The Dual Antiplatelet Therapy Study (DAPT Study)
Coronary Artery Disease

About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring 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
Eligibility Criteria
Inclusion Criteria (Enrollment):
- 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.
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):
- 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.
- 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.
Exclusion Criteria (Randomization at 12 months):
- 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.
Sites / Locations
- Thomas Hospital
- Mercy Gilbert Medical Center
- Heart & Vascular Center of Arizona
- Scottsdale Health Care
- NEA Baptist Clinic
- University of Arkansas (Central VA) for Medical Science
- Arkansas Heart Hospital
- California Cardiovascular Consultants/ Washington Hospital
- The Foundation for Cardiovascular Medicine
- Mercy General Hospital
- UC San Diego Medical Center
- California Pacific Medical Center
- St. Joseph's Medical Center- CA
- Torrance Memorial Medical Center / Vasek Polak Research Program
- Harbor - UCLA Medical Center
- Medical Center of Aurora
- Connecticut Clinical Research, LLC
- Bridgeport Hospital
- St. Vincent's Medical Center
- Washington Hospital Center
- Palm Beach Heart Research Institute
- Bay Area Cardiology Associates/ Brandon Regional Hospital
- Jacksonville Heart Center
- Watson Clinic Center for Research
- Diagnostic Cardiology Associates
- Melbourne Internal Medicine Assoc
- Baptist Hospital of Miami
- Munroe Regional Medical Center
- Ocala Regional Medical Center
- Florida Hospital
- Baptist Hospital
- Sacred Heart Hospital
- Tallahassee Memorial Hospital
- Pepin Heart Hospital
- Winter Haven Hospital
- Emory University Hospital Midtown
- Piedmont Hospital Research Institute
- Emory University Hospital
- Medical Center Central Georgia
- Redmond Regional Hospital
- Advocate Good Shephard Hospital
- Jesse Brown VA Medical Center
- Rush University Medical Center
- University of Illinois at Chicago
- Good Samaritan Hospital- IL
- Elmhurst Memorial Hospital
- Heartland Education and Research Foundation
- Loyola University Medical Center
- Heart Care Research Foundation
- Edward Heart Hospital
- Midwest Cardiovascular Research and Education Foundation
- St. Vincent Heart Center of Indiana, LLC
- Northwest Indiana Cardiovascular Physicians, P.C.
- McFarland Clinic PC
- St. Luke's Hospital - Cedar Rapids
- Iowa Heart Center
- Kings Daughters Medical Center
- Tulane University Medical School
- Northeast Cardiology Associates
- Maine Medical Center
- Sinai Hospital at Baltimore
- Union Memorial Hospital
- Shah Associates, LLC
- Peninsula Regional Medical Center
- Washington Adventist Hospital
- Brigham and Women's Hospital
- Boston Medical Center
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Center
- Lahey Clinic Medical Center
- Cape Cod Hospital
- UMass Memorial Medical Center
- Bay Regional Medical Center
- Harper University Hospital
- Henry Ford Hospital Heart & Vascular Institute
- Borgess Medical Center
- St. Joseph Mercy-PTCMI
- William Beaumont Hospital
- Covenant Medical Center
- Great Lakes Heart & Vascular Institute, PC
- Munson Medical Center
- Beaumont Hospital Troy
- Mayo Clinic - Saint Marys Hospital
- Central Minnesota Heart Center at St. Cloud Hospital
- Hattiesburg Clinic
- Cardiology Associates Research LLC
- St. Luke's Hospital Mid America Heart Institute
- Kansas City Heart Foundation
- North Kansas City Hospital
- Washington University Hospital
- St. Louis University Hospital
- St. John's Mercy Medical Center
- St. John's Medical Institute
- Nebraska Heart Institute
- Alegent Health / Bergan Mercy Hospital
- Creighton University
- Catholic Medical Center
- Cooper University Hospital
- Cardiovascular Associates of the Delaware Valley, PA
- Hamilton Cardiology Associates
- Valley Hospital
- UMDNJ - Robert Wood Johnson Medical School
- St. Michaels Hospital
- Presbyterian Heart Group
- SJH Cardiology Associates
- Winthrop University Hospital
- Hudson Valley Heart Center
- Stony Brook University Medical Center
- St. Elizabeth's Medical Center- NY
- Westchester Medical Center
- Asheville Cardiology Associates
- Carolinas Medical Center
- Carolina Heart Specialists
- Carolina Cardiology Associates
- Wake Heart Association
- Forsyth Medical Center
- Wake Forest Health Sciences
- MeritCare Medical Center
- Altru Health System
- The Lindner Clinical Trial Center
- Good Samaritan Hospital
- University of Cincinnati Medical Center
- Riverside Methodist
- Elyria Memorial Hospital
- Frederick C Smith Clinic dba Smith Clinic
- Northwest Ohio Cardiology
- Midwest Regional Medical Center
- University of Oklahoma Health Sciences Center
- Oklahoma Foundation for CV Research
- St. Vincent Hospital/ Providence Heart Hospital
- Oregon Health & Sciences University Hospital
- Abington Memorial Hospital
- Chambersburg Hospital
- Geisinger Clinic
- Doylestown Hospital
- Pinnacle Health Hospital
- Conemaugh Memorial Medical Center
- UPMC Presbyterian Hospital
- Donald Guthrie Foundation for Education and Research
- Berks Cardiologists
- York Hospital (PA)
- Rhode Island Hospital
- Miriam Hospital
- AnMed Health
- Black Hills Research- Rapid City Regional
- North Central Heart Institute
- Sanford USD Medical Center
- Chattanooga Heart - East Third Street
- Chattanooga Heart Institute
- Centennial Heart Medical Center
- Austin Heart
- Capital Cardiovascular Research Institute
- Texas Cardiovascular
- Veteran's Affairs Medical Center- Dallas
- CRSTI Research
- UT Southwestern Medical Center
- Methodist DeBakey Heart & Vascular Center
- North Dallas Research Associates
- North Dallas Research Associate
- The Heart Hospital / Baylor Plano
- Scott and White Healthcare - Round Rock
- TexSan Heart Hospital
- Mother Frances Hospital
- Providence Healthcare Network
- Intermountain Medical Center
- University of Virginia
- Rockingham Memorial Hospital
- Lynchburg General Hospital
- Sentara, Norfolk General Hospital
- Carilion Clinic
- Cardiovascular Associates, Ltd.
- Winchester Medical Center
- Providence St. Peter Hospital
- University of Washington
- Inland Cardiology Associates
- Sacred Heart Medical Center
- Aurora St. Luke's Medical Center
- CaRE Foundation, Inc.
- St. Vincents Hospital Sydney
- Prince of Wales Eastern Heart
- Royal Adelaide Hospital
- The Alfred Hospital
- Fremantle Hospital
- The Mount Hospital
- Royal Perth Hospital
- Monash Heart
- St Vincents Hospital Melbourne
- Fakultni nemocnice Hradec Kralove
- Krajska karlovarska nemocnice a.s.
- Centrum pro choroby srdce a cev
- Mestska nemocnice Ostrava
- Krajska nemocnice T. Bati a.s.
- Centre Hospitalier Saint Louis
- Hospital Saint Philibert
- Nouvelles Cliniques Nantaises
- Clinique les Franciscaines
- Hopital Bichat
- Groupe Hospitalier Sud
- CH Chatiliez Tourcoing
- Helios Klinikum Emil von Behring
- Universitaetsklinikum Schleswig-Holstein - PS
- Vivantes Klinikum im Friedrichshain
- Vivantes-Klinikum Neukoelin
- Vivantes-Klinikum Neukoelln
- Vivantes-Humboldt Klinikum
- Elbe-Kliniken Stade-Buxtehude GmbH
- Universitaetsklinikum Dresden
- Asklepios Klinik St. Georg
- Herzzentrum Leipzig GmbH
- Elbe-Kliniken Stade-Buxtehude GmbH
- Gottsegen Gyorgy Orszagos Kardiologiai Intezet
- Josa Andras Oktato Korhaz Nonprofit Kft
- Pecsi Tudomanyegyetem Klinikai Kozpont
- Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont
- Zala Megyei Korhaz
- Mercy Angiography
- North Shore Hospital
- Ascot Hospital
- Middlemore Hospital
- Christchurch Hospital
- Waikato Hospital
- Nelson Hospital
- Wellington Hospital
- Wakefield Hospital
- Uniwersyteck Szpital Klin. w Bialymstoku
- Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ
- NZOZ Centrum Medyczne Beluga-Med
- Szpital Uniwersytecki w Krakowie
- SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie
- Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S
- Instytut Kardiologii im. Kardynala St. Wyszynskiego
- Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei
- Spitalul Clinic de Urgenta Bucuresti
- Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu
- Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.
- Spitalul Clinic Universitar de Urgenta Bucuresti
- Institutul Inimii Niculae Stancioiu Cluj-Napoca
- Institutul de Boli Cardiovasculare si Transplant Targu Mures
- Wycombe General Hospital
- Papworth Hospital
- Torbay hospital
- Royal Bournemouth General Hospital
- Basildon University Hospital
- Barnet Hospital
- James Cook Hospital
- Ninewells Hospital
- Weston General Hospital
- Golden Jubilee National Hospital
- St Peter's Hospital
- University Hospital of Coventry and Warwickshire
- Ninewells Hospital
- Royal Infirmary of Edinburgh
- University Hospital of Leicester Glenfield Hospital
- The London Chest Hospital
- Freeman Hospital
- Derriford Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
12m DAPT Study Arm
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 18 months of placebo treatment in addition to aspirin.
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.