Conditions: Coronary Artery Disease
Keywords: Heart Disease Cardiovascular Disease Platelet Aggregation Inhibitors Dual Antiplatelet Therapy Clopidogrel Prasugrel Vascular Disease Myocardial Ischemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2272
Healthy volunteers: no

Brief summary:
EDUCATE is a prospective, multi-center study designed to collect real-world safety and clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet therapy (DAPT) drug regimen.

Detailed description:
To provide clinical information on rates of late and very late stent thrombosis after Endeavor Drug-eluting Stent (DES)placement in an all comers population with a broad range of bleeding and thrombosis risk. EDUCATE will further analyze the current practice of clinicians regarding temporary cessation of antiplatelet therapy and its association with clinical outcomes. In addition, patients included in this broad Endeavor registry will also be contributed to the DAPT native study population for analysis of 12 vs 30 months duration of dual antiplatelet therapy.

Arms:
arm 1: Subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization. arm 2: Subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization. arm 3: Non randomized subjects followed through 24 months

Interventions: intervention 1: Placebo Arm intervention 2: Thienopyridine Therapy intervention 3: Surveillance Arm
Intervention descriptions: intervention 1: Placebo and ASA (75 mg - 325 mg) intervention 2: Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg) intervention 3: Non randomized arm to understand clinical outcomes in a commercial setting

Protocol document: