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


Phase 4 Results

Summary of Purpose

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).

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 9 June 2011.

1 Dec 2003 4 Oct 2005 1 Dec 2008 1 Dec 2008 1 Jun 2011 19 Apr 2011
Start Date First Received 1st Completion Completion Verification Results

Trial Basics




Trial Design

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


  • Katsuhisa Saito Division of New Product Evaluation and Development