The multi-center, double-blind, placebo-controlled, randomized, group-comparison study was designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in preventing the recurrence of cerebral infarction in patients who had suffered a cerebral infarction 1 to 6 months prior to entering the trial.
- Cilostazol (Pletal®)Drug
Other Names: pletal Intervention Desc: oral tablet 100 mg, twice daily, over 1 year ARM 1: Kind: Experimental Label: cilostazol Description: cilostazol oral tablet 100 mg, twice daily
- Placebo of cilostazol Drug
Intervention Desc: oral tablet, 0 mg twice daily, over 1 year ARM 1: Kind: Experimental Label: placebo Description: placebo of cilostazol, twice daily
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Oral administration of cilostazol (100 mg twice daily) or placebo was randomly assigned to the patients.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Recurrence of cerebral infarction.|
|Primary||Recurrence of cerebral infarction||any time||Yes|
|Secondary||Cerebral infarction or myocardial infarction, Cerebral infarction, intracranial hemorrhage, or TIA, Cerebral infarction, intracranial hemorrhage, myocardial infarction, or vascular death, All vascular events, vascular death, and Death from any cause||any time||Yes|