Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients received one of the two treatment regimens, Cilostazol 100 mg twice a day or Aspirin 100 mg. once a day, the ratio of patient number of each group is 1:1. During the treatment period, patients will be observed for 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage).
Secondary Recurrence of cerebral infarction detected in MRI; death due to cerebral vascular events; myocardial infarction; vascular events(acute artery thrombosis/embolism, pneumonia embolism, venous thrombosis, angina pectoris); TIA; death.
Primary Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)
Secondary Recurrence of cerebral infarction detected in MRI
Secondary Death due to cerebral vascular events
Secondary Myocardial infarction
Secondary Vascular events(acute artery thrombosis/embolism, pneumonia embolism, venous thrombosis, angina pectoris)
Secondary TIA
Secondary Death

Sponsors