The Dual Antiplatelet Therapy Study (DAPT Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis Corporation
Eli Lilly and Company
Daiichi Sankyo Inc.
Medtronic
Information provided by (Responsible Party):
Harvard Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT00977938
First received: September 14, 2009
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.


Condition Intervention Phase
Coronary Artery Disease
Drug: Placebo & Aspirin
Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions

Resource links provided by NLM:


Further study details as provided by Harvard Clinical Research Institute:

Primary Outcome Measures:
  • Incidence of composite of all death, myocardial infarction (MI) and stroke (defined as MACCE) [ Time Frame: 18 months (12-30 months post-index procedure) ] [ Designated as safety issue: No ]
  • Incidence of stent thrombosis (ST) [ Time Frame: 18 months (12-30 months post-index procedure) ] [ Designated as safety issue: No ]
  • Incidence of major bleeding [ Time Frame: 18 months (12-30 months post-index procedure) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20645
Study Start Date: October 2009
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 12m DAPT Study Arm
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.
Drug: Placebo & Aspirin
Active Comparator: 30m DAPT Study Arm
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine treatment in addition to aspirin.
Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin

Detailed Description:

Subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention (PCI) with stent placement and no contraindications to prolonged dual antiplatelet therapy are eligible to be enrolled in the study.

All enrolled subjects will undergo PCI with stent placement. All enrolled subjects will be treated with either an FDA-approved drug eluting stent(s) (DES) or an FDA-approved bare metal stent(s) (BMS) (per their respective Instructions for Use) and assigned to 12 months of open label FDA-approved thienopyridine treatment in addition to aspirin. Operators will select the thienopyridine according to the package insert. Thienopyridine treatment dose will be according to the standard of practice and prescribing information for the selected medication. Aspirin treatment will be 75-325 mg for the first 6 months after the procedure and 75-162 mg subsequently, to be continued indefinitely. All DES or BMS subjects who are treated with 12 months of dual antiplatelet therapy post index procedure and who are event free per protocol will be eligible for randomization to either placebo (12 m DAPT Study arm) or an additional 18 months of thienopyridine treatment (30 m DAPT Study arm). Both arms will continue aspirin therapy.

Up to four (4) separate post-market approval studies will be allowed to incorporate the randomized design of the DAPT Study for a subset of subjects who may then be contributed for the DAPT Study analyses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Enrollment):

  1. Subject is > 18 years of age.
  2. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
  3. Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
  4. The subject has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent will be valid for the duration of the trial or until the subject withdraws.

Inclusion Criterion (Randomization at 12 months):

1. Subject, at 12 months, is free from death, MI, stroke, repeat coronary revascularization, major bleeding, and stent thrombosis and has been compliant with dual antiplatelet therapy following stent implantation.

Exclusion Criteria (Enrollment):

  1. Index procedure stent placement with stent diameter <2.25 mm or >4.0 mm.
  2. Pregnant women.
  3. Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment.
  4. Current medical condition with a life expectancy of less than 3 years.
  5. Concurrent enrollment in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a DES or BMS other than those included as DAPT Study devices. The subject may only be enrolled in the DAPT Study once.
  6. Subjects on warfarin or similar anticoagulant therapy.
  7. Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted.
  8. Subjects unable to give informed consent.
  9. Subject treated with both DES and BMS during the index procedure.

Exclusion Criteria (Randomization at 12 months):

  1. Pregnant women.
  2. Subject switched thienopyridine type or dose within 6 months prior to randomization.
  3. Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
  4. Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
  5. Current medical condition with a life expectancy of less than 3 years.
  6. Subjects on warfarin or similar anticoagulant therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977938

  Hide Study Locations
Locations
United States, Alabama
Thomas Hospital
Fairhope, Alabama, United States, 36532
United States, Arizona
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Heart & Vascular Center of Arizona
Phoenix, Arizona, United States, 85006
Scottsdale Health Care
Scottsdale, Arizona, United States, 85258
United States, Arkansas
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
University of Arkansas (Central VA) for Medical Science
Little Rock, Arkansas, United States, 72205
United States, California
California Cardiovascular Consultants/ Washington Hospital
Fremont, California, United States, 94538
The Foundation for Cardiovascular Medicine
La Jolla, California, United States, 92037
Mercy General Hospital
Sacramento, California, United States, 95819
UC San Diego Medical Center
San Diego, California, United States, 92103-8784
California Pacific Medical Center
San Francisco, California, United States, 94115
St. Joseph's Medical Center- CA
Stockton, California, United States, 95204-6088
Torrance Memorial Medical Center / Vasek Polak Research Program
Torrance, California, United States, 90505
Harbor - UCLA Medical Center
Torrance, California, United States, 90509
United States, Colorado
Medical Center of Aurora
Aurora, Colorado, United States, 80012
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Connecticut Clinical Research, LLC
Bridgeport, Connecticut, United States, 06606
St. Vincent's Medical Center
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Palm Beach Heart Research Institute
Atlantis, Florida, United States, 33462
Bay Area Cardiology Associates/ Brandon Regional Hospital
Brandon, Florida, United States, 33511
Jacksonville Heart Center
Jacksonville, Florida, United States, 32207
Watson Clinic Center for Research
Lakeland, Florida, United States, 33805
Diagnostic Cardiology Associates
Lauderdale Lakes, Florida, United States, 33313
Melbourne Internal Medicine Assoc
Melbourne, Florida, United States, 32901
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Munroe Regional Medical Center
Ocala, Florida, United States, 34471
Ocala Regional Medical Center
Ocala, Florida, United States, 34480
Florida Hospital
Orlando, Florida, United States, 32803
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
Baptist Hospital
Pensacola, Florida, United States, 32501
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
Pepin Heart Hospital
Tampa, Florida, United States, 33613
Winter Haven Hospital
Winter Haven, Florida, United States, 33881
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Piedmont Hospital Research Institute
Atlanta, Georgia, United States, 30309
Emory University Hospital
Atlanta, Georgia, United States, 30322
Medical Center Central Georgia
Macon, Georgia, United States, 31201
Redmond Regional Hospital
Rome, Georgia, United States, 30165
United States, Illinois
Advocate Good Shephard Hospital
Barrington, Illinois, United States, 60010
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Good Samaritan Hospital- IL
Downers Grove, Illinois, United States, 60515
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
Heartland Education and Research Foundation
Joliet, Illinois, United States, 60435
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Heart Care Research Foundation
Mokena, Illinois, United States, 60448
Edward Heart Hospital
Naperville, Illinois, United States, 60540
United States, Indiana
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States, 46541
St. Vincent Heart Center of Indiana, LLC
Indianapolis, Indiana, United States, 46290
Northwest Indiana Cardiovascular Physicians, P.C.
Valparaiso, Indiana, United States, 46383
United States, Iowa
McFarland Clinic PC
Ames, Iowa, United States, 50010
St. Luke's Hospital - Cedar Rapids
Cedar Rapids, Iowa, United States, 52403
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
United States, Kentucky
Kings Daughters Medical Center
Ashland, Kentucky, United States, 41101
United States, Louisiana
Tulane University Medical School
New Orleans, Louisiana, United States, 70112
United States, Maine
Northeast Cardiology Associates
Bangor, Maine, United States, 04401
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Sinai Hospital at Baltimore
Baltimore, Maryland, United States, 21215
Shah Associates, LLC
Prince Frederick, Maryland, United States, 20678
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21804
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
Henry Ford Hospital Heart & Vascular Institute
Detroit, Michigan, United States, 48202
Harper University Hospital
Detroit, Michigan, United States, 48201-2018
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
St. Joseph Mercy-PTCMI
Pontiac, Michigan, United States, 48341
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073-6769
Covenant Medical Center
Saginaw, Michigan, United States, 48602
Great Lakes Heart & Vascular Institute, PC
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Beaumont Hospital Troy
Troy, Michigan, United States, 48085
United States, Minnesota
Mayo Clinic - Saint Marys Hospital
Rochester, Minnesota, United States, 55905
Central Minnesota Heart Center at St. Cloud Hospital
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Cardiology Associates Research LLC
Tupelo, Mississippi, United States, 38801
United States, Missouri
St. Luke's Hospital Mid America Heart Institute
Kansas City, Missouri, United States, 64111
Kansas City Heart Foundation
Kansas City, Missouri, United States, 64114
North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
St. John's Medical Institute
Springfield, Missouri, United States, 65807
St. Louis University Hospital
St. Louis, Missouri, United States, 63110
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
Washington University Hospital
St. Louis, Missouri, United States, 63110-1093
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
Alegent Health / Bergan Mercy Hospital
Omaha, Nebraska, United States, 68124
Creighton University
Omaha, Nebraska, United States, 68131
United States, New Hampshire
Catholic Medical Center
Manchester, New Hampshire, United States, 03102
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Cardiovascular Associates of the Delaware Valley, PA
Haddon Heights, New Jersey, United States, 08035
Hamilton Cardiology Associates
Hamilton, New Jersey, United States, 08690
Valley Hospital
Hawthorne, New Jersey, United States, 07506
UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
St. Michaels Hospital
Newark, New Jersey, United States, 07102
United States, New Mexico
Presbyterian Heart Group
Albuquerque, New Mexico, United States, 87106
United States, New York
SJH Cardiology Associates
Liverpool, New York, United States, 13088
Winthrop University Hospital
Mineola, New York, United States, 11501
Hudson Valley Heart Center
Poughkeepsie, New York, United States, 12601
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-8167
St. Elizabeth's Medical Center- NY
Utica, New York, United States, 13501
Westchester Medical Center
Valhalla, New York, United States, 10595
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28802
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Carolina Heart Specialists
Gastonia, North Carolina, United States, 28054
Carolina Cardiology Associates
High Point, North Carolina, United States, 27262
Wake Heart Association
Raleigh, North Carolina, United States, 27610
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157-1045
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
MeritCare Medical Center
Fargo, North Dakota, United States, 58122
Altru Health System
Grand Forks, North Dakota, United States, 58206
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0542
Riverside Methodist
Columbus, Ohio, United States, 43214
Elyria Memorial Hospital
Elyria, Ohio, United States, 44035
Frederick C Smith Clinic dba Smith Clinic
Marion, Ohio, United States, 43302
Northwest Ohio Cardiology
Toledo, Ohio, United States, 43615
United States, Oklahoma
Midwest Regional Medical Center
Midwest City, Oklahoma, United States, 73110
Oklahoma Foundation for CV Research
Oklahoma City, Oklahoma, United States, 73120
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
St. Vincent Hospital/ Providence Heart Hospital
Portland, Oregon, United States, 97225
Oregon Health & Sciences University Hospital
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Chambersburg Hospital
Chambersburg, Pennsylvania, United States, 17201
Geisinger Clinic
Danville, Pennsylvania, United States, 17822
Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
Pinnacle Health Hospital
Harrisburg, Pennsylvania, United States, 17110
Conemaugh Memorial Medical Center
Johnstown, Pennsylvania, United States, 15905
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States, 18840
Berks Cardiologists
Wyomissing, Pennsylvania, United States, 19610
York Hospital (PA)
York, Pennsylvania, United States, 17403
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Miriam Hospital
Providence, Rhode Island, United States, 02904
United States, South Carolina
AnMed Health
Anderson, South Carolina, United States, 29621
United States, South Dakota
Black Hills Research- Rapid City Regional
Rapid City, South Dakota, United States, 57701
North Central Heart Institute
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
Chattanooga Heart Institute
Chattanooga, Tennessee, United States, 37404
Chattanooga Heart - East Third Street
Chattanooga, Tennessee, United States, 37404
Centennial Heart Medical Center
Nashville, Tennessee, United States, 37203
United States, Texas
Austin Heart
Austin, Texas, United States, 78705
Texas Cardiovascular
Austin, Texas, United States, 78758
Capital Cardiovascular Research Institute
Austin, Texas, United States, 78745
CRSTI Research
Dallas, Texas, United States, 75230
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Veteran's Affairs Medical Center- Dallas
Dallas, Texas, United States, 75216
Methodist DeBakey Heart & Vascular Center
Houston, Texas, United States, 77030
North Dallas Research Associates
McKinney, Texas, United States, 75069
North Dallas Research Associate
McKinney, Texas, United States, 75069
The Heart Hospital / Baylor Plano
Plano, Texas, United States, 75093
Scott and White Healthcare - Round Rock
Round Rock, Texas, United States, 78665
TexSan Heart Hospital
San Antonio, Texas, United States, 78229
Mother Frances Hospital
Tyler, Texas, United States, 75701
Providence Healthcare Network
Waco, Texas, United States, 76712
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157-7000
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Rockingham Memorial Hospital
Harrisonburg, Virginia, United States, 22801
Lynchburg General Hospital
Lynchburg, Virginia, United States, 24501
Sentara, Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Carilion Clinic
Roanoke, Virginia, United States, 24014
Cardiovascular Associates, Ltd.
Virginia Beach, Virginia, United States, 23454
Winchester Medical Center
Winchester, Virginia, United States, 22601
United States, Washington
Providence St. Peter Hospital
Olympia, Washington, United States, 98506
University of Washington
Seattle, Washington, United States, 98195-8422
Inland Cardiology Associates
Spokane, Washington, United States, 99204
Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
CaRE Foundation, Inc.
Wausau, Wisconsin, United States, 54401
Australia, New South Wales
St. Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Prince of Wales Eastern Heart
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Prahran, Victoria, Australia, 3004
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
The Mount Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Australia
Monash Heart
Clayton, Australia, 3168
St Vincents Hospital Melbourne
Fitzroy, Australia, 3065
Czech Republic
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
Krajska karlovarska nemocnice a.s.
Karlovy Vary, Czech Republic, 360 66
Centrum pro choroby srdce a cev
Kromeriz, Czech Republic, 767 01
Mestska nemocnice Ostrava
Ostrava, Czech Republic, 701 00
Krajska nemocnice T. Bati a.s.
Zlin, Czech Republic, 76275
France
Centre Hospitalier Saint Louis
La Rochelle, France, 17000
Hospital Saint Philibert
Lomme, France, 59462
Nouvelles Cliniques Nantaises
Nantes, France, 44277
Clinique les Franciscaines
Nimes, France, 30000
Hopital Bichat
Paris, France, 75018
Groupe Hospitalier Sud
Pessac, France, 33604
CH Chatiliez Tourcoing
Tourcoing, France, 59208
Germany
Helios Klinikum Emil von Behring
Berlin, BE, Germany, 1
Universitaetsklinikum Schleswig-Holstein - PS
Luebeck, SH, Germany, 23538
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
Vivantes-Klinikum Neukoelln
Berlin, Germany, 13437
Vivantes-Klinikum Neukoelin
Berlin, Germany, 12351
Vivantes-Humboldt Klinikum
Berlin, Germany, 13509
Elbe-Kliniken Stade-Buxtehude GmbH
Buxtehude, Germany, 21614
Universitaetsklinikum Dresden
Dresden, Germany, 01307
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Herzzentrum Leipzig GmbH
Leipzig, Germany, 4289
Elbe-Kliniken Stade-Buxtehude GmbH
Stade, Germany, 21682
Hungary
Gottsegen Gyorgy Orszagos Kardiologiai Intezet
Budapest, Hungary, 1096
Josa Andras Oktato Korhaz Nonprofit Kft
Nyiregyhaza, Hungary, 4400
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont
Szeged, Hungary, 6720
Zala Megyei Korhaz
Zalaegerszeg, Hungary, 8900
New Zealand
Mercy Angiography
Epsom, Auckland, New Zealand, 00000
North Shore Hospital
Auckland, New Zealand, 0622
Middlemore Hospital
Auckland, New Zealand
Ascot Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand, 8001
Waikato Hospital
Hamilton, New Zealand, 3240
Nelson Hospital
Nelson, New Zealand
Wakefield Hospital
Wellington, New Zealand, 6039
Wellington Hospital
Wellington, New Zealand, 6021
Poland
Uniwersyteck Szpital Klin. w Bialymstoku
Bialystok, Poland, 15-276
Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ
Bydgoszcz, Poland, 85-826
NZOZ Centrum Medyczne Beluga-Med
Krakow, Poland, 30-069
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-501
SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie
Szczecin, Poland, 70-111
Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S
Ustron, Poland, 43-450
Instytut Kardiologii im. Kardynala St. Wyszynskiego
Warszawa, Poland, 04-637
Romania
Spitalul Clinic de Urgenta Bucuresti
Bucuresti, Romania, 14461
Spitalul Clinic Universitar de Urgenta Bucuresti
Bucuresti, Romania, 50098
Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu
Bucuresti, Romania, 22328
Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei
Bucuresti, Romania, 10242
Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.
Bucuresti, Romania, 22328
Institutul Inimii Niculae Stancioiu Cluj-Napoca
Cluj-Napoca, Romania, 400001
Institutul de Boli Cardiovasculare si Transplant Targu Mures
Targu Mures, Romania, 540136
United Kingdom
Wycombe General Hospital
High Wycombe, Bucks, United Kingdom, HP11 2TT
Papworth Hospital
Cambridge, Cambs, United Kingdom, CB3 8RE
Torbay hospital
Torquay, Devon, United Kingdom, TQ2 7AA
Royal Bournemouth General Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Basildon University Hospital
Basildon, Essex, United Kingdom, SS16 5NL
Barnet Hospital
Barnet, Herts, United Kingdom, EN5 3DJ
James Cook Hospital
Middlesborough, N York, United Kingdom, TS4 3BW
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Weston General Hospital
Weston Super Mare, Somerset, United Kingdom, BS23 4TQ
Golden Jubilee National Hospital
Glasgow, Strath, United Kingdom, F81 4HX
St Peter's Hospital
Chertsey, United Kingdom, KT16 OPZ
University Hospital of Coventry and Warwickshire
Coventry, United Kingdom, CV2 2DX
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
University Hospital of Leicester Glenfield Hospital
Leicester, United Kingdom, LE3 9QP
The London Chest Hospital
London, United Kingdom, E2 9JX
Freeman Hospital
Newcastle, United Kingdom, NE7 7AW
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Harvard Clinical Research Institute
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis Corporation
Eli Lilly and Company
Daiichi Sankyo Inc.
Medtronic
Investigators
Principal Investigator: Laura Mauri, MD, MSc Brigham and Women's Hospital
Principal Investigator: Dean Kereiakes, MD, FACC Christ Hospital Heart and Vascular Center
  More Information

No publications provided by Harvard Clinical Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harvard Clinical Research Institute
ClinicalTrials.gov Identifier: NCT00977938     History of Changes
Other Study ID Numbers: HCRIG080186
Study First Received: September 14, 2009
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Harvard Clinical Research Institute:
Acute Coronary Syndrome
Adverse event
Antiplatelet therapy
Sirolimus
Everolimus
Paclitaxel
Zotarolimus
Bare Metal Stent
Drug Eluting Stent
Clinical Events Committee
Dual antiplatelet therapy
Harvard Clinical Research Institute
Major Adverse Cardiac and Cerebral Event
Major Bleeding
Myocardial infarction
Myocardial ischemia
Percutaneous coronary intervention
Stent placement
Stent Thrombosis
Thienopyridine
Clopidogrel
Prasugrel

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Prasugrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on August 28, 2014