Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

Cerebral Infarction Clinical Trial

Official title: Cilostazol Stroke Prevention Study-a Randomized, Double Blind, Double Dummy, Parallel Comparative, Multicenter Clinical Trial

Status Completed

Clinical Trial Summary

The study design is subject to relevant SFDA regulations about clinical trials. This indication was approved in Japan in 2003.

From the end of May 2004 to the end of Dec. 2004, 720 patients with previous cerebral infarction(see the inclusion criteria) were enrolled in to the study and received one of the two treatment regimens, Cilostazol or Aspirin, the ratio of patient number of each group is 1:1. For each patient, the chance of entering either of these two groups is the same. The treatment will continue till the end of 2005. During the treatment period, patients will be observed concerning some certain events, mainly reoccurrence of stroke. If the patient experiences reoccurrence of stroke, or other event that the doctors think it is not appropriate to continue the study medication, this patient would stop the treatment. Patients were also required to take MRI head scan before entering the study and on completion of the treatment.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

• NCT number: NCT00202020
• Study type: Interventional
• Source: Otsuka Beijing Research Institute
• Status: Completed
• Phase: Phase 3
• Start date: May 2004
• Completion date: January 2006