The Dual Antiplatelet Therapy Study (DAPT Study)
- Conditions
- Coronary Artery Disease
- Interventions
- Registration Number
- NCT00977938
- Lead Sponsor
- Baim Institute for Clinical Research
- Brief Summary
The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25682
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12m DAPT Study Arm Placebo & Aspirin This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin. 30m DAPT Study Arm Clopidogrel & Aspirin, Prasugrel & Aspirin This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine treatment in addition to aspirin.
- Primary Outcome Measures
Name Time Method MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT 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.
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT 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.
GUSTO Severe or Moderate Bleeding - Randomized DES ITT 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.
- Secondary Outcome Measures
Name Time Method MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS 33 months (0-33 months post-index procedure) Secondary powered endpoint
Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS 33 months (0-33 months post-index procedure) Secondary powered endpoint
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT 21 months (12-33 months post-index procedure) Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT 21 months (12-33 months post-index procedure) ST was assessed according to the Academic Research Consortium (ARC) definitions.
GUSTO Severe or Moderate Bleeding - Randomized DES ITT 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.
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT 21 months (12-33 months post-index procedure) Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT 21 months (12-33 months post-index procedure) ST was assessed according to the Academic Research Consortium (ARC) definitions.
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT 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.
Trial Locations
- Locations (253)
Thomas Hospital
🇺🇸Fairhope, Alabama, United States
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Heart & Vascular Center of Arizona
🇺🇸Phoenix, Arizona, United States
Scottsdale Health Care
🇺🇸Scottsdale, Arizona, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
University of Arkansas (Central VA) for Medical Science
🇺🇸Little Rock, Arkansas, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
California Cardiovascular Consultants/ Washington Hospital
🇺🇸Fremont, California, United States
The Foundation for Cardiovascular Medicine
🇺🇸La Jolla, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Scroll for more (243 remaining)Thomas Hospital🇺🇸Fairhope, Alabama, United States