The Dual Antiplatelet Therapy Study (DAPT Study)

May 10, 2017 updated by: Baim Institute for Clinical Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25682

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (Enrollment):

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

Inclusion Criterion (Randomization at 12 months):

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

Exclusion Criteria (Enrollment):

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

Exclusion Criteria (Randomization at 12 months):

  1. Pregnant women.
  2. Subject switched thienopyridine type or dose within 6 months prior to randomization.
  3. Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
  4. Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
  5. Current medical condition with a life expectancy of less than 3 years.
  6. Subjects on warfarin or similar anticoagulant therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 12m DAPT Study Arm
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.
Drug: Placebo & Aspirin
Active Comparator: 30m DAPT Study Arm
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine treatment in addition to aspirin.
Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
Time Frame: 18 months (12-30 months post-index procedure)
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
Time Frame: 18 months (12-30 months post-index procedure)
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
Time Frame: 18 months (12-30 months post-index procedure)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS
Time Frame: 33 months (0-33 months post-index procedure)
Secondary powered endpoint
33 months (0-33 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS
Time Frame: 33 months (0-33 months post-index procedure)
Secondary powered endpoint
33 months (0-33 months post-index procedure)
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
Time Frame: 21 months (12-33 months post-index procedure)
21 months (12-33 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
Time Frame: 21 months (12-33 months post-index procedure)
ST was assessed according to the Academic Research Consortium (ARC) definitions.
21 months (12-33 months post-index procedure)
GUSTO Severe or Moderate Bleeding - Randomized DES ITT
Time Frame: 21 months (12-33 months post-index procedure)
Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
21 months (12-33 months post-index procedure)
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
Time Frame: 18 months (12-30 months post-index procedure)
18 months (12-30 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
Time Frame: 18 months (12-30 months post-index 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 BMS ITT
Time Frame: 18 months (12-30 months post-index 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)
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
Time Frame: 21 months (12-33 months post-index procedure)
21 months (12-33 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
Time Frame: 21 months (12-33 months post-index procedure)
ST was assessed according to the Academic Research Consortium (ARC) definitions.
21 months (12-33 months post-index procedure)
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
Time Frame: 21 months (12-33 months post-index procedure)
Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
21 months (12-33 months post-index procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baim Institute for Clinical Research

Collaborators

Bristol-Myers Squibb
Eli Lilly and Company
Daiichi Sankyo, Inc.
Boston Scientific Corporation
Medtronic
Abbott
Cordis Corporation
Sanofi-Synthelabo

Investigators

  • Principal Investigator: Laura Mauri, MD, MSc, Brigham and Women's Hospital
  • Principal Investigator: Dean Kereiakes, MD, FACC, Christ Hospital Heart and Vascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 15, 2009

First Posted (Estimate)

September 16, 2009

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCRIG080186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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