AzTrials
AzTrials

Coronary Artery DiseasePhase 4NCT00977938

The Dual Antiplatelet Therapy Study (DAPT Study)

A Phase 4 study testing Clopidogrel & Aspirin, Prasugrel & Aspirin in people with Coronary Artery Disease, run by Baim Institute for Clinical Research at 256 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Clopidogrel & Aspirin, Prasugrel & Aspirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25,682 participants
Where
256 sitesin 10 countries
Study dates
Oct 2009to Jun 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is > 18 years of age.
  • Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
  • Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
  • 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.
  • 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.

Who cannot join

  • Index procedure stent placement with stent diameter <2.25 mm or >4.0 mm.
  • Pregnant women.
  • Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment.
  • Current medical condition with a life expectancy of less than 3 years.
  • 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.
  • Subjects on warfarin or similar anticoagulant therapy.
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  • Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted.
  • Subjects unable to give informed consent.
  • Subject treated with both DES and BMS during the index procedure.
  • Pregnant women.
  • Subject switched thienopyridine type or dose within 6 months prior to randomization.
  • Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
  • Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
  • Current medical condition with a life expectancy of less than 3 years.
  • Subjects on warfarin or similar anticoagulant therapy.

Trial locations and contacts

256 sites in 10 countries.

256 sites in 10 countries

United States178 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106

  • McFarland Clinic PC

    Ames, Iowa, 50010

  • AnMed Health

    Anderson, South Carolina, 29621

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28802

  • Kings Daughters Medical Center

    Ashland, Kentucky, 41101

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Hospital Research Institute

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Palm Beach Heart Research Institute

    Atlantis, Florida, 33462

  • Medical Center of Aurora

    Aurora, Colorado, 80012

  • Austin Heart

    Austin, Texas, 78705

  • Capital Cardiovascular Research Institute

    Austin, Texas, 78745

  • Texas Cardiovascular

    Austin, Texas, 78758

  • Sinai Hospital at Baltimore

    Baltimore, Maryland, 21215

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Northeast Cardiology Associates

    Bangor, Maine, 04401

  • Advocate Good Shephard Hospital

    Barrington, Illinois, 60010

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bay Area Cardiology Associates/ Brandon Regional Hospital

    Brandon, Florida, 33511

  • Connecticut Clinical Research, LLC

    Bridgeport, Connecticut, 06606

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Lahey Clinic Medical Center

    Burlington, Massachusetts, 01805

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • St. Luke's Hospital - Cedar Rapids

    Cedar Rapids, Iowa, 52403

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Chattanooga Heart - East Third Street

    Chattanooga, Tennessee, 37404

  • Chattanooga Heart Institute

    Chattanooga, Tennessee, 37404

  • Jesse Brown VA Medical Center

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267-0542

  • Riverside Methodist

    Columbus, Ohio, 43214

  • Veteran's Affairs Medical Center- Dallas

    Dallas, Texas, 75216

  • CRSTI Research

    Dallas, Texas, 75230

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Clinic

    Danville, Pennsylvania, 17822

  • Harper University Hospital

    Detroit, Michigan, 48201-2018

  • Henry Ford Hospital Heart & Vascular Institute

    Detroit, Michigan, 48202

  • Good Samaritan Hospital- IL

    Downers Grove, Illinois, 60515

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Midwest Cardiovascular Research and Education Foundation

    Elkhart, Indiana, 46541

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Elyria Memorial Hospital

    Elyria, Ohio, 44035

  • Thomas Hospital

    Fairhope, Alabama, 36532

  • MeritCare Medical Center

    Fargo, North Dakota, 58122

  • California Cardiovascular Consultants/ Washington Hospital

    Fremont, California, 94538

  • Carolina Heart Specialists

    Gastonia, North Carolina, 28054

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Altru Health System

    Grand Forks, North Dakota, 58206

  • Cardiovascular Associates of the Delaware Valley, PA

    Haddon Heights, New Jersey, 08035

  • Hamilton Cardiology Associates

    Hamilton, New Jersey, 08690

  • Pinnacle Health Hospital

    Harrisburg, Pennsylvania, 17110

  • Rockingham Memorial Hospital

    Harrisonburg, Virginia, 22801

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Valley Hospital

    Hawthorne, New Jersey, 07506

  • Carolina Cardiology Associates

    High Point, North Carolina, 27262

  • Methodist DeBakey Heart & Vascular Center

    Houston, Texas, 77030

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • St. Vincent Heart Center of Indiana, LLC

    Indianapolis, Indiana, 46290

  • Jacksonville Heart Center

    Jacksonville, Florida, 32207

  • Conemaugh Memorial Medical Center

    Johnstown, Pennsylvania, 15905

  • Heartland Education and Research Foundation

    Joliet, Illinois, 60435

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • St. Luke's Hospital Mid America Heart Institute

    Kansas City, Missouri, 64111

  • Kansas City Heart Foundation

    Kansas City, Missouri, 64114

  • The Foundation for Cardiovascular Medicine

    La Jolla, California, 92037

  • Watson Clinic Center for Research

    Lakeland, Florida, 33805

  • Diagnostic Cardiology Associates

    Lauderdale Lakes, Florida, 33313

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • University of Arkansas (Central VA) for Medical Science

    Little Rock, Arkansas, 72205

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • SJH Cardiology Associates

    Liverpool, New York, 13088

  • Lynchburg General Hospital

    Lynchburg, Virginia, 24501

  • Medical Center Central Georgia

    Macon, Georgia, 31201

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Frederick C Smith Clinic dba Smith Clinic

    Marion, Ohio, 43302

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • North Dallas Research Associates

    McKinney, Texas, 75069

  • North Dallas Research Associate

    McKinney, Texas, 75069

  • Melbourne Internal Medicine Assoc

    Melbourne, Florida, 32901

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Midwest Regional Medical Center

    Midwest City, Oklahoma, 73110

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Heart Care Research Foundation

    Mokena, Illinois, 60448

  • Intermountain Medical Center

    Murray, Utah, 84157-7000

  • Edward Heart Hospital

    Naperville, Illinois, 60540

  • Centennial Heart Medical Center

    Nashville, Tennessee, 37203

  • UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Tulane University Medical School

    New Orleans, Louisiana, 70112

  • St. Michaels Hospital

    Newark, New Jersey, 07102

  • Sentara, Norfolk General Hospital

    Norfolk, Virginia, 23507

  • North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Munroe Regional Medical Center

    Ocala, Florida, 34471

  • Ocala Regional Medical Center

    Ocala, Florida, 34480

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Oklahoma Foundation for CV Research

    Oklahoma City, Oklahoma, 73120

  • Providence St. Peter Hospital

    Olympia, Washington, 98506

  • Alegent Health / Bergan Mercy Hospital

    Omaha, Nebraska, 68124

  • Creighton University

    Omaha, Nebraska, 68131

  • Florida Hospital

    Orlando, Florida, 32803

  • Baptist Hospital

    Pensacola, Florida, 32501

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Heart & Vascular Center of Arizona

    Phoenix, Arizona, 85006

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • The Heart Hospital / Baylor Plano

    Plano, Texas, 75093

  • St. Joseph Mercy-PTCMI

    Pontiac, Michigan, 48341

  • Maine Medical Center

    Portland, Maine, 04102

  • St. Vincent Hospital/ Providence Heart Hospital

    Portland, Oregon, 97225

  • Oregon Health & Sciences University Hospital

    Portland, Oregon, 97239-3098

  • Hudson Valley Heart Center

    Poughkeepsie, New York, 12601

  • Shah Associates, LLC

    Prince Frederick, Maryland, 20678

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02904

  • Wake Heart Association

    Raleigh, North Carolina, 27610

  • Black Hills Research- Rapid City Regional

    Rapid City, South Dakota, 57701

  • Carilion Clinic

    Roanoke, Virginia, 24014

  • Mayo Clinic - Saint Marys Hospital

    Rochester, Minnesota, 55905

  • Redmond Regional Hospital

    Rome, Georgia, 30165

  • Scott and White Healthcare - Round Rock

    Round Rock, Texas, 78665

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-6769

  • Mercy General Hospital

    Sacramento, California, 95819

  • Covenant Medical Center

    Saginaw, Michigan, 48602

  • Central Minnesota Heart Center at St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Great Lakes Heart & Vascular Institute, PC

    Saint Joseph, Michigan, 49085

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21804

  • TexSan Heart Hospital

    San Antonio, Texas, 78229

  • UC San Diego Medical Center

    San Diego, California, 92103-8784

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Donald Guthrie Foundation for Education and Research

    Sayre, Pennsylvania, 18840

  • Scottsdale Health Care

    Scottsdale, Arizona, 85258

  • University of Washington

    Seattle, Washington, 98195-8422

  • North Central Heart Institute

    Sioux Falls, South Dakota, 57105

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117

  • Inland Cardiology Associates

    Spokane, Washington, 99204

  • Sacred Heart Medical Center

    Spokane, Washington, 99204

  • St. John's Medical Institute

    Springfield, Missouri, 65807

  • Washington University Hospital

    St Louis, Missouri, 63110-1093

  • St. Louis University Hospital

    St Louis, Missouri, 63110

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • St. Vincent's Medical Center

    Stamford, Connecticut, 06905

  • St. Joseph's Medical Center- CA

    Stockton, California, 95204-6088

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-8167

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Pepin Heart Hospital

    Tampa, Florida, 33613

  • Northwest Ohio Cardiology

    Toledo, Ohio, 43615

  • Torrance Memorial Medical Center / Vasek Polak Research Program

    Torrance, California, 90505

  • Harbor - UCLA Medical Center

    Torrance, California, 90509

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Beaumont Hospital Troy

    Troy, Michigan, 48085

  • Cardiology Associates Research LLC

    Tupelo, Mississippi, 38801

  • Mother Frances Hospital

    Tyler, Texas, 75701

  • St. Elizabeth's Medical Center- NY

    Utica, New York, 13501

  • Westchester Medical Center

    Valhalla, New York, 10595

  • Northwest Indiana Cardiovascular Physicians, P.C.

    Valparaiso, Indiana, 46383

  • Cardiovascular Associates, Ltd.

    Virginia Beach, Virginia, 23454

  • Providence Healthcare Network

    Waco, Texas, 76712

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • CaRE Foundation, Inc.

    Wausau, Wisconsin, 54401

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • Winchester Medical Center

    Winchester, Virginia, 22601

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina, 27157-1045

  • Winter Haven Hospital

    Winter Haven, Florida, 33881

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Berks Cardiologists

    Wyomissing, Pennsylvania, 19610

  • York Hospital (PA)

    York, Pennsylvania, 17403

Other trials in United States

United Kingdom18 sites

  • Barnet Hospital

    Barnet, Herts, EN5 3DJ

  • Basildon University Hospital

    Basildon, Essex, SS16 5NL

  • Royal Bournemouth General Hospital

    Bournemouth, Dorset, BH7 7DW

  • Papworth Hospital

    Cambridge, Cambs, CB3 8RE

  • St Peter's Hospital

    Chertsey, KT16 OPZ

  • University Hospital of Coventry and Warwickshire

    Coventry, CV2 2DX

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • Golden Jubilee National Hospital

    Glasgow, Strath, F81 4HX

  • Wycombe General Hospital

    High Wycombe, Bucks, HP11 2TT

  • University Hospital of Leicester Glenfield Hospital

    Leicester, LE3 9QP

  • The London Chest Hospital

    London, E2 9JX

  • James Cook Hospital

    Middlesbrough, N York, TS4 3BW

  • Freeman Hospital

    Newcastle, NE7 7AW

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Torbay hospital

    Torquay, Devon, TQ2 7AA

  • Weston General Hospital

    Weston-super-Mare, Somerset, BS23 4TQ

Other trials in United Kingdom

Germany11 sites

  • Helios Klinikum Emil von Behring

    Berlin, State of Berlin, 1

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249

  • Vivantes-Klinikum Neukoelin

    Berlin, 12351

  • Vivantes-Klinikum Neukoelln

    Berlin, 13437

  • Vivantes-Humboldt Klinikum

    Berlin, 13509

  • Elbe-Kliniken Stade-Buxtehude GmbH

    Buxtehude, 21614

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Herzzentrum Leipzig GmbH

    Leipzig, 4289

  • Universitaetsklinikum Schleswig-Holstein - PS

    Lübeck, Schleswig-Holstein, 23538

  • Elbe-Kliniken Stade-Buxtehude GmbH

    Stade, 21682

Other trials in Germany

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Heart

    Clayton, 3168

  • St. Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • The Mount Hospital

    Nedlands, Western Australia, 6009

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • The Alfred Hospital

    Prahran, Victoria, 3004

  • Prince of Wales Eastern Heart

    Randwick, New South Wales, 2031

Other trials in Australia

New Zealand9 sites

  • North Shore Hospital

    Auckland, 0622

  • Ascot Hospital

    Auckland

  • Middlemore Hospital

    Auckland

  • Christchurch Hospital

    Christchurch, 8001

  • Mercy Angiography

    Epsom, Auckland, 00000

  • Waikato Hospital

    Hamilton, 3240

  • Nelson Hospital

    Nelson

  • Wellington Hospital

    Wellington, 6021

  • Wakefield Hospital

    Wellington, 6039

Other trials in New Zealand

France7 sites

  • Centre Hospitalier Saint Louis

    La Rochelle, 17000

  • Hospital Saint Philibert

    Lomme, 59462

  • Nouvelles Cliniques Nantaises

    Nantes, 44277

  • Clinique les Franciscaines

    Nîmes, 30000

  • Hopital Bichat

    Paris, 75018

  • Groupe Hospitalier Sud

    Pessac, 33604

  • CH Chatiliez Tourcoing

    Tourcoing, 59208

Other trials in France

Poland7 sites

  • Uniwersyteck Szpital Klin. w Bialymstoku

    Bialystok, 15-276

  • Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ

    Bydgoszcz, 85-826

  • NZOZ Centrum Medyczne Beluga-Med

    Krakow, 30-069

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

    Szczecin, 70-111

  • Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S

    Ustroń, 43-450

  • Instytut Kardiologii im. Kardynala St. Wyszynskiego

    Warsaw, 04-637

Other trials in Poland

Romania7 sites

  • Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei

    Bucharest, 10242

  • Spitalul Clinic de Urgenta Bucuresti

    Bucharest, 14461

  • Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu

    Bucharest, 22328

  • Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.

    Bucharest, 22328

  • Spitalul Clinic Universitar de Urgenta Bucuresti

    Bucharest, 50098

  • Institutul Inimii Niculae Stancioiu Cluj-Napoca

    Cluj-Napoca, 400001

  • Institutul de Boli Cardiovasculare si Transplant Targu Mures

    Târgu Mureş, 540136

Other trials in Romania

Czechia5 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Krajska karlovarska nemocnice a.s.

    Karlovy Vary, 360 66

  • Centrum pro choroby srdce a cev

    Kroměříž, 767 01

  • Mestska nemocnice Ostrava

    Ostrava, 701 00

  • Krajska nemocnice T. Bati a.s.

    Zlín, 76275

Other trials in Czechia

Hungary5 sites

  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet

    Budapest, 1096

  • Josa Andras Oktato Korhaz Nonprofit Kft

    Nyíregyháza, 4400

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont

    Szeged, 6720

  • Zala Megyei Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

About this study

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

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.

Read the 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.

Being tested
Placebo & Aspirin, Clopidogrel & Aspirin, Prasugrel & Aspirin
Keywords
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
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo & AspirinDrug

  • Clopidogrel & Aspirin, Prasugrel & AspirinDrug

Study groups in NCT00977938
Study groupRoleWhat they receive
12m DAPT Study ArmPlacebo comparatorThis 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.
Receives: Drug: Placebo & Aspirin
30m DAPT Study ArmActive comparatorThis 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.
Receives: Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

    The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.

    Measured: 18 months (12-30 months post-index procedure)

  2. Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT

    The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.

    Measured: 18 months (12-30 months post-index procedure)

  3. GUSTO Severe or Moderate Bleeding - Randomized DES ITT

    The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.

    Measured: 18 months (12-30 months post-index procedure)

Secondary outcomes (11)

  1. MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS

    Secondary powered endpoint

    Measured: 33 months (0-33 months post-index procedure)

  2. Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS

    Secondary powered endpoint

    Measured: 33 months (0-33 months post-index procedure)

  3. MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

    Measured: 21 months (12-33 months post-index procedure)

  4. Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT

    ST was assessed according to the Academic Research Consortium (ARC) definitions.

    Measured: 21 months (12-33 months post-index procedure)

  5. GUSTO Severe or Moderate Bleeding - Randomized DES ITT

    Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.

    Measured: 21 months (12-33 months post-index procedure)

  6. MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT

    Measured: 18 months (12-30 months post-index procedure)

  7. Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT

    ST was assessed according to the Academic Research Consortium (ARC) definitions.

    Measured: 18 months (12-30 months post-index procedure)

  8. GUSTO Severe or Moderate Bleeding - Randomized BMS ITT

    Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.

    Measured: 18 months (12-30 months post-index procedure)

  9. MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT

    Measured: 21 months (12-33 months post-index procedure)

  10. Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT

    ST was assessed according to the Academic Research Consortium (ARC) definitions.

    Measured: 21 months (12-33 months post-index procedure)

  11. GUSTO Severe or Moderate Bleeding - Randomized BMS ITT

    Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.

    Measured: 21 months (12-33 months post-index procedure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
25,682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00977938
Sponsor's protocol ID
HCRIG080186
Status last verified
May 2017
First submitted
14 Sep 2009
Last updated
9 Jun 2017
Data monitoring committee
Yes

Publications

  • Faridi KF, Strom JB, Kundi H, Butala NM, Curtis JP, Gao Q, Song Y, Zheng L, Tamez H, Shen C, Secemsky EA, Yeh RW. Association Between Claims-Defined Frailty and Outcomes Following 30 Versus 12 Months of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: Findings From the EXTEND-DAPT Study. J Am Heart Assoc. 2023 Jul 18;12(14):e029588. doi: 10.1161/JAHA.123.029588. Epub 2023 Jul 14.

    PubMed 37449567

  • Berg DD, Yeh RW, Mauri L, Morrow DA, Kereiakes DJ, Cutlip DE, Gao Q, Jarolim P, Michelson AD, Frelinger AL 3rd, Cange AL, Sabatine MS, O'Donoghue ML. Biomarkers of platelet activation and cardiovascular risk in the DAPT trial. J Thromb Thrombolysis. 2021 Apr;51(3):675-681. doi: 10.1007/s11239-020-02221-5.

    PubMed 32683645

  • Stefanescu Schmidt AC, Steg PG, Yeh RW, Kereiakes DJ, Tanguay JF, Hsieh WH, Massaro JM, Mauri L, Cutlip DE; DAPT Investigators. Interruption of Dual Antiplatelet Therapy Within Six Months After Coronary Stents (from the Dual Antiplatelet Therapy Study). Am J Cardiol. 2019 Dec 15;124(12):1813-1820. doi: 10.1016/j.amjcard.2019.09.006. Epub 2019 Sep 26.

    PubMed 31653353

  • Berry NC, Kereiakes DJ, Yeh RW, Steg PG, Cutlip DE, Jacobs AK, Abbott JD, Hsieh WH, Massaro JM, Mauri L; DAPT Study Investigators. Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e005308. doi: 10.1161/CIRCINTERVENTIONS.117.005308.

    PubMed 30354781

  • Yeh RW, Kereiakes DJ, Steg PG, Cutlip DE, Croce KJ, Massaro JM, Mauri L; DAPT Study Investigators. Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Oct 31;70(18):2213-2223. doi: 10.1016/j.jacc.2017.09.011.

    PubMed 29073947

  • Secemsky EA, Yeh RW, Kereiakes DJ, Cutlip DE, Cohen DJ, Steg PG, Cannon CP, Apruzzese PK, D'Agostino RB Sr, Massaro JM, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary Stenting: A Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study. JAMA Cardiol. 2017 May 1;2(5):478-487. doi: 10.1001/jamacardio.2017.0063.

    PubMed 28297015

  • Stefanescu Schmidt AC, Kereiakes DJ, Cutlip DE, Yeh RW, D'Agostino RB Sr, Massaro JM, Hsieh WH, Mauri L; DAPT Investigators. Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy). Circulation. 2017 May 2;135(18):1720-1732. doi: 10.1161/CIRCULATIONAHA.116.024835. Epub 2017 Feb 22.

    PubMed 28228427

  • Resor CD, Nathan A, Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Gabriel Steg P, Hsieh WH, Mauri L; Dual Antiplatelet Therapy Study Investigators. Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. Circulation. 2016 Oct 4;134(14):989-998. doi: 10.1161/CIRCULATIONAHA.116.024531. Epub 2016 Aug 30.

    PubMed 27576774

  • Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Steg PG, Wiviott SD, Mauri L; DAPT Study Investigators. DAPT Score Utility for Risk Prediction in Patients With or Without Previous Myocardial Infarction. J Am Coll Cardiol. 2016 May 31;67(21):2492-502. doi: 10.1016/j.jacc.2016.03.485. Epub 2016 Apr 1.

    PubMed 27046159

  • Yeh RW, Secemsky EA, Kereiakes DJ, Normand SL, Gershlick AH, Cohen DJ, Spertus JA, Steg PG, Cutlip DE, Rinaldi MJ, Camenzind E, Wijns W, Apruzzese PK, Song Y, Massaro JM, Mauri L; DAPT Study Investigators. Development and Validation of a Prediction Rule for Benefit and Harm of Dual Antiplatelet Therapy Beyond 1 Year After Percutaneous Coronary Intervention. JAMA. 2016 Apr 26;315(16):1735-49. doi: 10.1001/jama.2016.3775.

    PubMed 27022822

  • Meredith IT, Tanguay JF, Kereiakes DJ, Cutlip DE, Yeh RW, Garratt KN, Lee DP, Steg PG, Weaver WD, Holmes DR Jr, Brindis RG, Trebacz J, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Diabetes Mellitus and Prevention of Late Myocardial Infarction After Coronary Stenting in the Randomized Dual Antiplatelet Therapy Study. Circulation. 2016 May 3;133(18):1772-82. doi: 10.1161/CIRCULATIONAHA.115.016783. Epub 2016 Mar 18.

    PubMed 26994121

  • Hermiller JB, Krucoff MW, Kereiakes DJ, Windecker S, Steg PG, Yeh RW, Cohen DJ, Cutlip DE, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents. JACC Cardiovasc Interv. 2016 Jan 25;9(2):138-47. doi: 10.1016/j.jcin.2015.10.001.

    PubMed 26793956

  • Mauri L, Elmariah S, Yeh RW, Cutlip DE, Steg PG, Windecker S, Wiviott SD, Cohen DJ, Massaro JM, D'Agostino RB Sr, Braunwald E, Kereiakes DJ; DAPT Study Investigators. Causes of late mortality with dual antiplatelet therapy after coronary stents. Eur Heart J. 2016 Jan 21;37(4):378-85. doi: 10.1093/eurheartj/ehv614. Epub 2015 Nov 18.

    PubMed 26586780

  • Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; DAPT Study Investigators. Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy. JACC Cardiovasc Interv. 2015 Oct;8(12):1552-62. doi: 10.1016/j.jcin.2015.05.026.

    PubMed 26493248

  • Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction. J Am Coll Cardiol. 2015 May 26;65(20):2211-21. doi: 10.1016/j.jacc.2015.03.003. Epub 2015 Mar 15.

    PubMed 25787199

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel & Aspirin, Prasugrel & Aspirin in people with Coronary Artery Disease, run by Baim Institute for Clinical Research at 256 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 256 sites in United States, United Kingdom, Germany, Australia, New Zealand and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT (time frame: 18 months (12-30 months post-index procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00977938, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.

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The Dual Antiplatelet Therapy Study (DAPT Study) | AzTrials