To determine whether the administration of clopidogrel on top of ASA is superior to ASA alone in reducing the frequency of TCD-detectable MES in patients with recent symptomatic carotid stenosis.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Clopidogrel (Plavix®)Drug
Other Names: Plavix, Clodelib, Clovelen Intervention Desc: Antiplatelet agent
Multi-center, randomized, double-blinded study of a planned 100 patients.
Patients are randomized to receive either clopidogrel (300 mg loading dose on Day 1 followed by 75 mg/day thereafter) or placebo; all patients receive ASA 75 mg/day. The duration of treatment is 7 plus or minus 1 days.
|Type||Measure||Time Frame||Safety Issue|
|Primary||The primary endpoint is the percentage of MES-positive patients at Day 7 (plus or minus 1 day). Evaluation criteria for safety include the incidence of adverse events, cerebrovascular events, life-threatening and major bleeding and of all bleeding events.|
|Secondary||The percentage of MES-positive patients at 24 hours after study drug initiation; the rate of embolization (number of MES per hour) at 24 hours and at Day 7 plus or minus 1; and percentage change from baseline for platelet tests performed on platelet-rich plasma at Day 7 (plus or minus 1 day) (collagen-induced platelet aggregation, soluble P-selectin, prothrombin fragment F1+2 and D-dimers).|