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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 25,682
- Locations
- 253
- Primary Endpoint
- MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Placebo & Aspirin (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.
Intervention: Clopidogrel & Aspirin, Prasugrel & Aspirin (Drug)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- 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))
- MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS(33 months (0-33 months post-index procedure))
- Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS(33 months (0-33 months post-index procedure))
- GUSTO Severe or Moderate Bleeding - Randomized DES ITT(21 months (12-33 months post-index procedure))
- 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))
- GUSTO Severe or Moderate Bleeding - Randomized BMS ITT(21 months (12-33 months post-index procedure))