The Dual Antiplatelet Therapy Study (DAPT Study)

NCT ID: NCT00977938

Last Updated: 2017-06-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25682 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo & Aspirin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Clopidogrel & Aspirin, Prasugrel & Aspirin

Intervention Type DRUG

Interventions

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Placebo & Aspirin

Intervention Type DRUG

Clopidogrel & Aspirin, Prasugrel & Aspirin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.


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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Sanofi-Synthelabo

INDUSTRY

Sponsor Role collaborator

Cordis Corporation

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

Baim Institute for Clinical Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Mauri, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Dean Kereiakes, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Christ Hospital Heart and Vascular Center

Locations

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Thomas Hospital

Fairhope, Alabama, United States

Site Status

Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Site Status

Heart & Vascular Center of Arizona

Phoenix, Arizona, United States

Site Status

Scottsdale Health Care

Scottsdale, Arizona, United States

Site Status

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Site Status

University of Arkansas (Central VA) for Medical Science

Little Rock, Arkansas, United States

Site Status

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Site Status

California Cardiovascular Consultants/ Washington Hospital

Fremont, California, United States

Site Status

The Foundation for Cardiovascular Medicine

La Jolla, California, United States

Site Status

Mercy General Hospital

Sacramento, California, United States

Site Status

UC San Diego Medical Center

San Diego, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

St. Joseph's Medical Center- CA

Stockton, California, United States

Site Status

Torrance Memorial Medical Center / Vasek Polak Research Program

Torrance, California, United States

Site Status

Harbor - UCLA Medical Center

Torrance, California, United States

Site Status

Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Connecticut Clinical Research, LLC

Bridgeport, Connecticut, United States

Site Status

Bridgeport Hospital

Bridgeport, Connecticut, United States

Site Status

St. Vincent's Medical Center

Stamford, Connecticut, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Palm Beach Heart Research Institute

Atlantis, Florida, United States

Site Status

Bay Area Cardiology Associates/ Brandon Regional Hospital

Brandon, Florida, United States

Site Status

Jacksonville Heart Center

Jacksonville, Florida, United States

Site Status

Watson Clinic Center for Research

Lakeland, Florida, United States

Site Status

Diagnostic Cardiology Associates

Lauderdale Lakes, Florida, United States

Site Status

Melbourne Internal Medicine Assoc

Melbourne, Florida, United States

Site Status

Baptist Hospital of Miami

Miami, Florida, United States

Site Status

Munroe Regional Medical Center

Ocala, Florida, United States

Site Status

Ocala Regional Medical Center

Ocala, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

Baptist Hospital

Pensacola, Florida, United States

Site Status

Sacred Heart Hospital

Pensacola, Florida, United States

Site Status

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Site Status

Pepin Heart Hospital

Tampa, Florida, United States

Site Status

Winter Haven Hospital

Winter Haven, Florida, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Piedmont Hospital Research Institute

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Medical Center Central Georgia

Macon, Georgia, United States

Site Status

Redmond Regional Hospital

Rome, Georgia, United States

Site Status

Advocate Good Shephard Hospital

Barrington, Illinois, United States

Site Status

Jesse Brown VA Medical Center

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Good Samaritan Hospital- IL

Downers Grove, Illinois, United States

Site Status

Elmhurst Memorial Hospital

Elmhurst, Illinois, United States

Site Status

Heartland Education and Research Foundation

Joliet, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Heart Care Research Foundation

Mokena, Illinois, United States

Site Status

Edward Heart Hospital

Naperville, Illinois, United States

Site Status

Midwest Cardiovascular Research and Education Foundation

Elkhart, Indiana, United States

Site Status

St. Vincent Heart Center of Indiana, LLC

Indianapolis, Indiana, United States

Site Status

Northwest Indiana Cardiovascular Physicians, P.C.

Valparaiso, Indiana, United States

Site Status

McFarland Clinic PC

Ames, Iowa, United States

Site Status

St. Luke's Hospital - Cedar Rapids

Cedar Rapids, Iowa, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

Kings Daughters Medical Center

Ashland, Kentucky, United States

Site Status

Tulane University Medical School

New Orleans, Louisiana, United States

Site Status

Northeast Cardiology Associates

Bangor, Maine, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

Sinai Hospital at Baltimore

Baltimore, Maryland, United States

Site Status

Union Memorial Hospital

Baltimore, Maryland, United States

Site Status

Shah Associates, LLC

Prince Frederick, Maryland, United States

Site Status

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Site Status

Washington Adventist Hospital

Takoma Park, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Site Status

Cape Cod Hospital

Hyannis, Massachusetts, United States

Site Status

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

Bay Regional Medical Center

Bay City, Michigan, United States

Site Status

Harper University Hospital

Detroit, Michigan, United States

Site Status

Henry Ford Hospital Heart & Vascular Institute

Detroit, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

St. Joseph Mercy-PTCMI

Pontiac, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Covenant Medical Center

Saginaw, Michigan, United States

Site Status

Great Lakes Heart & Vascular Institute, PC

Saint Joseph, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

Beaumont Hospital Troy

Troy, Michigan, United States

Site Status

Mayo Clinic - Saint Marys Hospital

Rochester, Minnesota, United States

Site Status

Central Minnesota Heart Center at St. Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Site Status

Cardiology Associates Research LLC

Tupelo, Mississippi, United States

Site Status

St. Luke's Hospital Mid America Heart Institute

Kansas City, Missouri, United States

Site Status

Kansas City Heart Foundation

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

North Kansas City, Missouri, United States

Site Status

St. John's Medical Institute

Springfield, Missouri, United States

Site Status

Washington University Hospital

St Louis, Missouri, United States

Site Status

St. Louis University Hospital

St Louis, Missouri, United States

Site Status

St. John's Mercy Medical Center

St Louis, Missouri, United States

Site Status

Nebraska Heart Institute

Lincoln, Nebraska, United States

Site Status

Alegent Health / Bergan Mercy Hospital

Omaha, Nebraska, United States

Site Status

Creighton University

Omaha, Nebraska, United States

Site Status

Catholic Medical Center

Manchester, New Hampshire, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

Cardiovascular Associates of the Delaware Valley, PA

Haddon Heights, New Jersey, United States

Site Status

Hamilton Cardiology Associates

Hamilton, New Jersey, United States

Site Status

Valley Hospital

Hawthorne, New Jersey, United States

Site Status

UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

St. Michaels Hospital

Newark, New Jersey, United States

Site Status

Presbyterian Heart Group

Albuquerque, New Mexico, United States

Site Status

SJH Cardiology Associates

Liverpool, New York, United States

Site Status

Winthrop University Hospital

Mineola, New York, United States

Site Status

Hudson Valley Heart Center

Poughkeepsie, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

St. Elizabeth's Medical Center- NY

Utica, New York, United States

Site Status

Westchester Medical Center

Valhalla, New York, United States

Site Status

Asheville Cardiology Associates

Asheville, North Carolina, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Carolina Heart Specialists

Gastonia, North Carolina, United States

Site Status

Carolina Cardiology Associates

High Point, North Carolina, United States

Site Status

Wake Heart Association

Raleigh, North Carolina, United States

Site Status

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Site Status

MeritCare Medical Center

Fargo, North Dakota, United States

Site Status

Altru Health System

Grand Forks, North Dakota, United States

Site Status

The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

Site Status

Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Riverside Methodist

Columbus, Ohio, United States

Site Status

Elyria Memorial Hospital

Elyria, Ohio, United States

Site Status

Frederick C Smith Clinic dba Smith Clinic

Marion, Ohio, United States

Site Status

Northwest Ohio Cardiology

Toledo, Ohio, United States

Site Status

Midwest Regional Medical Center

Midwest City, Oklahoma, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Foundation for CV Research

Oklahoma City, Oklahoma, United States

Site Status

St. Vincent Hospital/ Providence Heart Hospital

Portland, Oregon, United States

Site Status

Oregon Health & Sciences University Hospital

Portland, Oregon, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Site Status

Geisinger Clinic

Danville, Pennsylvania, United States

Site Status

Doylestown Hospital

Doylestown, Pennsylvania, United States

Site Status

Pinnacle Health Hospital

Harrisburg, Pennsylvania, United States

Site Status

Conemaugh Memorial Medical Center

Johnstown, Pennsylvania, United States

Site Status

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Donald Guthrie Foundation for Education and Research

Sayre, Pennsylvania, United States

Site Status

Berks Cardiologists

Wyomissing, Pennsylvania, United States

Site Status

York Hospital (PA)

York, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Miriam Hospital

Providence, Rhode Island, United States

Site Status

AnMed Health

Anderson, South Carolina, United States

Site Status

Black Hills Research- Rapid City Regional

Rapid City, South Dakota, United States

Site Status

North Central Heart Institute

Sioux Falls, South Dakota, United States

Site Status

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Site Status

Chattanooga Heart - East Third Street

Chattanooga, Tennessee, United States

Site Status

Chattanooga Heart Institute

Chattanooga, Tennessee, United States

Site Status

Centennial Heart Medical Center

Nashville, Tennessee, United States

Site Status

Austin Heart

Austin, Texas, United States

Site Status

Capital Cardiovascular Research Institute

Austin, Texas, United States

Site Status

Texas Cardiovascular

Austin, Texas, United States

Site Status

Veteran's Affairs Medical Center- Dallas

Dallas, Texas, United States

Site Status

CRSTI Research

Dallas, Texas, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Methodist DeBakey Heart & Vascular Center

Houston, Texas, United States

Site Status

North Dallas Research Associates

McKinney, Texas, United States

Site Status

North Dallas Research Associate

McKinney, Texas, United States

Site Status

The Heart Hospital / Baylor Plano

Plano, Texas, United States

Site Status

Scott and White Healthcare - Round Rock

Round Rock, Texas, United States

Site Status

TexSan Heart Hospital

San Antonio, Texas, United States

Site Status

Mother Frances Hospital

Tyler, Texas, United States

Site Status

Providence Healthcare Network

Waco, Texas, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Rockingham Memorial Hospital

Harrisonburg, Virginia, United States

Site Status

Lynchburg General Hospital

Lynchburg, Virginia, United States

Site Status

Sentara, Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

Carilion Clinic

Roanoke, Virginia, United States

Site Status

Cardiovascular Associates, Ltd.

Virginia Beach, Virginia, United States

Site Status

Winchester Medical Center

Winchester, Virginia, United States

Site Status

Providence St. Peter Hospital

Olympia, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Inland Cardiology Associates

Spokane, Washington, United States

Site Status

Sacred Heart Medical Center

Spokane, Washington, United States

Site Status

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

CaRE Foundation, Inc.

Wausau, Wisconsin, United States

Site Status

St. Vincents Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status

Prince of Wales Eastern Heart

Randwick, New South Wales, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

The Alfred Hospital

Prahran, Victoria, Australia

Site Status

Fremantle Hospital

Fremantle, Western Australia, Australia

Site Status

The Mount Hospital

Nedlands, Western Australia, Australia

Site Status

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

Monash Heart

Clayton, , Australia

Site Status

St Vincents Hospital Melbourne

Fitzroy, , Australia

Site Status

Fakultni nemocnice Hradec Kralove

Hradec KrƔlovƩ, , Czechia

Site Status

Krajska karlovarska nemocnice a.s.

Karlovy Vary, , Czechia

Site Status

Centrum pro choroby srdce a cev

Kroměříž, , Czechia

Site Status

Mestska nemocnice Ostrava

Ostrava, , Czechia

Site Status

Krajska nemocnice T. Bati a.s.

ZlĆ­n, , Czechia

Site Status

Centre Hospitalier Saint Louis

La Rochelle, , France

Site Status

Hospital Saint Philibert

Lomme, , France

Site Status

Nouvelles Cliniques Nantaises

Nantes, , France

Site Status

Clinique les Franciscaines

NƮmes, , France

Site Status

Hopital Bichat

Paris, , France

Site Status

Groupe Hospitalier Sud

Pessac, , France

Site Status

CH Chatiliez Tourcoing

Tourcoing, , France

Site Status

Universitaetsklinikum Schleswig-Holstein - PS

Lübeck, Schleswig-Holstein, Germany

Site Status

Helios Klinikum Emil von Behring

Berlin, State of Berlin, Germany

Site Status

Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Site Status

Vivantes-Klinikum Neukoelin

Berlin, , Germany

Site Status

Vivantes-Klinikum Neukoelln

Berlin, , Germany

Site Status

Vivantes-Humboldt Klinikum

Berlin, , Germany

Site Status

Elbe-Kliniken Stade-Buxtehude GmbH

Buxtehude, , Germany

Site Status

Universitaetsklinikum Dresden

Dresden, , Germany

Site Status

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Site Status

Elbe-Kliniken Stade-Buxtehude GmbH

Stade, , Germany

Site Status

Gottsegen Gyorgy Orszagos Kardiologiai Intezet

Budapest, , Hungary

Site Status

Josa Andras Oktato Korhaz Nonprofit Kft

NyƭregyhƔza, , Hungary

Site Status

Pecsi Tudomanyegyetem Klinikai Kozpont

PƩcs, , Hungary

Site Status

Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont

Szeged, , Hungary

Site Status

Zala Megyei Korhaz

Zalaegerszeg, , Hungary

Site Status

Mercy Angiography

Epsom, Auckland, New Zealand

Site Status

North Shore Hospital

Auckland, , New Zealand

Site Status

Ascot Hospital

Auckland, , New Zealand

Site Status

Middlemore Hospital

Auckland, , New Zealand

Site Status

Christchurch Hospital

Christchurch, , New Zealand

Site Status

Waikato Hospital

Hamilton, , New Zealand

Site Status

Nelson Hospital

Nelson, , New Zealand

Site Status

Wellington Hospital

Wellington, , New Zealand

Site Status

Wakefield Hospital

Wellington, , New Zealand

Site Status

Uniwersyteck Szpital Klin. w Bialymstoku

Bialystok, , Poland

Site Status

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

Bydgoszcz, , Poland

Site Status

NZOZ Centrum Medyczne Beluga-Med

Krakow, , Poland

Site Status

Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Site Status

SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

Szczecin, , Poland

Site Status

Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S

Ustroń, , Poland

Site Status

Instytut Kardiologii im. Kardynala St. Wyszynskiego

Warsaw, , Poland

Site Status

Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei

Bucharest, , Romania

Site Status

Spitalul Clinic de Urgenta Bucuresti

Bucharest, , Romania

Site Status

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

Bucharest, , Romania

Site Status

Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.

Bucharest, , Romania

Site Status

Spitalul Clinic Universitar de Urgenta Bucuresti

Bucharest, , Romania

Site Status

Institutul Inimii Niculae Stancioiu Cluj-Napoca

Cluj-Napoca, , Romania

Site Status

Institutul de Boli Cardiovasculare si Transplant Targu Mures

Târgu Mureş, , Romania

Site Status

Wycombe General Hospital

High Wycombe, Bucks, United Kingdom

Site Status

Papworth Hospital

Cambridge, Cambs, United Kingdom

Site Status

Torbay hospital

Torquay, Devon, United Kingdom

Site Status

Royal Bournemouth General Hospital

Bournemouth, Dorset, United Kingdom

Site Status

Basildon University Hospital

Basildon, Essex, United Kingdom

Site Status

Barnet Hospital

Barnet, Herts, United Kingdom

Site Status

James Cook Hospital

Middlesbrough, N York, United Kingdom

Site Status

Ninewells Hospital

Dundee, Scotland, United Kingdom

Site Status

Weston General Hospital

Weston-super-Mare, Somerset, United Kingdom

Site Status

Golden Jubilee National Hospital

Glasgow, Strath, United Kingdom

Site Status

St Peter's Hospital

Chertsey, , United Kingdom

Site Status

University Hospital of Coventry and Warwickshire

Coventry, , United Kingdom

Site Status

Ninewells Hospital

Dundee, , United Kingdom

Site Status

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status

University Hospital of Leicester Glenfield Hospital

Leicester, , United Kingdom

Site Status

The London Chest Hospital

London, , United Kingdom

Site Status

Freeman Hospital

Newcastle, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Countries

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United States Australia Czechia France Germany Hungary New Zealand Poland Romania United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37449567 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32683645 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31653353 (View on PubMed)

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.

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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.

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PMID: 29073947 (View on PubMed)

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.

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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.

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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.

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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.

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PMID: 27046159 (View on PubMed)

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.

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PMID: 27022822 (View on PubMed)

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.

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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.

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PMID: 26793956 (View on PubMed)

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.

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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.

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PMID: 26493248 (View on PubMed)

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.

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PMID: 25787199 (View on PubMed)

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; 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.

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PMID: 25781440 (View on PubMed)

Yeh 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.

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PMID: 25399847 (View on PubMed)

Mauri 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.

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PMID: 25399658 (View on PubMed)

Matteau 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.

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Mauri 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.

Reference Type DERIVED
PMID: 21146655 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HCRIG080186

Identifier Type: -

Identifier Source: org_study_id

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