Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

Summary

The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).

Timeline

Start

2003-12

Primary completion

2008-12

Completion

2008-12

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Cilostazol vs Aspirin; p = 0.0357; Hazard Ratio, log 0.743 (95% CI 0.564 to 0.981); NCT00234065 ↗

Publications

• Results Shinohara Y, Katayama Y, Uchiyama S, Yamaguchi T, Handa S, Matsuoka K, Ohashi Y, Tanahashi N, Yamamoto H, Genka C, Kitagawa Y, Kusuoka H, Nishimaru K, Tsushima M, Koretsune Y, Sawada T, Hamada C; CSPS 2 group. Cilostazol for prevention of secondary stroke (CSPS 2): an aspirin-controlled, double-blind, randomised non-inferiority trial. Lancet Neurol. 2010 Oct;9(10):959-68. doi: 10.1016/S1474-4422(10)70198-8. Epub 2010 Sep 15.

Drugs

Indications