Cilostazol Stroke Prevention Study : A Placebo-Controlled Double-Blind Trial for Secondary Prevention of Cerebral Infarction. "CSPS"

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Cilostazol (PletalĀ®)Drug
    Other Names: Claudiasil
    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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Oral administration of cilostazol (100 mg twice daily) or placebo was randomly assigned to the patients.

Outcomes

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

Sponsors