A randomized, double-blind study comparing the safety and efficacy of clopidogrel versus ticlopidine in Japanese patients with noncardioembolic cerebral infarction

Background: Patients treated with ticlopidine require careful hematologic monitoring. Clopidogrel may have greater tolerability. However, no direct comparison of these two drugs has been reported and evidence of improved safety with clopidogrel is not yet established in the Japanese population. A comparison of both agents was therefore conducted in Japanese stroke patients. Methods: Patients with noncardioembolic cerebral infarction were randomized to clopidogrel 75 mg or ticlopidine 200 mg once daily for 52 weeks. The primary endpoint was safety; the major secondary endpoint was the incidence of vascular events. Results: Clopidogrel was associated with significantly fewer safety events than ticlopidine (7.0 versus 15.1%; p < 0.001) and no significant difference in efficacy between the two treatments was seen [hazard ratio 0.977 (95% confidence interval: 0.488-1.957)]. Conclusions: In Japanese stroke patients, clopidogrel 75 mg is better tolerated than ticlopidine 200 mg once daily. Copyright c 2007 S. Karger AG, Basel.