Abstract T P334: Clopidogrel and Aspirin versus Aspirin Alone for Prevention of Recurrent Ischemic Lesion in Acute Atherothrombotic Stroke: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Background: Combination treatment with clopidogrel and aspirin is not currently recommended for secondary prevention of stroke, but its superior effect to aspirin alone has been controversial according to stroke subtype and stage. We sought to compare the effect of aspirin and clopidogrel to aspirin alone for recurrent ischemic lesion in acute stage of atherothrombotic stroke. Methods: Combination of clopidogrel and aspirin for prevention of recurrence in acute atherothrombotic stroke study (COMPRESS) was a prospective, randomized, double-blind, placebo-controlled, multicenter trial. We enrolled 358 patients with acute atherothrombotic stroke within 48 hours after symptom onset, and randomly assigned them to receive clopidogrel (75 mg per day) plus aspirin (100 mg per day) or aspirin alone (100 mg per day) for 30 days. The primary endpoint was proportion of patients with a newly developed ischemic lesion within 30 days, as confirmed with brain MRI. Secondary endpoints were modified Rankin Scale scores at 30 days, occurrence of the composite endpoint of non-fatal stroke, myocardial infarction and cardiovascular death, and incidence of all types of stroke. The clinicaltrials.gov registration number for this trial was NCT00814268. Results: Among 358 patients enrolled, 349 patients who received at least one dose of study medication after randomization were included in the efficacy analysis population (clopidogrel plus aspirin, n=174; aspirin alone, n=175).Recurrent ischemic lesions were observed in 61 patients in the combination group (36.5%) and 60 patients in the aspirin alone group (35.9%; p=0.91). The significant difference was not found between the groups in the secondary endpoints. In the safety analysis, any bleeding incidence was non-significantly higher in the combination group (n=29 vs. n=19; p=0.10), and episodes of life-threatening hemorrhage and major hemorrhage were very low in both groups. Conclusion: Combination treatment of clopidogrel and aspirin is not superior to aspirin alone for prevention of recurrent ischemic lesion in acute atherothrombotic stroke patients. Acknowledgement: This study was co-sponsored by Sanofi-Aventis Korea and BMS Korea.