A Prospective Randomized Control Double-blinded Phase Ⅲ Clinical Study Of Cilostazol In Prevention Of Recurrence Of Cerebral Infarction

BACKGROUND & OBJECTIVE Cilostazol, a phosphodiesterase type â…¢ inhibitor, plays a role in inhibition of platelet aggregation, thrombosis and so on. The current study was to evaluate the efficacy and safety of cilostazol in secondary prevention of cerebral infarction.Method A prospective, randomized, control, double-blinded, phase â…¢ clinical study was conducted. 50 patients with a history of cerebral infarction (excluding cardiogenic cerebral infarction) were randomized to receive cilostazol 200mg per day or aspirin 100mg per day for 12 months. There were 24 patients in cilostazol group, and 26 patients in aspirin group. The efficacy and safety were recorded per month. Results Among 39 valuable cases, the efficacy was similar between the two groups. The main adverse invents of cilostazol group were diarrhea, headache, dizziness and abnormality of electrocardiogram. Most of them were considered to have a relationship with cilostazol. Among these adverse invents, diarrhea and abnormality of electrocardiogram were significantly higher in cilostazol group ( P<0.05 ), but mostof they were not serious, and they would remit or vanish by cilostazol extenuation,short-term withdrawal, even without any treatment. Only a few of them gave upbecause of these adverse invents. The incidence rate of serious adverse events andhemorrhagic adverse events ( excluding cerebral hemorrhage and subarachnoidhemorrhage) was significantly higher in aspirin group (P<0.05) . Although the seriousadverse events were considered to have nothing to do with aspirin, it seemed that thesafety of cilostazol was better than aspirin.Conclusion Cilostazol is as effective as aspirin in secondary prevention of cerebralinfarction, and it has a good safety.