Conditions: Coronary Arteriosclerosis Acute Coronary Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 139
Healthy volunteers: no

Brief summary:
This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).

Detailed description:

Arms:
arm 1: Open label (lead-in) dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. arm 2: Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. arm 3: Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.

Interventions: intervention 1: prasugrel 10 mg intervention 2: clopidogrel intervention 3: prasugrel placebo intervention 4: prasugrel 60 mg intervention 5: clopidogrel placebo
Intervention descriptions: intervention 1: 10 mg tablet taken orally intervention 2: 75 mg tablet taken orally intervention 3: oral, as blinding mechanism. intervention 4: 60 mg (six 10-mg tablets) taken orally intervention 5: oral, as blinding mechanism

Protocol document: