The Dual Antiplatelet Therapy Study (DAPT Study)
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
1 other identifier
interventional
25,682
10 countries
256
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Oct 2009
Longer than P75 for phase_4 coronary-artery-disease
256 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2009
CompletedFirst Posted
Study publicly available on registry
September 16, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
October 22, 2015
CompletedJune 9, 2017
May 1, 2017
4.7 years
September 14, 2009
September 18, 2015
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
18 months (12-30 months post-index procedure)
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.
18 months (12-30 months post-index procedure)
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.
18 months (12-30 months post-index procedure)
Secondary Outcomes (11)
MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS
33 months (0-33 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS
33 months (0-33 months post-index procedure)
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
21 months (12-33 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
21 months (12-33 months post-index procedure)
GUSTO Severe or Moderate Bleeding - Randomized DES ITT
21 months (12-33 months post-index procedure)
- +6 more secondary outcomes
Study Arms (2)
12m DAPT Study Arm
PLACEBO 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.
30m DAPT Study Arm
ACTIVE 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- \. 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baim Institute for Clinical Researchlead
- Abbottcollaborator
- Boston Scientific Corporationcollaborator
- Bristol-Myers Squibbcollaborator
- Sanofi-Synthelabocollaborator
- Cordis US Corp.collaborator
- Eli Lilly and Companycollaborator
- Daiichi Sankyocollaborator
- Medtroniccollaborator
Study Sites (256)
Thomas Hospital
Fairhope, Alabama, 36532, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Heart & Vascular Center of Arizona
Phoenix, Arizona, 85006, United States
Scottsdale Health Care
Scottsdale, Arizona, 85258, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
University of Arkansas (Central VA) for Medical Science
Little Rock, Arkansas, 72205, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
California Cardiovascular Consultants/ Washington Hospital
Fremont, California, 94538, United States
The Foundation for Cardiovascular Medicine
La Jolla, California, 92037, United States
Mercy General Hospital
Sacramento, California, 95819, United States
UC San Diego Medical Center
San Diego, California, 92103-8784, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
St. Joseph's Medical Center- CA
Stockton, California, 95204-6088, United States
Torrance Memorial Medical Center / Vasek Polak Research Program
Torrance, California, 90505, United States
Harbor - UCLA Medical Center
Torrance, California, 90509, United States
Medical Center of Aurora
Aurora, Colorado, 80012, United States
Connecticut Clinical Research, LLC
Bridgeport, Connecticut, 06606, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
St. Vincent's Medical Center
Stamford, Connecticut, 06905, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Palm Beach Heart Research Institute
Atlantis, Florida, 33462, United States
Bay Area Cardiology Associates/ Brandon Regional Hospital
Brandon, Florida, 33511, United States
Jacksonville Heart Center
Jacksonville, Florida, 32207, United States
Watson Clinic Center for Research
Lakeland, Florida, 33805, United States
Diagnostic Cardiology Associates
Lauderdale Lakes, Florida, 33313, United States
Melbourne Internal Medicine Assoc
Melbourne, Florida, 32901, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Munroe Regional Medical Center
Ocala, Florida, 34471, United States
Ocala Regional Medical Center
Ocala, Florida, 34480, United States
Florida Hospital
Orlando, Florida, 32803, United States
Baptist Hospital
Pensacola, Florida, 32501, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Pepin Heart Hospital
Tampa, Florida, 33613, United States
Winter Haven Hospital
Winter Haven, Florida, 33881, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Piedmont Hospital Research Institute
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Medical Center Central Georgia
Macon, Georgia, 31201, United States
Redmond Regional Hospital
Rome, Georgia, 30165, United States
Advocate Good Shephard Hospital
Barrington, Illinois, 60010, United States
Jesse Brown VA Medical Center
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Good Samaritan Hospital- IL
Downers Grove, Illinois, 60515, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Heartland Education and Research Foundation
Joliet, Illinois, 60435, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Heart Care Research Foundation
Mokena, Illinois, 60448, United States
Edward Heart Hospital
Naperville, Illinois, 60540, United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, 46541, United States
St. Vincent Heart Center of Indiana, LLC
Indianapolis, Indiana, 46290, United States
Northwest Indiana Cardiovascular Physicians, P.C.
Valparaiso, Indiana, 46383, United States
McFarland Clinic PC
Ames, Iowa, 50010, United States
St. Luke's Hospital - Cedar Rapids
Cedar Rapids, Iowa, 52403, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Kings Daughters Medical Center
Ashland, Kentucky, 41101, United States
Tulane University Medical School
New Orleans, Louisiana, 70112, United States
Northeast Cardiology Associates
Bangor, Maine, 04401, United States
Maine Medical Center
Portland, Maine, 04102, United States
Sinai Hospital at Baltimore
Baltimore, Maryland, 21215, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Shah Associates, LLC
Prince Frederick, Maryland, 20678, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21804, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Bay Regional Medical Center
Bay City, Michigan, 48708, United States
Harper University Hospital
Detroit, Michigan, 48201-2018, United States
Henry Ford Hospital Heart & Vascular Institute
Detroit, Michigan, 48202, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
St. Joseph Mercy-PTCMI
Pontiac, Michigan, 48341, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073-6769, United States
Covenant Medical Center
Saginaw, Michigan, 48602, United States
Great Lakes Heart & Vascular Institute, PC
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Beaumont Hospital Troy
Troy, Michigan, 48085, United States
Mayo Clinic - Saint Marys Hospital
Rochester, Minnesota, 55905, United States
Central Minnesota Heart Center at St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Cardiology Associates Research LLC
Tupelo, Mississippi, 38801, United States
St. Luke's Hospital Mid America Heart Institute
Kansas City, Missouri, 64111, United States
Kansas City Heart Foundation
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
St. John's Medical Institute
Springfield, Missouri, 65807, United States
Washington University Hospital
St Louis, Missouri, 63110-1093, United States
St. Louis University Hospital
St Louis, Missouri, 63110, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
Alegent Health / Bergan Mercy Hospital
Omaha, Nebraska, 68124, United States
Creighton University
Omaha, Nebraska, 68131, United States
Catholic Medical Center
Manchester, New Hampshire, 03102, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Cardiovascular Associates of the Delaware Valley, PA
Haddon Heights, New Jersey, 08035, United States
Hamilton Cardiology Associates
Hamilton, New Jersey, 08690, United States
Valley Hospital
Hawthorne, New Jersey, 07506, United States
UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
St. Michaels Hospital
Newark, New Jersey, 07102, United States
Presbyterian Heart Group
Albuquerque, New Mexico, 87106, United States
SJH Cardiology Associates
Liverpool, New York, 13088, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Hudson Valley Heart Center
Poughkeepsie, New York, 12601, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794-8167, United States
St. Elizabeth's Medical Center- NY
Utica, New York, 13501, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Asheville Cardiology Associates
Asheville, North Carolina, 28802, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Carolina Heart Specialists
Gastonia, North Carolina, 28054, United States
Carolina Cardiology Associates
High Point, North Carolina, 27262, United States
Wake Heart Association
Raleigh, North Carolina, 27610, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157-1045, United States
MeritCare Medical Center
Fargo, North Dakota, 58122, United States
Altru Health System
Grand Forks, North Dakota, 58206, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0542, United States
Riverside Methodist
Columbus, Ohio, 43214, United States
Elyria Memorial Hospital
Elyria, Ohio, 44035, United States
Frederick C Smith Clinic dba Smith Clinic
Marion, Ohio, 43302, United States
Northwest Ohio Cardiology
Toledo, Ohio, 43615, United States
Midwest Regional Medical Center
Midwest City, Oklahoma, 73110, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Foundation for CV Research
Oklahoma City, Oklahoma, 73120, United States
St. Vincent Hospital/ Providence Heart Hospital
Portland, Oregon, 97225, United States
Oregon Health & Sciences University Hospital
Portland, Oregon, 97239-3098, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201, United States
Geisinger Clinic
Danville, Pennsylvania, 17822, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
Pinnacle Health Hospital
Harrisburg, Pennsylvania, 17110, United States
Conemaugh Memorial Medical Center
Johnstown, Pennsylvania, 15905, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840, United States
Berks Cardiologists
Wyomissing, Pennsylvania, 19610, United States
York Hospital (PA)
York, Pennsylvania, 17403, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Miriam Hospital
Providence, Rhode Island, 02904, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Black Hills Research- Rapid City Regional
Rapid City, South Dakota, 57701, United States
North Central Heart Institute
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, 57117, United States
Chattanooga Heart - East Third Street
Chattanooga, Tennessee, 37404, United States
Chattanooga Heart Institute
Chattanooga, Tennessee, 37404, United States
Centennial Heart Medical Center
Nashville, Tennessee, 37203, United States
Austin Heart
Austin, Texas, 78705, United States
Capital Cardiovascular Research Institute
Austin, Texas, 78745, United States
Texas Cardiovascular
Austin, Texas, 78758, United States
Veteran's Affairs Medical Center- Dallas
Dallas, Texas, 75216, United States
CRSTI Research
Dallas, Texas, 75230, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Methodist DeBakey Heart & Vascular Center
Houston, Texas, 77030, United States
North Dallas Research Associates
McKinney, Texas, 75069, United States
North Dallas Research Associate
McKinney, Texas, 75069, United States
The Heart Hospital / Baylor Plano
Plano, Texas, 75093, United States
Scott and White Healthcare - Round Rock
Round Rock, Texas, 78665, United States
TexSan Heart Hospital
San Antonio, Texas, 78229, United States
Mother Frances Hospital
Tyler, Texas, 75701, United States
Providence Healthcare Network
Waco, Texas, 76712, United States
Intermountain Medical Center
Murray, Utah, 84157-7000, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Rockingham Memorial Hospital
Harrisonburg, Virginia, 22801, United States
Lynchburg General Hospital
Lynchburg, Virginia, 24501, United States
Sentara, Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
Cardiovascular Associates, Ltd.
Virginia Beach, Virginia, 23454, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
Providence St. Peter Hospital
Olympia, Washington, 98506, United States
University of Washington
Seattle, Washington, 98195-8422, United States
Inland Cardiology Associates
Spokane, Washington, 99204, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
CaRE Foundation, Inc.
Wausau, Wisconsin, 54401, United States
St. Vincents Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Prince of Wales Eastern Heart
Randwick, New South Wales, 2031, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Prahran, Victoria, 3004, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
The Mount Hospital
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Monash Heart
Clayton, 3168, Australia
St Vincents Hospital Melbourne
Fitzroy, 3065, Australia
Fakultni nemocnice Hradec Kralove
Hradec KrĂ¡lovĂ©, 500 05, Czechia
Krajska karlovarska nemocnice a.s.
Karlovy Vary, 360 66, Czechia
Centrum pro choroby srdce a cev
KroměřĂž, 767 01, Czechia
Mestska nemocnice Ostrava
Ostrava, 701 00, Czechia
Krajska nemocnice T. Bati a.s.
ZlĂn, 76275, Czechia
Centre Hospitalier Saint Louis
La Rochelle, 17000, France
Hospital Saint Philibert
Lomme, 59462, France
Nouvelles Cliniques Nantaises
Nantes, 44277, France
Clinique les Franciscaines
Nîmes, 30000, France
Hopital Bichat
Paris, 75018, France
Groupe Hospitalier Sud
Pessac, 33604, France
CH Chatiliez Tourcoing
Tourcoing, 59208, France
Universitaetsklinikum Schleswig-Holstein - PS
LĂ¼beck, Schleswig-Holstein, 23538, Germany
Helios Klinikum Emil von Behring
Berlin, State of Berlin, 1, Germany
Vivantes Klinikum im Friedrichshain
Berlin, 10249, Germany
Vivantes-Klinikum Neukoelin
Berlin, 12351, Germany
Vivantes-Klinikum Neukoelln
Berlin, 13437, Germany
Vivantes-Humboldt Klinikum
Berlin, 13509, Germany
Elbe-Kliniken Stade-Buxtehude GmbH
Buxtehude, 21614, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Asklepios Klinik St. Georg
Hamburg, 20099, Germany
Herzzentrum Leipzig GmbH
Leipzig, 4289, Germany
Elbe-Kliniken Stade-Buxtehude GmbH
Stade, 21682, Germany
Gottsegen Gyorgy Orszagos Kardiologiai Intezet
Budapest, 1096, Hungary
Josa Andras Oktato Korhaz Nonprofit Kft
NyĂregyhĂ¡za, 4400, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
PĂ©cs, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont
Szeged, 6720, Hungary
Zala Megyei Korhaz
Zalaegerszeg, 8900, Hungary
Mercy Angiography
Epsom, Auckland, 00000, New Zealand
North Shore Hospital
Auckland, 0622, New Zealand
Ascot Hospital
Auckland, New Zealand
Middlemore Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, 8001, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Nelson Hospital
Nelson, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Wakefield Hospital
Wellington, 6039, New Zealand
Uniwersyteck Szpital Klin. w Bialymstoku
Bialystok, 15-276, Poland
Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ
Bydgoszcz, 85-826, Poland
NZOZ Centrum Medyczne Beluga-Med
Krakow, 30-069, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie
Szczecin, 70-111, Poland
Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S
Ustroń, 43-450, Poland
Instytut Kardiologii im. Kardynala St. Wyszynskiego
Warsaw, 04-637, Poland
Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei
Bucharest, 10242, Romania
Spitalul Clinic de Urgenta Bucuresti
Bucharest, 14461, Romania
Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu
Bucharest, 22328, Romania
Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.
Bucharest, 22328, Romania
Spitalul Clinic Universitar de Urgenta Bucuresti
Bucharest, 50098, Romania
Institutul Inimii Niculae Stancioiu Cluj-Napoca
Cluj-Napoca, 400001, Romania
Institutul de Boli Cardiovasculare si Transplant Targu Mures
TĂ¢rgu MureÅŸ, 540136, Romania
Wycombe General Hospital
High Wycombe, Bucks, HP11 2TT, United Kingdom
Papworth Hospital
Cambridge, Cambs, CB3 8RE, United Kingdom
Torbay hospital
Torquay, Devon, TQ2 7AA, United Kingdom
Royal Bournemouth General Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Basildon University Hospital
Basildon, Essex, SS16 5NL, United Kingdom
Barnet Hospital
Barnet, Herts, EN5 3DJ, United Kingdom
James Cook Hospital
Middlesbrough, N York, TS4 3BW, United Kingdom
Ninewells Hospital
Dundee, Scotland, DD1 9SY, United Kingdom
Weston General Hospital
Weston-super-Mare, Somerset, BS23 4TQ, United Kingdom
Golden Jubilee National Hospital
Glasgow, Strath, F81 4HX, United Kingdom
St Peter's Hospital
Chertsey, KT16 OPZ, United Kingdom
University Hospital of Coventry and Warwickshire
Coventry, CV2 2DX, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
University Hospital of Leicester Glenfield Hospital
Leicester, LE3 9QP, United Kingdom
The London Chest Hospital
London, E2 9JX, United Kingdom
Freeman Hospital
Newcastle, NE7 7AW, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Related Publications (20)
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.
PMID: 37449567DERIVEDBerg 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.
PMID: 32683645DERIVEDStefanescu 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.
PMID: 31653353DERIVEDBerry 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.
PMID: 30354781DERIVEDYeh 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.
PMID: 29073947DERIVEDSecemsky 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.
PMID: 28297015DERIVEDStefanescu 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.
PMID: 28228427DERIVEDResor 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.
PMID: 27576774DERIVEDKereiakes 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.
PMID: 27046159DERIVEDYeh 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.
PMID: 27022822DERIVEDMeredith 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.
PMID: 26994121DERIVEDHermiller 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.
PMID: 26793956DERIVEDMauri 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.
PMID: 26586780DERIVEDKereiakes 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.
PMID: 26493248DERIVEDYeh 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.
PMID: 25787199DERIVEDKereiakes 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; Dual Antiplatelet Therapy (DAPT) Study Investigators. Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial. JAMA. 2015 Mar 17;313(11):1113-21. doi: 10.1001/jama.2015.1671.
PMID: 25781440DERIVEDYeh RW, Czarny MJ, Normand SL, Kereiakes DJ, Holmes DR Jr, Brindis RG, Weaver WD, Rumsfeld JS, Roe MT, Kim S, Driscoll-Shempp P, Mauri L. Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):96-102. doi: 10.1161/CIRCOUTCOMES.114.001239. Epub 2014 Nov 16.
PMID: 25399847DERIVEDMauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16.
PMID: 25399658DERIVEDMatteau A, Yeh RW, Kereiakes D, Orav EJ, Massaro J, Steg PG, Normand SL, Cutlip DE, Mauri L. Frequency of the use of low- versus high-dose aspirin in dual antiplatelet therapy after percutaneous coronary intervention (from the Dual Antiplatelet Therapy study). Am J Cardiol. 2014 Apr 1;113(7):1146-52. doi: 10.1016/j.amjcard.2013.10.015. Epub 2013 Nov 8.
PMID: 24332248DERIVEDMauri L, Kereiakes DJ, Normand SL, Wiviott SD, Cohen DJ, Holmes DR, Bangalore S, Cutlip DE, Pencina M, Massaro JM. Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, 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. Am Heart J. 2010 Dec;160(6):1035-41, 1041.e1. doi: 10.1016/j.ahj.2010.07.038.
PMID: 21146655DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Priscilla Driscoll Shempp, Sr. Director Trial Design, Development and Strategy
- Organization
- Harvard Clinical Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Mauri, MD, MSc
Brigham and Women's Hospital
- PRINCIPAL INVESTIGATOR
Dean Kereiakes, MD, FACC
Christ Hospital Heart and Vascular Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2009
First Posted
September 16, 2009
Study Start
October 1, 2009
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 9, 2017
Results First Posted
October 22, 2015
Record last verified: 2017-05