The Dual Antiplatelet Therapy Study (DAPT Study)
This study is ongoing, but not recruiting participants.
Sponsor:
Harvard Clinical Research Institute
Collaborators:
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis Corporation
Eli Lilly and Company
Daiichi Sankyo Inc.
Medtronic
Information provided by:
Harvard Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT00977938
First received: September 14, 2009
Last updated: July 22, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Placebo & Aspirin Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions |
Resource links provided by NLM:
Further study details as provided by Harvard Clinical Research Institute:
Primary Outcome Measures:
- Incidence of composite of all death, myocardial infarction (MI) and stroke (defined as MACCE) [ Time Frame: 21 months (12-33 months post-index procedure) ] [ Designated as safety issue: No ]
- Incidence of stent thrombosis (ST) [ Time Frame: 21 months (12-33 months post-index procedure) ] [ Designated as safety issue: No ]
- Incidence of major bleeding [ Time Frame: 21 months (12-33 months post-index procedure) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20645 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria (Enrollment):
- Subject is > 18 years of age.
- Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
- Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
- The subject has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent will be valid for the duration of the trial or until the subject withdraws.
Inclusion Criterion (Randomization at 12 months):
1. Subject, at 12 months, is free from death, MI, stroke, repeat coronary revascularization, major bleeding, and stent thrombosis and has been compliant with dual antiplatelet therapy following stent implantation.
Exclusion Criteria (Enrollment):
- Index procedure stent placement with stent diameter <2.25 mm or >4.0 mm.
- Pregnant women.
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment.
- Current medical condition with a life expectancy of less than 3 years.
- Concurrent enrollment in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a DES or BMS other than those included as DAPT Study devices. The subject may only be enrolled in the DAPT Study once.
- Subjects on warfarin or similar anticoagulant therapy.
- Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted.
- Subjects unable to give informed consent.
- Subject treated with both DES and BMS during the index procedure.
Exclusion Criteria (Randomization at 12 months):
- Pregnant women.
- Subject switched thienopyridine type or dose within 6 months prior to randomization.
- Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
- Current medical condition with a life expectancy of less than 3 years.
- Subjects on warfarin or similar anticoagulant therapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977938
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| United States, Alabama | |
| Thomas Hospital | |
| Fairhope, Alabama, United States, 36532 | |
| United States, Arizona | |
| Mercy Gilbert Medical Center | |
| Gilbert, Arizona, United States, 85297 | |
| Heart & Vascular Center of Arizona | |
| Phoenix, Arizona, United States, 85006 | |
| Scottsdale Health Care | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, Arkansas | |
| NEA Baptist Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| Arkansas Heart Hospital | |
| Little Rock, Arkansas, United States, 72211 | |
| University of Arkansas (Central VA) for Medical Science | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| California Cardiovascular Consultants/ Washington Hospital | |
| Fremont, California, United States, 94538 | |
| The Foundation for Cardiovascular Medicine | |
| La Jolla, California, United States, 92037 | |
| Mercy General Hospital | |
| Sacramento, California, United States, 95819 | |
| UC San Diego Medical Center | |
| San Diego, California, United States, 92103-8784 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| St. Joseph's Medical Center- CA | |
| Stockton, California, United States, 95204-6088 | |
| Torrance Memorial Medical Center / Vasek Polak Research Program | |
| Torrance, California, United States, 90505 | |
| Harbor - UCLA Medical Center | |
| Torrance, California, United States, 90509 | |
| United States, Colorado | |
| Medical Center of Aurora | |
| Aurora, Colorado, United States, 80012 | |
| United States, Connecticut | |
| Bridgeport Hospital | |
| Bridgeport, Connecticut, United States, 06610 | |
| Connecticut Clinical Research, LLC | |
| Bridgeport, Connecticut, United States, 06606 | |
| St. Vincent's Medical Center | |
| Stamford, Connecticut, United States, 06905 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Palm Beach Heart Research Institute | |
| Atlantis, Florida, United States, 33462 | |
| Bay Area Cardiology Associates/ Brandon Regional Hospital | |
| Brandon, Florida, United States, 33511 | |
| Jacksonville Heart Center | |
| Jacksonville, Florida, United States, 32207 | |
| Watson Clinic Center for Research | |
| Lakeland, Florida, United States, 33805 | |
| Diagnostic Cardiology Associates | |
| Lauderdale Lakes, Florida, United States, 33313 | |
| Melbourne Internal Medicine Assoc | |
| Melbourne, Florida, United States, 32901 | |
| Baptist Hospital of Miami | |
| Miami, Florida, United States, 33176 | |
| Munroe Regional Medical Center | |
| Ocala, Florida, United States, 34471 | |
| Ocala Regional Medical Center | |
| Ocala, Florida, United States, 34480 | |
| Florida Hospital | |
| Orlando, Florida, United States, 32803 | |
| Sacred Heart Hospital | |
| Pensacola, Florida, United States, 32504 | |
| Baptist Hospital | |
| Pensacola, Florida, United States, 32501 | |
| Tallahassee Memorial Hospital | |
| Tallahassee, Florida, United States, 32308 | |
| Pepin Heart Hospital | |
| Tampa, Florida, United States, 33613 | |
| Winter Haven Hospital | |
| Winter Haven, Florida, United States, 33881 | |
| United States, Georgia | |
| Emory University Hospital Midtown | |
| Atlanta, Georgia, United States, 30308 | |
| Piedmont Hospital Research Institute | |
| Atlanta, Georgia, United States, 30309 | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| Medical Center Central Georgia | |
| Macon, Georgia, United States, 31201 | |
| Redmond Regional Hospital | |
| Rome, Georgia, United States, 30165 | |
| United States, Illinois | |
| Advocate Good Shephard Hospital | |
| Barrington, Illinois, United States, 60010 | |
| Jesse Brown VA Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| Good Samaritan Hospital- IL | |
| Downers Grove, Illinois, United States, 60515 | |
| Elmhurst Memorial Hospital | |
| Elmhurst, Illinois, United States, 60126 | |
| Heartland Education and Research Foundation | |
| Joliet, Illinois, United States, 60435 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Heart Care Research Foundation | |
| Mokena, Illinois, United States, 60448 | |
| Edward Heart Hospital | |
| Naperville, Illinois, United States, 60540 | |
| United States, Indiana | |
| Midwest Cardiovascular Research and Education Foundation | |
| Elkhart, Indiana, United States, 46541 | |
| St. Vincent Heart Center of Indiana, LLC | |
| Indianapolis, Indiana, United States, 46290 | |
| Northwest Indiana Cardiovascular Physicians, P.C. | |
| Valparaiso, Indiana, United States, 46383 | |
| United States, Iowa | |
| McFarland Clinic PC | |
| Ames, Iowa, United States, 50010 | |
| St. Luke's Hospital - Cedar Rapids | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Iowa Heart Center | |
| West Des Moines, Iowa, United States, 50266 | |
| United States, Kentucky | |
| Kings Daughters Medical Center | |
| Ashland, Kentucky, United States, 41101 | |
| United States, Louisiana | |
| Tulane University Medical School | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Northeast Cardiology Associates | |
| Bangor, Maine, United States, 04401 | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Union Memorial Hospital | |
| Baltimore, Maryland, United States, 21218 | |
| Sinai Hospital at Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| Shah Associates, LLC | |
| Prince Frederick, Maryland, United States, 20678 | |
| Peninsula Regional Medical Center | |
| Salisbury, Maryland, United States, 21804 | |
| Washington Adventist Hospital | |
| Takoma Park, Maryland, United States, 20912 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02120 | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Lahey Clinic Medical Center | |
| Burlington, Massachusetts, United States, 01805 | |
| Cape Cod Hospital | |
| Hyannis, Massachusetts, United States, 02601 | |
| UMass Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Bay Regional Medical Center | |
| Bay City, Michigan, United States, 48708 | |
| Henry Ford Hospital Heart & Vascular Institute | |
| Detroit, Michigan, United States, 48202 | |
| Harper University Hospital | |
| Detroit, Michigan, United States, 48201-2018 | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States, 49048 | |
| St. Joseph Mercy-PTCMI | |
| Pontiac, Michigan, United States, 48341 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| Covenant Medical Center | |
| Saginaw, Michigan, United States, 48602 | |
| Great Lakes Heart & Vascular Institute, PC | |
| St. Joseph, Michigan, United States, 49085 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Beaumont Hospital Troy | |
| Troy, Michigan, United States, 48085 | |
| United States, Minnesota | |
| Mayo Clinic - Saint Marys Hospital | |
| Rochester, Minnesota, United States, 55905 | |
| Central Minnesota Heart Center at St. Cloud Hospital | |
| St. Cloud, Minnesota, United States, 56303 | |
| United States, Mississippi | |
| Hattiesburg Clinic | |
| Hattiesburg, Mississippi, United States, 39401 | |
| Cardiology Associates Research LLC | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Missouri | |
| St. Luke's Hospital Mid America Heart Institute | |
| Kansas City, Missouri, United States, 64111 | |
| Kansas City Heart Foundation | |
| Kansas City, Missouri, United States, 64114 | |
| North Kansas City Hospital | |
| North Kansas City, Missouri, United States, 64116 | |
| St. John's Medical Institute | |
| Springfield, Missouri, United States, 65807 | |
| St. Louis University Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| St. John's Mercy Medical Center | |
| St. Louis, Missouri, United States, 63141 | |
| Washington University Hospital | |
| St. Louis, Missouri, United States, 63110-1093 | |
| United States, Nebraska | |
| Nebraska Heart Institute | |
| Lincoln, Nebraska, United States, 68526 | |
| Alegent Health / Bergan Mercy Hospital | |
| Omaha, Nebraska, United States, 68124 | |
| Creighton University | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Hampshire | |
| Catholic Medical Center | |
| Manchester, New Hampshire, United States, 03102 | |
| United States, New Jersey | |
| Cooper University Hospital | |
| Camden, New Jersey, United States, 08103 | |
| Cardiovascular Associates of the Delaware Valley, PA | |
| Haddon Heights, New Jersey, United States, 08035 | |
| Hamilton Cardiology Associates | |
| Hamilton, New Jersey, United States, 08690 | |
| Valley Hospital | |
| Hawthorne, New Jersey, United States, 07506 | |
| UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08901 | |
| St. Michaels Hospital | |
| Newark, New Jersey, United States, 07102 | |
| United States, New Mexico | |
| Presbyterian Heart Group | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| SJH Cardiology Associates | |
| Liverpool, New York, United States, 13088 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| Hudson Valley Heart Center | |
| Poughkeepsie, New York, United States, 12601 | |
| Stony Brook University Medical Center | |
| Stony Brook, New York, United States, 11794-8167 | |
| St. Elizabeth's Medical Center- NY | |
| Utica, New York, United States, 13501 | |
| Westchester Medical Center | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Asheville Cardiology Associates | |
| Asheville, North Carolina, United States, 28802 | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Carolina Heart Specialists | |
| Gastonia, North Carolina, United States, 28054 | |
| Carolina Cardiology Associates | |
| High Point, North Carolina, United States, 27262 | |
| Wake Heart Association | |
| Raleigh, North Carolina, United States, 27610 | |
| Wake Forest Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157-1045 | |
| Forsyth Medical Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, North Dakota | |
| MeritCare Medical Center | |
| Fargo, North Dakota, United States, 58122 | |
| Altru Health System | |
| Grand Forks, North Dakota, United States, 58206 | |
| United States, Ohio | |
| The Lindner Clinical Trial Center | |
| Cincinnati, Ohio, United States, 45219 | |
| Good Samaritan Hospital | |
| Cincinnati, Ohio, United States, 45220 | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267-0542 | |
| Riverside Methodist | |
| Columbus, Ohio, United States, 43214 | |
| Elyria Memorial Hospital | |
| Elyria, Ohio, United States, 44035 | |
| Frederick C Smith Clinic dba Smith Clinic | |
| Marion, Ohio, United States, 43302 | |
| Northwest Ohio Cardiology | |
| Toledo, Ohio, United States, 43615 | |
| United States, Oklahoma | |
| Midwest Regional Medical Center | |
| Midwest City, Oklahoma, United States, 73110 | |
| Oklahoma Foundation for CV Research | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| St. Vincent Hospital/ Providence Heart Hospital | |
| Portland, Oregon, United States, 97225 | |
| Oregon Health & Sciences University Hospital | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Chambersburg Hospital | |
| Chambersburg, Pennsylvania, United States, 17201 | |
| Geisinger Clinic | |
| Danville, Pennsylvania, United States, 17822 | |
| Doylestown Hospital | |
| Doylestown, Pennsylvania, United States, 18901 | |
| Pinnacle Health Hospital | |
| Harrisburg, Pennsylvania, United States, 17110 | |
| Conemaugh Memorial Medical Center | |
| Johnstown, Pennsylvania, United States, 15905 | |
| UPMC Presbyterian Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Donald Guthrie Foundation for Education and Research | |
| Sayre, Pennsylvania, United States, 18840 | |
| Berks Cardiologists | |
| Wyomissing, Pennsylvania, United States, 19610 | |
| York Hospital (PA) | |
| York, Pennsylvania, United States, 17403 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Miriam Hospital | |
| Providence, Rhode Island, United States, 02904 | |
| United States, South Carolina | |
| AnMed Health | |
| Anderson, South Carolina, United States, 29621 | |
| United States, South Dakota | |
| Black Hills Research- Rapid City Regional | |
| Rapid City, South Dakota, United States, 57701 | |
| North Central Heart Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117 | |
| United States, Tennessee | |
| Chattanooga Heart Institute | |
| Chattanooga, Tennessee, United States, 37404 | |
| Chattanooga Heart - East Third Street | |
| Chattanooga, Tennessee, United States, 37404 | |
| Centennial Heart Medical Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Austin Heart | |
| Austin, Texas, United States, 78705 | |
| Texas Cardiovascular | |
| Austin, Texas, United States, 78758 | |
| Capital Cardiovascular Research Institute | |
| Austin, Texas, United States, 78745 | |
| CRSTI Research | |
| Dallas, Texas, United States, 75230 | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Veteran's Affairs Medical Center- Dallas | |
| Dallas, Texas, United States, 75216 | |
| Methodist DeBakey Heart & Vascular Center | |
| Houston, Texas, United States, 77030 | |
| North Dallas Research Associates | |
| McKinney, Texas, United States, 75069 | |
| North Dallas Research Associate | |
| McKinney, Texas, United States, 75069 | |
| The Heart Hospital / Baylor Plano | |
| Plano, Texas, United States, 75093 | |
| Scott and White Healthcare - Round Rock | |
| Round Rock, Texas, United States, 78665 | |
| TexSan Heart Hospital | |
| San Antonio, Texas, United States, 78229 | |
| Mother Frances Hospital | |
| Tyler, Texas, United States, 75701 | |
| Providence Healthcare Network | |
| Waco, Texas, United States, 76712 | |
| United States, Utah | |
| Intermountain Medical Center | |
| Murray, Utah, United States, 84157-7000 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Rockingham Memorial Hospital | |
| Harrisonburg, Virginia, United States, 22801 | |
| Lynchburg General Hospital | |
| Lynchburg, Virginia, United States, 24501 | |
| Sentara, Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23507 | |
| Carilion Clinic | |
| Roanoke, Virginia, United States, 24014 | |
| Cardiovascular Associates, Ltd. | |
| Virginia Beach, Virginia, United States, 23454 | |
| Winchester Medical Center | |
| Winchester, Virginia, United States, 22601 | |
| United States, Washington | |
| Providence St. Peter Hospital | |
| Olympia, Washington, United States, 98506 | |
| University of Washington | |
| Seattle, Washington, United States, 98195-8422 | |
| Inland Cardiology Associates | |
| Spokane, Washington, United States, 99204 | |
| Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Aurora St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| CaRE Foundation, Inc. | |
| Wausau, Wisconsin, United States, 54401 | |
| Australia, New South Wales | |
| St. Vincents Hospital Sydney | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Prince of Wales Eastern Heart | |
| Randwick, New South Wales, Australia, 2031 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| The Alfred Hospital | |
| Prahran, Victoria, Australia, 3004 | |
| Australia, Western Australia | |
| Fremantle Hospital | |
| Fremantle, Western Australia, Australia, 6160 | |
| The Mount Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| Australia | |
| Monash Heart | |
| Clayton, Australia, 3168 | |
| St Vincents Hospital Melbourne | |
| Fitzroy, Australia, 3065 | |
| Czech Republic | |
| Fakultni nemocnice Hradec Kralove | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Krajska karlovarska nemocnice a.s. | |
| Karlovy Vary, Czech Republic, 360 66 | |
| Centrum pro choroby srdce a cev | |
| Kromeriz, Czech Republic, 767 01 | |
| Mestska nemocnice Ostrava | |
| Ostrava, Czech Republic, 701 00 | |
| Krajska nemocnice T. Bati a.s. | |
| Zlin, Czech Republic, 76275 | |
| France | |
| Centre Hospitalier Saint Louis | |
| La Rochelle, France, 17000 | |
| Hospital Saint Philibert | |
| Lomme, France, 59462 | |
| Nouvelles Cliniques Nantaises | |
| Nantes, France, 44277 | |
| Clinique les Franciscaines | |
| Nimes, France, 30000 | |
| Hopital Bichat | |
| Paris, France, 75018 | |
| Groupe Hospitalier Sud | |
| Pessac, France, 33604 | |
| CH Chatiliez Tourcoing | |
| Tourcoing, France, 59208 | |
| Germany | |
| Helios Klinikum Emil von Behring | |
| Berlin, BE, Germany, 1 | |
| Universitaetsklinikum Schleswig-Holstein - PS | |
| Luebeck, SH, Germany, 23538 | |
| Vivantes Klinikum im Friedrichshain | |
| Berlin, Germany, 10249 | |
| Vivantes-Klinikum Neukoelln | |
| Berlin, Germany, 13437 | |
| Vivantes-Klinikum Neukoelin | |
| Berlin, Germany, 12351 | |
| Vivantes-Humboldt Klinikum | |
| Berlin, Germany, 13509 | |
| Elbe-Kliniken Stade-Buxtehude GmbH | |
| Buxtehude, Germany, 21614 | |
| Universitaetsklinikum Dresden | |
| Dresden, Germany, 01307 | |
| Asklepios Klinik St. Georg | |
| Hamburg, Germany, 20099 | |
| Herzzentrum Leipzig GmbH | |
| Leipzig, Germany, 4289 | |
| Elbe-Kliniken Stade-Buxtehude GmbH | |
| Stade, Germany, 21682 | |
| Hungary | |
| Gottsegen Gyorgy Orszagos Kardiologiai Intezet | |
| Budapest, Hungary, 1096 | |
| Josa Andras Oktato Korhaz Nonprofit Kft | |
| Nyiregyhaza, Hungary, 4400 | |
| Pecsi Tudomanyegyetem Klinikai Kozpont | |
| Pecs, Hungary | |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont | |
| Szeged, Hungary, 6720 | |
| Zala Megyei Korhaz | |
| Zalaegerszeg, Hungary, 8900 | |
| New Zealand | |
| Mercy Angiography | |
| Epsom, Auckland, New Zealand, 00000 | |
| North Shore Hospital | |
| Auckland, New Zealand, 0622 | |
| Middlemore Hospital | |
| Auckland, New Zealand | |
| Ascot Hospital | |
| Auckland, New Zealand | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 8001 | |
| Waikato Hospital | |
| Hamilton, New Zealand, 3240 | |
| Nelson Hospital | |
| Nelson, New Zealand | |
| Wakefield Hospital | |
| Wellington, New Zealand, 6039 | |
| Wellington Hospital | |
| Wellington, New Zealand, 6021 | |
| Poland | |
| Uniwersyteck Szpital Klin. w Bialymstoku | |
| Bialystok, Poland, 15-276 | |
| Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ | |
| Bydgoszcz, Poland, 85-826 | |
| NZOZ Centrum Medyczne Beluga-Med | |
| Krakow, Poland, 30-069 | |
| Szpital Uniwersytecki w Krakowie | |
| Krakow, Poland, 31-501 | |
| SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie | |
| Szczecin, Poland, 70-111 | |
| Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S | |
| Ustron, Poland, 43-450 | |
| Instytut Kardiologii im. Kardynala St. Wyszynskiego | |
| Warszawa, Poland, 04-637 | |
| Romania | |
| Spitalul Clinic de Urgenta Bucuresti | |
| Bucuresti, Romania, 14461 | |
| Spitalul Clinic Universitar de Urgenta Bucuresti | |
| Bucuresti, Romania, 50098 | |
| Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu | |
| Bucuresti, Romania, 22328 | |
| Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei | |
| Bucuresti, Romania, 10242 | |
| Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr. | |
| Bucuresti, Romania, 22328 | |
| Institutul Inimii Niculae Stancioiu Cluj-Napoca | |
| Cluj-Napoca, Romania, 400001 | |
| Institutul de Boli Cardiovasculare si Transplant Targu Mures | |
| Targu Mures, Romania, 540136 | |
| United Kingdom | |
| Wycombe General Hospital | |
| High Wycombe, Bucks, United Kingdom, HP11 2TT | |
| Papworth Hospital | |
| Cambridge, Cambs, United Kingdom, CB3 8RE | |
| Torbay hospital | |
| Torquay, Devon, United Kingdom, TQ2 7AA | |
| Royal Bournemouth General Hospital | |
| Bournemouth, Dorset, United Kingdom, BH7 7DW | |
| Basildon University Hospital | |
| Basildon, Essex, United Kingdom, SS16 5NL | |
| Barnet Hospital | |
| Barnet, Herts, United Kingdom, EN5 3DJ | |
| James Cook Hospital | |
| Middlesborough, N York, United Kingdom, TS4 3BW | |
| Ninewells Hospital | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Weston General Hospital | |
| Weston Super Mare, Somerset, United Kingdom, BS23 4TQ | |
| Golden Jubilee National Hospital | |
| Glasgow, Strath, United Kingdom, F81 4HX | |
| St Peter's Hospital | |
| Chertsey, United Kingdom, KT16 OPZ | |
| University Hospital of Coventry and Warwickshire | |
| Coventry, United Kingdom, CV2 2DX | |
| Ninewells Hospital | |
| Dundee, United Kingdom, DD1 9SY | |
| Royal Infirmary of Edinburgh | |
| Edinburgh, United Kingdom, EH16 4SA | |
| University Hospital of Leicester Glenfield Hospital | |
| Leicester, United Kingdom, LE3 9QP | |
| The London Chest Hospital | |
| London, United Kingdom, E2 9JX | |
| Freeman Hospital | |
| Newcastle, United Kingdom, NE7 7AW | |
| Derriford Hospital | |
| Plymouth, United Kingdom, PL6 8DH | |
Sponsors and Collaborators
Harvard Clinical Research Institute
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis Corporation
Eli Lilly and Company
Daiichi Sankyo Inc.
Medtronic
Investigators
| Principal Investigator: | Laura Mauri, MD, MSc | Brigham and Women's Hospital |
| Principal Investigator: | Dean Kereiakes, MD, FACC | Christ Hospital Heart and Vascular Center |
More Information
No publications provided by Harvard Clinical Research Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Laura Mauri, MD, Chief Scientific Officer, Harvard Clinical Research Institute |
| ClinicalTrials.gov Identifier: | NCT00977938 History of Changes |
| Other Study ID Numbers: | HCRIG080186 |
| Study First Received: | September 14, 2009 |
| Last Updated: | July 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Harvard Clinical Research Institute:
|
Acute Coronary Syndrome Adverse event Antiplatelet therapy Sirolimus Everolimus Paclitaxel Zotarolimus Bare Metal Stent Drug Eluting Stent Clinical Events Committee Dual antiplatelet therapy |
Harvard Clinical Research Institute Major Adverse Cardiac and Cerebral Event Major Bleeding Myocardial infarction Myocardial ischemia Percutaneous coronary intervention Stent placement Stent Thrombosis Thienopyridine Clopidogrel Prasugrel |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Clopidogrel Prasugrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |
ClinicalTrials.gov processed this record on June 17, 2013