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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.
Details
| Lead sponsor | Baim Institute for Clinical Research |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 25682 |
| Start date | 2009-10 |
| Completion | 2014-06 |
Conditions
- Coronary Artery Disease
Interventions
- Placebo & Aspirin
- Clopidogrel & Aspirin, Prasugrel & Aspirin
Primary outcomes
- 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.
Countries
United States, Australia, Czechia, France, Germany, Hungary, New Zealand, Poland, Romania, United Kingdom