Conditions: Atherosclerosis Myocardial Ischemia Myocardial Infarction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 120
Healthy volunteers: no

Brief summary:
The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population.

Detailed description:
The study drug (loading dose) is administered at least 1 hour before catheterization for diagnostic imaging or percutaneous coronary interventions (PCI). The incidence of bleeding is thought to be an important index to assess the safety of this drug, therefore thrombolysis in myocardial infarction (TIMI) is evaluated.

Arms:
arm 1: Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 2: Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 3: Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 4: Vorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 5: Placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine)

Interventions: intervention 1: Vorapaxar intervention 2: Placebo intervention 3: Aspirin intervention 4: Clopidogrel
Intervention descriptions: intervention 1: Oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days intervention 2: Oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days intervention 3: Loading dose of 75-325 mg on Day 1, then 75-100 mg once daily for 60 days. intervention 4: 100 mg two or three times daily for 60 days.

Protocol document: