Cilostazol, an
antiplatelet drug that increases the cyclic
adenosine monophosphate (
AMP) levels in platelets via inhibition of
cyclic AMP phosphodiesterase, has been used in chronic
arterial occlusive disease. The purpose of the present study was to examine the effects of
cilostazol on the recurrence of
cerebral infarction using a multicenter, randomized, placebo-controlled, double-blind clinical trial method. Patients who suffered from
cerebral infarction at 1 to 6 months before the trial were enrolled between April 1992 and March 1996.
Oral administration of
cilostazol (100 mg twice daily) or placebo was randomly assigned to the patients and continued until February 1997. The primary endpoint was the recurrence of
cerebral infarction. In total, 1,095 patients were enrolled. An analysis based on 1,052 eligible patients (526 given
cilostazol and 526 given placebo) showed that the
cilostazol treatment achieved a significant relative-risk reduction (41.7%; confidence interval [CI], 9.2% to 62.5%) in the recurrence of
cerebral infarction as compared with the placebo treatment (P=.0150). Intention-to-treat analysis of 1,067 patients also showed a significant relative-risk reduction (42.3%; CI, 10.3% to 62.9%, P=.0127). No clinically significant
adverse drug reactions of
cilostazol were encountered. Long-term administration of
cilostazol was effective and safe in the
secondary prevention of
cerebral infarction.