal Hospital Ostrava

Jan Mrozek Czech RepublicEticka komise Mestske

nemocnice OstravaNemocnicni 20 Ostrava 1 728 80

320002 Vseobecna fakultni nemocnice Stanislav Simek Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 625 00

320002 Vseobecna fakultni nemocnice Stanislav Simek Czech RepublicEticka komise Vseobecne fakultni nemocnice v Praze

Na Bojisti 1 III. patro Praha 2 128 08

320007Hospital Ceske Budejovice Cardiocenter - cardiology

Frantisek Tousek Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 625 00

320007Hospital Ceske Budejovice Cardiocenter - cardiology

Frantisek Tousek Czech RepublicEticka komise Nemocnice

Ceske Budejovice a.s.,B. Nemcove 585/54

Ceske Budejovice

370 87

320003Faculty hospital Brno Internal and Cardiological Department

Petr Kala (None) Eticka komise FN Brno Jihlavska 20 Brno 625 00

320008Faculty Hospital U sv. Anny

Brno, 1st Internal - Cardioangiological Dpt.

Ladislav Groch (None) Eticka komise FN Brno Jihlavska 20 Brno 625 00

320008Faculty Hospital U sv. Anny

Brno, 1st Internal - Cardioangiological Dpt.

Ladislav Groch (None)Eticka komise FN U sv. Anny

v BrnePekarska 53 Brno 656 91

320004

Faculty hospital Hradec Králové, Internal clinic - department of invasive

cardiology

Josef Stasek Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 62500

320004

Faculty hospital Hradec Králové, Internal clinic - department of invasive

cardiology

Josef Stasek Czech RepublicEticka komise FN Hradec

Kralove,Sokolska 581 Hradec Kralove 500 05

320011Bata regional hospital Inc.

internal clinicZdenek Coufal Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 625 00

320011Bata regional hospital Inc.

internal clinicZdenek Coufal Czech Republic

Eticka komise, Krajska nemocnice T. Bati, a.s.,

Havlickovo nabrezi 600 Zlin 762 75

320005

Faculty hospital Ostrava Faculty hospital Ostrava Internal Clinic, Dpt. Of

Invasive Cardiology

Leos Pleva Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 625 00

320005

Faculty hospital Ostrava Faculty hospital Ostrava Internal Clinic, Dpt. Of

Invasive Cardiology

Leos Pleva Czech Republic Eticka komise FN Ostrava, 17, listopadu 1790 Ostrava 708 52

320012Faculty hospital Olomouc, 1st

Internal ClinicMarek Richter (None) Eticka komise FN Brno Jihlavska 20 Brno 625 00

320012Faculty hospital Olomouc, 1st

Internal ClinicMarek Richter (None) Eticka komise FNO a LF UP I.P. Pavlova 6 Olomouc 775 20

320013 Hospital Podlesi, Cardiocenter Marian Branny Czech Republic Eticka komise FN Brno Jihlavska 20 Brno 625 00

320013 Hospital Podlesi, Cardiocenter Marian Branny Czech RepublicEticka komise Nemocnice

PodiesiKardiocentrum Konska 453 Trinec 739 61

391003Apollo Hospitals International

LtdJoshi Hasit India

Apollo Hospitals International Ltd.

Plot No. 1A, Bhat, GIDC Estate Gandhinagar Gujarat 382428

391024QRG Central Hospital and

Research CentreRishi Gupta India

The QRG CHRC Ethics Committee

69, Sector-20A, Near Neelam Flyover Auronda Chowk, Mathura Road

Faridabad Harayana 121001

382001Wonju Christian Hospital, Yonsei University Wonju

College of MedicineSeung-Hwan Lee

Korea, Republic of

Wonju Christian Hospital, Yonsei University

Wonju College of Medicine 162 Ilsan-dong Wonju Gangwon-do 220-701

382002 Korea University Guro Hospital Hong Seog SeoKorea, Republic

ofKorea University Guro

Hospital80 Guro-dong Guro-gu Seoul 152-803

382003Gachon Medical School, Gil

Medical CenterEak-Kyun Shin

Korea, Democratic

People's Republic of

Gachon University Gil Hospital

1198, Guwol-dong Namdong-gu Incheon 405-760

382004 Yeungnam University Hospital Jong-Seon Park

Korea, Democratic

People's Republic of

IRB, Yeungnam University Hospital

317-1 Daemyeong-dong Nam-gu Daegu 705-717

The Medicines Company Confidential 10/29/2012 Page 7

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 22: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

382005National Health Insurance Corporation Ilsan Hospital

Dong-Woon JeonKorea, Republic

ofNational Health Insurance

Corp. Ilsan Hospital1232, Baekseok-dong Ilsandong-gu Koyangcity Koyonggido 410-360

382006Seoul National University

Bundang HospitalIn-Ho Chae

Korea, Democratic

People's Republic of

Seoul National University Bundang Hospital

300 Gumi-dong Bundang-gu Seongnam-si Gyeonggi-do 463-707

382007Chunnam National University

HospitalMyung-ho Jeong

Korea, Democratic

People's Republic of

Chonnam National University Hospital IRB

#8 Hak-dong Dong-gu Gwangju 501-757

382008 Dong-A University Hospital Kwang-Soo Cha

Korea, Democratic

People's Republic of

Dong-A University Hospital 3-1 Ga, Dongdaeshin-dong Seo-gu Busan 602-714

382009Inje University Ilsan Paik

HospitalJoon-Hyung Doh

Korea, Democratic

People's Republic of

Inje University Ilsan Paik Hospital IRB

2240 Daehwa-dong Ilsanseo-gu Goyang-Si Gyeonggi-do 411-706

382010EWHA Womans University

Dongdaemun HospitalWook-Bum Pyun

Korea, Democratic

People's Republic of

Ehwa Women's Univ. Mokdong Hospital

Dept. of Internal Medicine, Division of Cardiology Mok 6-dong, Yangcheon-gu

Seoul 158-710

382011Hallym University Sacred Heart

HospitalChong-Yun Rhim

Korea, Democratic

People's Republic of

Hallym University Sacred Heart Hospital

896 Pyungchon-dong Dongn-gu Anyang-si Gyeonggi-do 431-070

382012Kyungpook National University

HospitalHun-Sik Park

Korea, Democratic

People's Republic of

Kyungpook National University Hospital

50, Samduk-2ga Jung-gu Daegu 700-721

382013Chuncheon Sacred Heart

Hospital, Hallym University Medical Center

Sang-Jin Han

Korea, Democratic

People's Republic of

Chuncheon Sacred Heart Hospital, Hallym University

Med Center153 Kyo-dong Chuncheon Gangwon-do 200-704

382014Keimyung University Dongsan

Medical CenterSeung-Ho Hur

Korea, Democratic

People's Republic of

Keimyung University Dongsan Medical Center

194 Dongsan-dong Jung-gu Daegu 700-712

391001Nizam’s Institute of Medical

SciencesLanka Krishna India

Institutional Ethics Committee, Nizam's

Institute of Medical SciencesPanjagutta Hyderabad Andhra Pradesh 500082

391002All India Institute of Medical

Sciences (Aiims College)Balram Bhargava India

All India Institute of Medical Sciences Ethics Committee

Ansari Nagar New Delhi Delhi 110029

391004Krishna Heart Institute& Super

Speciality HospitalTejas Patel India

Ethics Committee of Krishna Heart Institute

Krishna Heart and Super Specialty Institute, Ghuma

Ahmedabad Gujarat 380058

391005KEM Hospital and Research

CenterGadkari Milind India

KEM Hospital Research Centre

Ethics Committee Sardar Moodliar Road, Rasta Peth

Pune 411011

391007 Bankers Heart Institut Darshan Banker India Bankers Heart InstituteNear Tagorenagar, Opposite Suryakiran

Complex Old Padra RoadVadodara Gujarat 390015

391008Escorts Heart Institute &

Research CenterSuman Bhandari India

Independent EC, Escorts Heart Institute and

Research Centre LimitedOkhla Road New Delhi 110025

391009 Dharma Vira Heart Centre, Ashwani Mehta India Sir Ganga Ram Hospital Ethics Committee Old Rajinder Nagar, New Delhi 110060

391011 Grant Medical Foundation Shirish Hiremath IndiaPoona Medical Research

FoundationThe Ethics Committee 40 Sassoon Road Pune 411011

391012 West Fort Hi-Tech Hospital Ltd Padinhare Mohanan IndiaWest Fort Hi-Tech Hospital

Ltd.Institutional Ethics Committee P.B No-930,

PunkunnamThrissur Kerala 680002

391013 Osmania Hospital Sampath Kumar India Osmania Medical College Koti Hyderabad Andhra Pradesh 500095

391015 S.A.L.Hospital Keyur Parikh IndiaSAL Hospital and Medical

Institute, Ethics CommitteeOpp. Doordarshan, Drive In Road, Ahmedabad Gujarat 380054

391017Jehangir Clinical Development

CentreV.S. Srikanthan India

Hirabai Cowasji Jehangir Medical Research Institute

and Jehangir Clinical Development Center -

Ethics Committee,

Jehangir Hospital Premises, 32, Sassoon Road,

Pune Maharashtra 411001

391018Krishna Heart and Super

Speciality InstituteTejas Patel India

Ethics Committee of Krishna Heart Institute

Krishna Heart and Super Specialty Institute, Ghuma

Ahmedabad Gujarat 380058

391019 Sahyadri Speciality Hospital Gadkari Milind India Sahyadri Speciality Hospital Ethics Committee Plot No. 30C, Erandawane, Pune 411004

The Medicines Company Confidential 10/29/2012 Page 8

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 23: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

391020 Arneja Heart Institute Jaspal Arneja IndiaCentral India Medical

Research EC, Dr. S. M. Patil's Hospital

2nd Floor, Yugdharma Complex Ramdaspeth Nagpur 440010

391022 CHL-Apollo Hospitals Rajesh Jain IndiaCHL-Apollo Hospitals, Ethics

CommitteeA.B. Road, Near L.I.G. Triangle Indore 452008

355002 Casa de Saúde Santa Marcelina Marco Perin BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355002 Casa de Saúde Santa Marcelina Marco Perin BrazilComite de Etica em

Pesquisa - Casa de saude Santa Marcelina

Rua Santa Marcelina n 91 - Bloco A - Itaquera

Sao Paulo 08270-070

355003Fundacao Bahiana de

CardiologiaAntonio Godinho Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355003Fundacao Bahiana de

CardiologiaAntonio Godinho Brazil

Comite de Etica em Pesquisa em Seres

Humanos da Maternidade Climerio de Oliveira/UFBA

Rua Padre Feijo, 240, Amb. Magalhaes Neto, PPgMS, 3 andar

Salvador - BA -

355004 Hospital Espanhol Fabio Vilas-Boas BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355004 Hospital Espanhol Fabio Vilas-Boas Brazil

Comite de Etica em Pesquisa da Real Sociedade

espanhola de Beneficiencia/Hospital

Espanhol

Av. Sete de Setembro, 4161, Barra Salvador - BA 41148-900

355007 Hospital Lucio Rebelo Jose Jatene BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355007 Hospital Lucio Rebelo Jose Jatene Brazil

Comite de Etica em Pesquisa Medica Humana e

Animal do Hospital das Clinicas da uFG

(CEPMHA/HC/UFG).

Rua C-5 - Quadra 28 Lote 01 - Jardim America

Goiania GO CEP: 74265 050

355008 Hospital Geral de Goiânia Vinicius Vaz BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355008 Hospital Geral de Goiânia Vinicius Vaz BrazilComite de Etica e Pesquisa Humana e Animal (CEPHA)

Av. anhanguera, 4379 - Setor Oeste Goiania Go 74043-011

355011 Hospital Felicio Rocho Jamil Saad BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355011 Hospital Felicio Rocho Jamil Saad Brazil

Comite de Etica em Pesquisa em Seres

Humanos do Hospital Felicio Rocho/MG

Rua Timbiras, 3642/803 Belo Horizone MG 30140-062

355013Instituto do Coração do

Triângulo MineiroRoberto Botelho Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355013Instituto do Coração do

Triângulo MineiroRoberto Botelho Brazil

Comite de Etica em Pesquisa da Santa Casa de

Misericordia de Belo Horizonte

Av. Francisco Salles 1.111 - 9 Andar Belo Horizonte MG 30150-221

355016Sociedade Hospitalar Angelina

CaronDalton Precoma Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355016Sociedade Hospitalar Angelina

CaronDalton Precoma Brazil

Comite de Etica em Pesquisa do Hospital

Angelina CaronRodovia do Caqui, 1150

Campina grande do dul

PR 83430-000

355019Instituto de Cardiologia do Rio

Grande do SulIran Castro Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355019Instituto de Cardiologia do Rio

Grande do SulIran Castro Brazil

Comite de Etica em Pesquisa do Instituto de

Cardiologia do Rio Grande do Sul

Av. Princesa Isabel, 370 Porto Alegre RS 90620-000

355023Hospital São Vicente de Paulo -

Passo FundoRogerio Tadeu Tumelero Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355023Hospital São Vicente de Paulo -

Passo FundoRogerio Tadeu Tumelero Brazil

Comite de Etica em Pesquisa da Universidade

de Passo FundoCampu 1, KM 171 - BR 285, Passo Fundo RS 99001-970

The Medicines Company Confidential 10/29/2012 Page 9

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 24: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

355024Instituto de Cardiologia -

Hospital Regional de São JoséArthur Herdy Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355024Instituto de Cardiologia -

Hospital Regional de São JoséArthur Herdy Brazil

Comite de Etica em Pesquisa do Instituto de

Cardiologia de Santa Catrina

Rua Adolfo Donato da Silva - S/N Bairro Praia Comprida

Sao Jose SC 88103-460

355026Faculdade de Medicina da USP

- INCOREulogio Filho Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355026Faculdade de Medicina da USP

- INCOREulogio Filho Brazil

CAPPesq - Comissao de Etica para analise de Projetos de Pesquisa

HCFMUSP

Rua Ovidio Pires de Campos 255 5 andar Cerqueira Cesar

Sao Paulo SP 05403-010

355027Universidade Federal do

Estado de São Paulo - Hospital São Paulo

Valter Lima BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355027Universidade Federal do

Estado de São Paulo - Hospital São Paulo

Valter Lima BrazilComite de etica em

Pesquisa da Universidade Federal de Sao Paulo

R. Botucatu, 572, 1 andar, cj. 14-V Clementino

Sao Paulo SP 04023-061

355028Irmandade Santa Casa de Misericórdia de São Paulo

Roberto Franken BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355028Irmandade Santa Casa de Misericórdia de São Paulo

Roberto Franken Brazil

Comite de Etica em Pesquisa da Irmandade

Santa Casa de Misericordia de Sao Paulo

Rua Santa Isabel, 305 4. Santa Cecilia Sao Paulo SP 01221-010

302012 Royal Alexandra Hospital William Hui CanadaHealth Research Ethics

Board213 Heritage Medical Research Centre

University of AlbertaEdmonton Alberta T6G 2S2

302017 Trillium Health Centre Charles Lazzam CanadaOptimum Clinical Research

Inc.231 King St East Oshawa Ontario L1H 1C5

302025 Hôpital Notre-Dame du CHUM Francois Reeves CanadaComite d'ethique de la

recherche du CHUMEdifice Cooper, Mezzanine 2 3981 boul. St-

LaurentMontreal Quebec H2W 1Y5

354002Instituto Cardiovascular de

Buenos AiresFernando Cura Argentina

Comite de Etica Independiente - Instituto Cardiovascular de Buenos

Aires

Blanco Encalada 1525 Buenos Aires C1428DCO

354003 Sanatorio Junin Alejandro Escudero ArgentinaComite de Etica

Independiente en Investigacion Clinica

Larrea 1381 3 A Buenos Aires Capital Federal C1117ABK

354005 Sanatorio Parque Carlos Poy ArgentinaComite de Etica

Independiente en Investigacion Clinica

Larrea 1381 3 A Buenos Aires Capital Federal C1117ABK

354006 Hospital Ramon Carrillo Miguel Miceli ArgentinaComite de Etica

Independiente en Investigacion Clinica

Larrea 1381 3 A Buenos Aires Capital Federal C1117ABK

354013 Sanatorio de la Trinidad Mitre Antonio Pocovi ArgentinaComite de Etica Dr. Virgillo

G. FogliaTucuman 335 7 D Buenos Aires 1049

354014 Sanatorio Allende Hugo Londero ArgentinaComite Institucional de Etica de Investigacion in

Salud del Sanatorio AllendeAvenida Hipolito Irigoyen 384 Cordoba 5000

354015Instituto Cardiovascular de

CorrientesJorge Badaracco Argentina

Comite de Etica Independiente en

Investigacion ClinicaLarrea 1381 3 A Buenos Aires Capital Federal C1117ABK

375001Republican Research and

Practical Centre "Cardiology" Leonid Polonetsky Belarus

Ethics Committee of the Republican Research and

Practical Centre "Cardiology"110 R. Luxembourg str., Minsk 220036

375002 1-st Minsk City Clinical Hospital Aliaksey Karotkin BelarusEthics Committee of 1-st Minsk City Clinical Hospital

64 Nezavisimosti ave., MinskRepublic of

Belarus220013

375003Gomel Regional Clinical Cardiology Dispensary

Leanid Shubau BelarusEthics Commission of Gomel Regional Clinical Cardiology

Dispensary4 Meditsynskaya str., Gomel

Republic of Belarus

246027

355030 Hospital Meridional Jose Airton BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355030 Hospital Meridional Jose Airton BrazilComite de Etica em Pesquisa Meridional

R. Sao Joao Batista n 200 Meridional Center - Hospital Meridional Trevo de Alto Laje

Cariacica ES Cep: 29156-580

355035 Universidade de Caxias do Sul Eduardo Maffini BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

The Medicines Company Confidential 10/29/2012 Page 10

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 25: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

CHAMPION PLATFORM: PI and IRB/EC Listing

Site Number Site Name PI Name Country IRB Name Address City State Zip

355035 Universidade de Caxias do Sul Eduardo Maffini Brazil

Comite de Etica em Pesquisa - Fundacao

Universidade de Caxias do Sul

Francisco Getulio Vargas, 1130 Bloco A Caxias do Sul RS -

355036Hospital de Clinicas de Porto

AlegreCarisi Polanczyk Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355036Hospital de Clinicas de Porto

AlegreCarisi Polanczyk Brazil

Comite de Etica em Pesquisa do Hospital de Clinicas de Porto Alegre -

HCPA

Rua Ramiro Barcelos no. 2350 Santana Porto Alegre RS 90035-903

355037Centro Integrado de Atenção à

SaúdeBruno Machado Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355037Centro Integrado de Atenção à

SaúdeBruno Machado Brazil

Comite de Etica em Pesquisa em Seres Humanos do Centro

Integrado de Atencao e Saude - CIAS

av. Leitao da Silva, 2311 - Otarare Vitoria - ES 29047 - 575

355038 Hospital Bandeirantes Helio Castello Junior BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355038 Hospital Bandeirantes Helio Castello Junior BrazilComite de Etica em

Pesquisa da Sociedade Assistencial Bandeirantes

Rua Galvao Bueno, 257 - 5 andar Sao Paulo SP Cep: 01506-000

355039 Hospital São Lucas - RS Paulo Ricardo Caramori BrazilComissao Nacional de Etica

em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-

B Brasilia - DF

Cep: 70.058-900

355039 Hospital São Lucas - RS Paulo Ricardo Caramori BrazilComite de Etica em Pesquisa da PUCRS

Av. Ipiranga, 6690 3 Andar Porto Alegre RS 90610

395002 Emergency Cardiology Centre Gulnara Chapidze GeorgiaEC of Emergency cardiology centre by Academician G.

Chapidze4, Lubliana Street, Tbilisi 0159

395003Clinic of Angiocardiology

“ADAPTI”Merab Mamatsashvili Georgia

Ethics Committee of Clinic of Angiocardiology "ADAPTI"

16, Kavtaradze str., Tbilisi 0186

395004Tbilisi State Medical University

Alexandre Aladashvili University Clinic

Irakli Khintibidze Georgia

Ethics Committee of Tbilisi State Medical University

Alexandre Aladashvili University Clinic

103, D Uznadze str. Tbilisi 0102

370001Kaunas Medical University

Hospital, Cardiology Department

Dr. Grinius LithuaniaLithuania Bioethics

CommitteeDidzioji str. 22 Vilnius LT-01128

370002Klaipeda Seamen's Hospital, 3rd Cardiology Department

Sigute Norkiene LithuaniaLithuania Bioethics

CommitteeDidzioji str. 22 Vilnius LT-01128

370003Vilnius University Hospital

“Santariskiu Klinikos", Centre of Cardiology and Angiology

Birute Petrauskiene LithuaniaLithuania Bioethics

CommitteeDidzioji str. 22 Vilnius LT-01128

364001 Auckland Harvey White New ZealandMulti Region Ethics

Committee c/o Ministry of Health

P.0. Box 5013 Wellington -

364002 Waikato Gerard Devlin New ZealandMulti Region Ethics

Committee c/o Ministry of Health

P.0. Box 5013 Wellington -

364007 Wakefield Malcolm Abernethey New ZealandMulti Region Ethics

Committee c/o Ministry of Health

P.0. Box 5013 Wellington -

The Medicines Company Confidential 10/29/2012 Page 11

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 26: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

SiteNumber Site Name PIName Country IRB Name Address City State Zip

443002 AKH Linz Franz Leisch AustriaMA 15- Gesundheitsdienst der Stadt Wien Ethikkommission der Stadt Wien Thomas Klestil Platz 8 Town Town 1.Stock CB 12. 103 Wien 1030

443004 Wilhelminenspital der Stadt Wien Kurt Huber AustriaMA 15- Gesundheitsdienst der Stadt Wien Ethikkommission der Stadt Wien Thomas Klestil Platz 8 Town Town 1.Stock CB 12. 103 Wien 1030

443005 Landeskrankenhaus Feldkirch Werner Benzer AustriaMA 15- Gesundheitsdienst der Stadt Wien Ethikkommission der Stadt Wien Thomas Klestil Platz 8 Town Town 1.Stock CB 12. 103 Wien 1030

455002 Hospital Felicio Rocho Jamil Abdalla Saad BrazilComissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-B Brasilia - DF

Cep: 70.058-900

455002 Hospital Felicio Rocho Jamil Abdalla Saad Brazilcomite de Etica em Pesquisa do Hospital Felicio Rocho Av do Contorno, 9530 - Barro Preto Belo Horizonte MG/Brasil CEP 30110-934

455005Instituto do Coracao do Triangulo Mineiro Roberto Vieira Botelho Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-B Brasilia - DF

Cep: 70.058-900

455005Instituto do Coracao do Triangulo Mineiro Roberto Vieira Botelho Brazil

Comite de Etica em Pesquisa da Universidade Federal de Uberlandia

Avenida Joao Naves de Avila, 2121, sala 224 - bloco 1A Uberlandia Minas Gerais

CEP: 38408-100

455009Loema - Instituto de Pesquisa Clinica & Consultores Fabio Rossi Dos Santos Brazil

Comite de Etica em Pesquisa em Seres Humanos da Irmandade de Misericordia de Campinas

Hospital Irmaos Penteado Avenida Benjamin Constant, 1657 - Centro Campinas Sao Paulo CEP 13010-142

455009Loema - Instituto de Pesquisa Clinica & Consultores Fabio Rossi Dos Santos Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-B Brasilia - DF

Cep: 70.058-900

455016Instituto Dante Pazzanese de Cardiologia Alexandre Abizaid Brazil

Comite de Etica em Pesquisa do Instituto Dante Pazzanese de Cardiologia

Av. Dr. Dante Pazzanese, 500 6. andar, Torre - Ibirapuera Sao Paulo 04012-909

455017 Hospital São JoséCarlos Augusto Formiga Areas Brazil

Comissao Nacional de Etica em Pesquisa (CONEP)

Ministerio da Saude - Esplanada dos Ministerios Edificio Anexo Bl. G Ala B SI. 13-B Brasilia - DF

Cep: 70.058-900

455017 Hospital São JoséCarlos Augusto Formiga Areas Brazil

Comite de Etica em Pesquisa em Seres Humanos do Hospital Universitario Sao Jose

Ezequiel Dias, 275 - Quinto andar- Santa Efigenia Belo Horizonte Minas Gerias Brasil CEP 30130-110

459002 MHAT 'Tokuda Hospital Sofia', AD Ivo Petrov Bulgaria Ethics Committee for Multicenter Trials 8, Damyan Gruev Str. Sofia 1303459003 SHATC - Varna, EOOD Nikolay Penkov Bulgaria Ethics Committee for Multicenter Trials 8, Damyan Gruev Str. Sofia 1303459005 MHAT 'Sveti Vrach' EOOD Boris Zehirov Bulgaria Ethics Committee for Multicenter Trials 8, Damyan Gruev Str. Sofia 1303459007 Second MHAT - Sofia AD Georgi Grigorov Bulgaria Ethics Committee for Multicenter Trials 8, Damyan Gruev Str. Sofia 1303459010 MHAT 'Dr. Hristo Stambolski' EOOD Boicho Boichev Bulgaria Ethics Committee for Multicenter Trials 8, Damyan Gruev Str. Sofia 1303459011 MHAT 'Puls' AD Borislav Atzev Bulgaria Ethics Committee for Multicenter Trials 8, Damyan Gruev Str. Sofia 1303420001 Vseobecna fakultni nemocnice Stanislav Simek Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00

420001 Vseobecna fakultni nemocnice Stanislav Simek Czech RepublicEticka komise Vseobecne fakultni nemocnice v Praze Na Bojisti 1 III. patro Praha 2 128 08

420002 Fakultni nemocnice Hradec Kralove Josef Stasek Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00420002 Fakultni nemocnice Hradec Kralove Josef Stasek Czech Republic Eticka komise FN Hradec Kralove, Sokolska 581 Hradec Kralove 500 05

420003Fakultni nemocnice Kralovske Vinohrady Viktor Kocka Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00

420003Fakultni nemocnice Kralovske Vinohrady Viktor Kocka Czech Republic Eticka komise FNKV FN Kralovske Vinohrady Srobarova 50 Praha 10 100 34

420004 Fakultni nemocnice v Motole Petr Hajek Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00

420004 Fakultni nemocnice v Motole Petr Hajek Czech RepublicEticka komise pro multicentricke klinicke hodnoceni Fakultni nemocnice v Motole V Uvalu 84 Praha 5 150 06

420005 Fakultni nemocnice Brno Petr Kala Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00420007 Krajska nemocnice T.Bati, a.s. Zdenek Coufal Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00

420007 Krajska nemocnice T.Bati, a.s. Zdenek Coufal Czech Republic Eticka komise, Krajska nemocnice T. Bati, a.s., Havlickovo nabrezi 600 Zlin 762 75420008 Mestska nemocnice Ostrava Jan Mrozek Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00420008 Mestska nemocnice Ostrava Jan Mrozek Czech Republic Eticka komise Mestske nemocnice Ostrava Nemocnicni 20 Ostrava 728 80420009 Nemocnice Ceske Budejovice, a.s. Frantisek Tousek Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00

420009 Nemocnice Ceske Budejovice, a.s. Frantisek Tousek Czech RepublicEticka komise Nemocnice Ceske Budejovice a.s., B. Nemcove 585/54

CeskeBudejovice 370 87

420010 Fakultni nemocnice u sv. Anny v Brne Jan Sitar Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00

Phoenix Master Site IRB and EC Listing

The Medicines Company March 7, 2013 Page 1

Page 3572Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 27: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

SiteNumber Site Name PIName Country IRB Name Address City State Zip

Phoenix Master Site IRB and EC Listing

420010 Fakultni nemocnice u sv. Anny v Brne Jan Sitar Czech Republic Eticka komise FN U sv. Anny v Brne Pekarska 53 Brno 656 91

420011Krajska zdravotni, a.s. - Masarykova nemocnice Usti nad Labem, o.z. Pavel Cervinka Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00

420011Krajska zdravotni, a.s. - Masarykova nemocnice Usti nad Labem, o.z. Pavel Cervinka Czech Republic

Eticka komise Krajske zdravotni, a.s., Masarykovy nemocnice, o.z. Socialni pece 3316/12A Usti nad Labem 401 13

420012 Krajska nemocnice Liberec, a.s. David Horak Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00

420012 Krajska nemocnice Liberec, a.s. David Horak Czech RepublicEticka komise pro multicentricka hodnoceni Krajska nemocnice Liberec, a.s. Husova 10 Liberec 460 63

420013 Nemocnice Na Homolce Petr Kmonicek Czech Republic Multicentricka eticka komise Fakultni nemocnice Brno Jihlavska 20 Brno 625 00420013 Nemocnice Na Homolce Petr Kmonicek Czech Republic Eticka komise Nemocnice Na Homolce Roentgenova 37/2 Praha 5 150 03

495001Emergency Cardiology Center by Academician G.Chapidze LLC Gulnara Chapidze Georgia

EC of Emergency cardiology centre by Academician G. Chapidze 4, Lubliana Street, Tbilisi 0159

495002 Diagnostic Services Clinic LTD George Khabeishvili Georgia Diagnostic Services Clinic Ltd. 33, Chavchavadze avenue, Tbilisi 0179

495003EOPL. Tbilisi State Medical University Alexandre Aladashvili University Clinic Nodar Emukhvari Georgia

Ethics Committee of Tbilisi State Medical University Alexandre Aladashvili University Clinic 103, D Uznadze str. Tbilisi 0102

495004The Clinic of Angiocardiology "ADAPTI" LLC Merab Mamatsashvili Georgia

Ethics Committee of Clinic of Angiocardiology "ADAPTI" 16, Kavtaradze str., Tbilisi 0186

495005 Tbilisi Heart and Vascular Clinic LTD Tamaz Shaburishvili GeorgiaThe Ethics Committee of "Tbilisi Heart and Vascular Clinic" LTD 9 Tsinandali street Tbilisi 0144

449001Universitaetsklinikum Schleswig-Holstein Peter Radke Germany Universitat zu Lubeck

Medzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449002 St. Johannes Hospital - PS Hubertus Heuer Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449003Universitätsmedizin der Johannes Gutenberg-Universität Mainz Sabine Genth-Zotz Germany Universitat zu Lubeck

Medzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449004 Vivantes-Humboldt Klinikum Martin Dissmann Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449005 Vivantes Klinikum im Friedrichshain Stefan Hoffmann Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449007 St. Josef-Hospital - PS Andreas Mugge Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449009Universitaetsklinikum Hamburg-Eppendorf Britta Goldmann Germany Universitat zu Lubeck

Medzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449010 Universitaetsklinikum Bonn Nikos Werner GermanyEthikkommission der Medizinischen Fakultat der Universitat Lubek Ratzeburger Allee 160 Lubeck 23538

449012 Universitaetsklinikum Frankfurt Stephan Fichtlscherer Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449013 Vivantes Klinikum Neukoelln Harald Darius Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449014 Vivantes Klinikum Spandau Steffen Behrens Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449016 Klinikum Bielefeld Christoph Stellbrink Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449017 Segeberger Kliniken GmbH Gert Richardt Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449018 Universitaetsklinikum Jena Tudor Poerner Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449019 Klinikum Grosshadern der LMU Wolfgang Franz Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

The Medicines Company March 7, 2013 Page 2

Page 3573Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 28: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

SiteNumber Site Name PIName Country IRB Name Address City State Zip

Phoenix Master Site IRB and EC Listing

449020 Universitaetsklinikum Heidelberg Evangelos Giannitsis GermanyEthikkommission der Medizinischen Fakultat der Universitat Lubek Ratzeburger Allee 160 Lubeck 23538

449021 Universitaetsklinikum Tuebingen Tobias Geisler Germany Universitat zu LubeckMedzinische Faklutat, Ethikkommission Ratzeburfer Allee 160 Lubeck 23538

449022 St. Marienkrankenhaus Siegen Michael Buerke GermanyEthikkommission der Medizinischen Fakultat der Universitat Lubek Ratzeburger Allee 160 Lubeck 23538

439001 Presidio Ospedaliero della Misericordia Andrea Picchi ItalyComitato Etico per ia Sperimentazione dei Farmaci della AUSL 9 di Grosseto Via Genova 6d Grosseto 58100

439002 Ospedali Riuniti di Bergamo Giuseppe Musumeci ItalyComitato BioEtico dell'Azienda Ospedall Riuniti di Bergamo Largo Barozzi, 1 Bergamo 24128

439003Azienda Ospedaliero Universitaria di Parma Alberto Menozzi Italy Comitato Etico Unico Per La Provincia Di Parma Via Gramsci, 14 Parma 43100

439004Fondazione IRCCS Policlinico San Matteo Ezio Bramucci Italy Comitato Etico Azienda Ospedaliera Universiaria "Federico II"

Via Sergio Pansini, 5 Napoli 80131

439006Azienda Ospedaliera Universitaria "Federico II" Gennaro Galasso Italy Comitato Etico Azienda Ospedaliera Universiaria "Federico II"

Via Sergio Pansini, 5 Napoli 80131

439008 Ospedale Civile di Legnano Stefano De Servi ItalyComitato Etico dell'Azienda Ospedaliera Ospedale Civile di Legnano Via Candiani, 2 Legnano MI 20025

439009 Istituto Clinico Humanitas Patrizia Presbitero Italy Comitato Etico Instituto Clinico Humanitas Via Manzoni, 56 Rozzano (MI) 20089

464001 Auckland City Hospital Ralph Stewart New ZealandMulti Region Ethics Committee c/o Ministry of Health P.0. Box 5013 Wellington -

464001 Auckland City Hospital Ralph Stewart New Zealand

Northern A Health and Disability Ethics Committee, Health and Disability Ethics Committees, Ministry of Health No 1 The Terrace PO Box 5013 Wellington (04) 8162053

464002 Waikato Hospital Gerard Devlin New ZealandMulti Region Ethics Committee c/o Ministry of Health P.0. Box 5013 Wellington -

464002 Waikato Hospital Gerard Devlin New Zealand

Northern A Health and Disability Ethics Committee, Health and Disability Ethics Committees, Ministry of Health No 1 The Terrace PO Box 5013 Wellington (04) 8162053

464003 Wellington Hospital Alexander Sasse New ZealandMulti Region Ethics Committee c/o Ministry of Health P.0. Box 5013 Wellington -

464003 Wellington Hospital Alexander Sasse New Zealand

Northern A Health and Disability Ethics Committee, Health and Disability Ethics Committees, Ministry of Health No 1 The Terrace PO Box 5013 Wellington (04) 8162053

464006 Middlemore Hospital Douglas Scott New ZealandMulti Region Ethics Committee c/o Ministry of Health P.0. Box 5013 Wellington -

464006 Middlemore Hospital Douglas Scott New Zealand

Northern A Health and Disability Ethics Committee, Health and Disability Ethics Committees, Ministry of Health No 1 The Terrace PO Box 5013 Wellington (04) 8162053

448001SPZOZ Krakowski Szpital Specjalistyczny im.Jana Pawla II Jaroslaw Trebacz Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448002SP Szpital Wojewodzki im.Papieza Jana Pawla II Andrzej Kleinrok Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448004Wojewodzki Specjalistyczny Szpital im.dr W.Bieganskiego Jaroslaw Kasprzak Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448006SPSK Nr 7 UM w Katowicach Gornosl CM prof L Gieca Zbigniew Gasior Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448008SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

Zdzislawa Kornacewicz-Jach Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448010

Instytut Kardiologii im.Prymasa Tysiaclecia St. Kardynala Wyszynskiego Cezary Sosnowski Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448012 Uniwersyteckie Centrum Kliniczne Andrzej Rynkiewicz PolandTerenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

The Medicines Company March 7, 2013 Page 3

Page 3574Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 29: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

SiteNumber Site Name PIName Country IRB Name Address City State Zip

Phoenix Master Site IRB and EC Listing

448013NZOZ Pomorskie Centra Kardiologiczne SA Radoslaw Targonski Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448014

Instytut Kardiologii im.Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego Adam Witkowski Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448015NZOZ Pomorskie Centra Kardiologiczne SA Witold Dubaniewicz Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448016Szpital Wojewodzki im. M. Kopernika w Koszalinie Elzbieta Zinka Poland

Terenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

448019 NZOZ Centrum Medyczne HCP Szyszka Andrzej PolandTerenowa Komisja Bioetyczna przy Instytucie Kardiologii ul. Alpejska 42 Warszawa 04-628

407001

FSBI Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov of the MoH and Social Dev Alexey Yakovlev

RussianFederation

Ethics Committee of FederalState Budget Institution Federal Center of Heart, Blood and Endocrinology 3, Rahmanovskij pereulok Moscow 194156

407001

FSBI Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov of the MoH and Social Dev Alexey Yakovlev

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407002

Regional State Budget Healthcare Institution, Regional Clinical Hospital #1 Krasnoyarsk Kirill Linev

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407002

Regional State Budget Healthcare Institution, Regional Clinical Hospital #1 Krasnoyarsk Kirill Linev

RussianFederation

Local Ethics Committee of Regional State Budget Healthcare Institution Regional Clinical Hospital 3A, Partizana Zheleznyaka Str Krasnoyarsk 660022

407003Moscow State Healthcare Institution, City Clinical Hospital #81 Zaur Shogenov

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407003Moscow State Healthcare Institution, City Clinical Hospital #81 Zaur Shogenov

RussianFederation

Local Ethics Committee of Moscow State Healthcare Institution City Clinic Hospital No. 81 10, Lobnenskaya ul Moscow 127644

407004

State Healthcare Institution, Regional Clinical Hospital #1 n.a. Prof. S.V. Ochapovsky Elena Kosmachova

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407004

State Healthcare Institution, Regional Clinical Hospital #1 n.a. Prof. S.V. Ochapovsky Elena Kosmachova

RussianFederation

Local Ethics Committee of State Healthcare Institution Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovskiy 167, 1 Maya ul Krasnodar 350086

407005Research Institure of Cardiology SB RAMS Valentin Markov

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407005Research Institure of Cardiology SB RAMS Valentin Markov

RussianFederation

Biomedical Ethics Committee of Institution of the Russian Academy of Medical Sciences Research Institute of Cardiology of Siberian Branch of the Russi 111a, Kievskaya str Tomsk 634012

407006Ural State Medical Academy, Sverdlovsk Regional Clinical Svetlana Kalinina

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407006Ural State Medical Academy, Sverdlovsk Regional Clinical Svetlana Kalinina

RussianFederation

Ethics Committee attached to Sverdlovsk Regional State Budget Healthcare Institution "Scientific and Practical Center of Specialized Medical Care" 78A, 8 Marta Str Ekaterinburg 620144

The Medicines Company March 7, 2013 Page 4

Page 3575Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 30: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

SiteNumber Site Name PIName Country IRB Name Address City State Zip

Phoenix Master Site IRB and EC Listing

407007Municipal Healthcare Institution Kemerovo Cardiology Dispensary Olga Barbarash

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407007Municipal Healthcare Institution Kemerovo Cardiology Dispensary Olga Barbarash

RussianFederation

United Local Ethics Committee of MHI "Kemerovo Cardiology Dispensary" and IRAMS Scientific Research Institute of Cardiovascular Diseases Complex Probl 6, Sosnovy bulvar Kemerovo 650002

407008State Clinical Hospital #23 MedSanTrud Elena Vasilieva

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407008State Clinical Hospital #23 MedSanTrud Elena Vasilieva

RussianFederation

Independent Ethics Committee of Moscow State Healthcare Institution Order of Labor Red Banner City Clinical Hospital No. 23 n.a. MedSan Trud 11, Yauzskaya str Moscow 109240

407009City Clinical Hospital #15 n.a. O.M. Filatov Ivan Gordeev

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407009City Clinical Hospital #15 n.a. O.M. Filatov Ivan Gordeev

RussianFederation

Independent Ethics Committee of Moscow State Healthcare Institution City Hospital No. 15 n.a. O.M. Filatov 23, Veshnyakovskaya str Moscow 111539

407010

State-financed Scientific Institution of Tymen Region, Tyumen division of South Ural Scientific Cent Sergey Shalaev

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407010

State-financed Scientific Institution of Tymen Region, Tyumen division of South Ural Scientific Cent Sergey Shalaev

RussianFederation

Ethics Committee attached to State-financed Institution of Tyumen region, Tyumen division of South Ural Scientific Center at Russian Academy of Medica 7, 4th km Chervishevskogo trakta str Tyumen 625000

407012

FSI Saratov Scientific Research Institute of Cardiology of Russian Federation MOH & Social Developme Yakov Dovgalevsky

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407012

FSI Saratov Scientific Research Institute of Cardiology of Russian Federation MOH & Social Developme Yakov Dovgalevsky

RussianFederation

Ethics Committee attached to Federal State Institution Saratov Scientific Reserach Institute of Cardiology of Russian Federation Ministry of Health an 141, Chernyshevskogo ul Saratov 410028

407013

Institution of Khanty-Mansi Autonomous Area - Yugra Regional Clinical Hospital Prokhor Pavlov

RussianFederation

Local Ethics Committee attached to the Institution of Khanty-Mansi Autonomous Area - Yugra Regional Clinical Hospital 40, Kalinina str

Khanty-Mansiysk 628012

407013

Institution of Khanty-Mansi Autonomous Area - Yugra Regional Clinical Hospital Prokhor Pavlov

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

407014State Healthcare Institution Regional Clinical Hospital Irina Sukmanova

RussianFederation

Ministry of Healthcare and Social Development of the Russian Federation, Ethics Council 3, Rahmanovskij pereulok Moscow 127994

The Medicines Company March 7, 2013 Page 5

Page 3576Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 31: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

SiteNumber Site Name PIName Country IRB Name Address City State Zip

Phoenix Master Site IRB and EC Listing

407014State Healthcare Institution Regional Clinical Hospital Irina Sukmanova

RussianFederation

Ethics Committee of Regional State Budget Healthcare Institution Regional Clinical Hospital 1, Lyapidevskogo str Barnaul 656024

466001 Maharaj Nakorn Chiang Mai Hospital Srun Kuanprasert ThailandResearch Ethics Committee, Faculty of Medicine, Chaing Mai University 110 Intavaroros Road, Muang Chaing Mai 50200

466002 Maharat Nakhon Ratchasima Hospital Pinij Kaewsuwanna Thailand

Ethics Committee, Institute for the Development of Human Research Protection (IHRP)

Department of Medical Science, Ministry of Public Health, Tiwanond Road, District Muang Nonthaburi 11000

466002 Maharat Nakhon Ratchasima Hospital Pinij Kaewsuwanna ThailandInstitutional Review Board, Maharat Nakhon Ratchasima Hospital 49 Changpuek Road, Muang District

Nakhonratchasima 30000

466003 Ramathibodi HospitalSaranaBoonbaichaiyapruck Thailand

Ethical Clearance Committee on Human Rights Related to Research Involving Human Subjects

Faculty of Medicine, Ramathibodi Hospital, Mahidol University 270 Rama VI Rd Bangkok 10400

466004 Thammasat University Hospital Dilok Piyayotai Thailand

Ethics Committee, Institute for the Development of Human Research Protection (IHRP)

Department of Medical Science, Ministry of Public Health, Tiwanond Road, District Muang Nonthaburi 11000

466004 Thammasat University Hospital Dilok Piyayotai ThailandEthics Committee, Faculty of Medicine, Thammasat University 95 Moo 8 Klongnuang Sub-District Klongnuang District Pathumthani 12120

466005 Songklanagarind Hospital Noppadol Chamnarnphol Thailand Ethics Committee Faculty of Medicine,Prince of Songkhla University, Songklanagarind Hospital Kranjanavanich Road, Amper Hadyal Songkhla 90110

401001 AnMed Health Brent McLaurin United States Andmed Health IRB 800 North Fant Street Anderson SC 29621

401002 Stony Brook University Medical Center Luis Gruberg United States Chesapeake Research Review, Inc 7063 Columbia Gateway Drive Ste 110 Columbia MD 21046

401003 University of Tennesee Medical Center J. Christopher Scott United States Crescent City Institutional Review Board 2820 Canal Street New Orleans LA 70119

401004Virginia Commonwealth University & VCU Medical Center Evelyne Goudreau United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401007 Vassar Brothers Medical Center Zubair Jafar United StatesVassar Brothers Medical Center Institutional Review Board 45 Reade Place Poughkeepsie NY 12601

401008Amarillo Heart Clinical Research Institute, Inc Ernesto Rivera United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401009 Dallas VA Medical Center Emmanouil Brilakis United States Dallas VAMC Insittutional Review BoardResearch Building 43, Mail Code 151 4500 S. Lancaster Road Dallas TX 75216

401010 Presbyterian Hospital Robert Iwaoka United States Presbyterian Healthcare IRB 200 Hawthorne Lane PO Box 33549 Charlotte NC 28233-3549401011 Geisinger Medical Center James Blankenship United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401012 Moses H. Cone Memorial Hospital Thomas Stuckey United StatesMoses H. Cone Memorial Hospital Insitutional Review Board 1200 North Elm Street Greensboro NC 27401

401013 UVA Health System Lawrence Gimple United StatesUniversity of Virginia Institutional Review Board for Health Sciences Research One Morton Drive Suite 400, Box 5 Charlottesville VA 22903

401014 Hackensack University Medical Center Virender Sethi United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401015Mother Frances Hospital Regional Health Care Center Brent Davis United States Mother Frances Hospital IRB 820 S. Beckham Tyler TX 75701

401016 University of Oklahoma Jorge Saucedo United States OUHSC Institutional Review Board 1000 Stanton L Young Blvd, LIB 176 Oklahoma City OK 73190401017 Heart Hospital of Austin Mark Picone United States Austin Multi-Institutional Review Board PO Box 27782 Austin TX 78755-7782401018 The Chattanooga Heart Institute Brian Negus United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401019 Jesse Brown VA Mladen Vidovich United States Office for the Protection of Research Subjects1737 W. Pollk Street, M/C 672 203 Administrative Office Building Chicago IL 60612

401020 William Beaumont Hospital Amir Abbas United StatesWilliam Beautmont Hospital, Human Investigation Committee 3811 West 13 Mile Road Royal Oak MI 48073

401021 Good Samaritan Hospital Dogan Temizer United States TriHealth IRB, Good Samaritan Hospital Hatton Institute Level 11 Unit J 375 Dixmyth Avenue Cincinnati OH 45220

The Medicines Company March 7, 2013 Page 6

Page 3577Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 32: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

SiteNumber Site Name PIName Country IRB Name Address City State Zip

Phoenix Master Site IRB and EC Listing

401022 University of Illinois at Chicago Adhir Shroff United States Office for the Protection of Research Subjects1737 W. Pollk Street, M/C 672 203 Administrative Office Building Chicago IL 60612

401023 Black Hills Cardiovascular Research Norman Ferrier United States Regional Health IRB 353 Fairmont Blvd Rapid City SD 57701

401024University of Florida Health Science Center Dominick Angiolillo United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401025 Emory University Hospital John Douglas United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401027 Saint Joseph’s Hospital of Atlanta, Inc. Michael Lipsitt United StatesSaint Joseph's Hospital of Atlanta Institutional Review Board 5673 Peachtree Dunwoody Road Suite 650 Atlanta GA 30342

401028 Redmond Regional Medical Center Hector Picon United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010401029 Florida Hospital Arsenio Rodriguez United States Florida Hospital Institutional Review Board 212 E. Winter Park Street Orlando FL 32804

401030Clearwater Cardiovascular and Interventional Consultants Douglas Spriggs United States BayCare Health Systems Pasco-Pinellas IRB 207 Jeffords Street MS #143 Clearwater FL 33756

401032 Emory University Hospital Midtown Chandanreddy Devireddy United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010401037 King's Daughters Medical Center Richard Paulus United States King's DAughters Medical Center IRB #1 2201 Lexington Avenue Ashlabd KY 41101401045 St. Vincent Medical Group James Hermiller United States St. Vincent Institutional Review Board 8402 Harcourt Road Suite 120 Indianapolis IN 46260401046 University of Cincinnati Imran Arif United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401048 Fletcher Allen Health Care Prospero Gogo United StatesUniversity of Vermont-Research Protections Office

Office of Sponsored Programs 245 South Park, Suite 900 Colchester VT 05446

401050 Gaston Memorial Hospital Dustin Letts United States CaroMont Health Insitutional Review Board 2525 Court Drive, PO Box 1747 Gastonia NC 28053

401051John Muir Medical Center, Concord Campus Paul McWhirter United States John Muir Health IRC 2540 East Street Concord CA 94520

401052 St. Joseph Hospital Michael Chan United States St. Joseph Hospital Institutional Review Board 1100 West Stewart Drive Orange CA 92868401053 Harbor-UCLA Medical Center William French United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010401055 Western Medical Center Santa Ana Harinder Gogia United States Western Medical Center Santa Ana IRB 1001 N. Tustin Ave Santa Ana CA 92705

401057Hope Heart Institute/Overlake Medical Clinics Cardiology James Leggett United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401058 Spokane Cardiology, P.S.C Pierre Leimgruber United States IRB-Spokane 104 W. Fourth Avenue Suite 200W Spokane WA 99204

401059 UC Davis Medical Center Reginald Low United States IRB Administration, UC Davis Medical Center2921 Stockton Blvd. CTSC Building, Suite 1400, Room 1429 Sacramento CA 95817

401067 Boston VA Healthcare System Scott Kinlay United StatesBoston VA Health Care System, Research & Development 11-B 150, S. Huntington Ave. Boston MA 02130

401068 Tufts Medical Center Carey Kimmelstiel United StatesTufts Medical Center/Tufts University Institutional Review Board Office 800 Washington Street Box 817 Boston MA 02111

401069 Scottsdale Healthcare Osborn David Rizik United States Scottsdale Healthcare IRB 9003 E. Shea Blvd Scottsdale AZ 85260401070 Scottsdale Healthcare Shea David Rizik United States Scottsdale Healthcare IRB 9003 E. Shea Blvd Scottsdale AZ 85260401071 eStudy Site, La Mesa William O'Riordan United States Sharp Healthcare Insitutional Review Board 8695 Spectrum Center Boulevard San Diego CA 92123401073 Medical Center of Central Georgia Mark Dorogy United States Mecial Center of Central Georgia IRB 777 Hemlock Street MSC 113 Macon GA 31201

401077 Providence Hospital John Galla United States Providence Hospital Institutional Review Board 6801 Airport Boulevard Mobile AL 36608

401079 Princeton Baptist Medical Center Michael Wilensky United StatesBaptist Health System Human Research Review Board 3201 4th Ave South Birmingham AL 35222

401080 Sharp Memorial Hospital Raghava Gollapudi United States Sharp Healthcare Insitutional Review Board 8695 Spectrum Center Boulevard San Diego CA 92123

401082 University Medical Center Jose Suarez United StatesTexas Tech University Health Sciences Center, Lubbock/Odessa Institutional Review Board 3601 4th Street, MS 8146 Lubbock TX 79430-8146

401084 Tomball Regional Hospital Maged Amine United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010401085 St. David's Round Rock Craig Siegel United States Austin Multi-Institutional Review Board PO Box 27782 Austin TX 78755-7782

The Medicines Company March 7, 2013 Page 7

Page 3578Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 33: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

SiteNumber Site Name PIName Country IRB Name Address City State Zip

Phoenix Master Site IRB and EC Listing

401089 St. Vincent’s East Robert Foster United States St. Vincent's East IRB 50 Medical Park East Drive Birmingham AL 35235401091 National Park Medical Center Jeffrey Tauth United States National Park Medical Center IRB 1910 Malvern Ave Hot Springs AZ 71901401091 National Park Medical Center Jeffrey Tauth United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010401092 Saint Joseph Hospital Jonathan Waltman United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401093Wellmont Holston Valley Medical Center Marc Mayhew United States

Wellmont Holston Valley Medical Center Institutional Review Board 1989 E. Stone Drive, 2nd Floor Kingsport TN 37660

401096 Centra Lynchburg General Hospital Thomas Nygaard United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010401097 Carilion Roanoke Memorial Hospital Ayoub Mirza United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401100 Christiana Care Michael Stillabower United StatesChristina Care IRB, Christina Care Health System 4735 Ogletown-Stanton Road MAP 2, Suite 2114 Newark DE 19713

401101 Peninsula Regional Medical Center Joseph Cinderella United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401103Amarillo Heart Clinical Research Institute, Inc Joaquin Martinez-Arraras United States TTUHSC Amarillo IRB 1400 Wallace Boulevard Amarillo TX 79106

401104University of Massachusetts - Worcester Daniel Fisher United States U of Massachusetts Med Sch #1 or #1 55 Lake Ave N Worchester MA 01655

401106Swedish Medical Center - Cardiovascular Research John Petersen United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401109 Scripps Green Hospital Matthew Price United StatesScripps Health Green Hospital IRB #2 (Human Subjects Committee) 11025 North Torrey Pines Road Suite 200 La Jolla CA 92037

401113 Medical University of SC Daniel Steinberg United StatesOffice of Research, Integrity & Risk Protection, Institutional Review Board

Medical University of South Carolina 165 Cannon Street, PO Box 250587 Charleston SC 29425

401118 St. Luke's Medical Center Richard Heuser United States WIRB 3535 Seventh Ave SW Olympia WA 98502-5010

401120 Henry Ford Hospital Michele Voeltz United States Henry Ford Hospital, Institutional Review Board CFP B-035 2799 West Grand Blvd Detroit MI 48202

The Medicines Company March 7, 2013 Page 8

Page 3579Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

cmanno
Text Box
cmanno
Text Box
© 2016 American Medical Association. All rights reserved.
Page 34: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

© 2016 American Medical Association. All rights reserved.  

eTable 1. Baseline Characteristics in the Propensity Score–Matched Cohorts of the CHAMPION PCI Trial

Propensity Score–Matched Cohort

Category Cangrelor Alone Clopidogrel with Routine GPI

P-value Standardized Differences

(%) (N=665) (N=665)

Gender 0.35 5.27 Male 487/665(73.2) 502/665(75.5) Female 178/665(26.8) 163/665(24.5)

Age (median) 0.78 1.60 ≤ median 349/665(52.5) 344/665(51.7) > median 316/665(47.5) 321/665(48.3)

Weight (median) 0.41 4.60 ≤ median 341/665(51.3) 326/665(49.0) > median 324/665(48.7) 339/665(51.0)

Region 0.13 8.35 US 457/665(68.7) 482/665(72.5) Non-US 208/665(31.3) 183/665(27.5)

Presentation 0.05 Stable Angina 73/665(11.0) 94/665(14.1) 9.37 NSTE-ACS 488/665(73.4) 492/665(74.0) 1.36 STEMI 104/665(15.6) 79/665(11.9) 10.76

Stent type 0.91 0.63 Bare Metal or Balloon-only 230/665(34.6) 228/665(34.3) Any Drug Eluting Stent 435/665(65.4) 437/665(65.7)

Medical History Diabetes Mellitus 176/665(26.5) 170/665(25.6) 0.71 2.05 Prior Thienopyridine Use 169/665(25.4) 163/665(24.5) 0.70 2.08 Prior Stroke or TIA 30/665(4.5) 28/665(4.2) 0.78 1.47 Heart Failure 33/665(5.0) 36/665(5.4) 0.71 1.80 PAD 48/665(7.2) 40/665(6.0) 0.38 4.83

Planned Clopidogrel Loading Dosea

-- --

300 mg 0/665(0.0) 0/665(0.0) 600 mg 665/665(100.0) 665/665(100.0)

Periprocedural Medications Bivalirudin 79/665(11.9) 64/665(9.6) 0.18 7.43 Heparin 616/665(92.6) 621/665(93.4) 0.59 3.14

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

Page 35: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

© 2016 American Medical Association. All rights reserved.  

Values are n (%) or n/N (%). Baseline characteristics describe patients included in the modified intention-to-treat cohort of the CHAMPION PCI trial. Denominators exclude patients in whom the status was reported as unknown by the study center. a Percentage of patients receiving each clopidogrel loading dose is based on the planned or intended use declared at the time of stratification. Abbreviations: GPI = glycoprotein IIb/IIIa inhibitors; NSTE-ACS = non-ST-segment elevation acute coronary syndrome; PAD = peripheral artery disease; STEMI = ST-segment elevation myocardial infarction; TIA = transient ischemic attack; US = United States.

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

Page 36: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

© 2016 American Medical Association. All rights reserved.  

eTable 2. Efficacy and Safety Endpoints at 48 Hours After Randomization in Original and Propensity Score–Matched Cohorts of the CHAMPION PCI Trial

Original Cohort Propensity Score–Matched Cohort

Endpoint Cangrelor Alone

Clopidogrel with Routine

GPI

OR (95% CI) P-value

Cangrelor Alone

Clopidogrel with Routine

GPI

OR (95% CI) P-value

Efficacy (N=3193) (N=1008) (N=665) (N=665)

Composite Death/MI/IDR/ST 106(3.3) 32(3.2) 1.05(0.70,1.57) 0.82 21(3.2) 24(3.6) 0.88(0.49,1.57) 0.66

Death 7(0.2) 2(0.2) 1.11(0.23,5.33) 0.90 0(0.0) 1(0.2) -- -- MI 92(2.9) 24(2.4) 1.22(0.77,1.92) 0.40 19(2.9) 18(2.7) 1.06(0.55,2.01) 0.87 IDR 9(0.3) 7(0.7) 0.40(0.15,1.09) 0.07 2(0.3) 6(0.9) 0.33(0.07,1.65) 0.18 ST 4(0.1) 4(0.4) 0.31(0.08,1.26) 0.10 1(0.2) 4(0.6) 0.25(0.03,2.24) 0.22

Safety (N=3219) (N=1022) (N=665) (N=665)

GUSTO-Defined Bleeding Severe 6(0.2) 5(0.5) 0.38(0.12,1.25) 0.11 2(0.3) 4(0.6) 0.50(0.09,2.73) 0.42 Moderate 22(0.7) 16(1.6) 0.43(0.23,0.83) 0.01 8(1.2) 13(2.0) 0.62(0.26,1.48) 0.28 Moderate or Severe 28(0.9) 21(2.1) 0.42(0.24,0.74) 0.003 10(1.5) 17(2.6) 0.59(0.27,1.28) 0.18

TIMI-Defined Bleeding Major 4(0.1) 9(0.9) 0.14(0.04,0.46) 0.001 2(0.3) 8(1.2) 0.25(0.05,1.18) 0.08 Minor 23(0.7) 16(1.6) 0.45(0.24,0.86) 0.02 5(0.8) 12(1.8) 0.42(0.15,1.18) 0.10

Minor or Major 27(0.8) 25(2.4) 0.34(0.19,0.58) <0.001 7(1.1) 20(3.0) 0.35(0.15,0.83) 0.02 ACUITY-Defined Bleeding

Major 95(3.0) 52(5.1) 0.57(0.40,0.80) 0.001 24(3.6) 40(6.0) 0.59(0.35,0.99) 0.04 Minor 484(15.0) 263(25.7) 0.51(0.43,0.61) <0.001 103(15.5) 188(28.3) 0.48(0.37,0.63) <0.001

Any Blood Transfusion 26(0.8) 20(2.0) 0.41(0.23,0.73) 0.003 9(1.4) 16(2.4) 0.56(0.25,1.27) 0.17 Efficacy and Safety: Net Adverse Clinical Events

(N=3193) (N=1008) (N=665) (N=665)

Death/MI/IDR/ST/GUSTO-Defined Bleeding (Severe)

112(3.5) 36(3.6) 0.98(0.67,1.44) 0.92 23(3.5) 27(4.1) 0.85(0.49,1.49) 0.57

Death/MI/IDR/ST/GUSTO-Defined Bleeding (Moderate or Severe)

130(4.1) 50(5.0) 0.81(0.58,1.14) 0.23 30(4.5) 39(5.9) 0.76(0.46,1.24) 0.27

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020

Page 37: Supplementary Online Content · 1200 North Elm Street Greensboro NC 27401 001066 California Pacific Medical Center Peter Hui United States California Pacific Medical Center, Institutional

© 2016 American Medical Association. All rights reserved.  

Figures are expressed as number / total number (rate) from the CHAMPION PCI trial. The efficacy endpoints were assessed in patients included in the modified intention-to-treat population (which comprised patients who underwent percutaneous coronary intervention and received the study drug). The safety endpoints were assessed in patients who underwent randomization and received at least one dose of the study drug. A patient who did not complete the scheduled follow-up and experienced no event was not counted in the denominator. Abbreviations: ACUITY = Acute Catheterization and Urgent Intervention Triage Strategy; CI = confidence interval; GPI = glycoprotein IIb/IIIa inhibitors; GUSTO = Global Use of Strategies to Open Occluded Coronary Arteries; IDR = ischemia-driven revascularization; MI = myocardial infarction; OR = odds ratio; ST = stent thrombosis; TIMI = Thrombolysis in Myocardial Infarction.

Downloaded From: https://jamanetwork.com/ by a Non-Human Traffic (NHT) User on 04/18/2020