Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis "CARESS"

Completed

Phase N/A Results

Trial Description

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.

Interventions

Trial Design

Multi-center, randomized, double-blinded study of a planned 100 patients.

Patient Involvement

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.

Outcomes

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).

Sponsors

Sanofi-Aventis, Bristol Myers Squibb