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

Completed

Phase 4 Results

Trial Description

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).

Conditions

Interventions

  • Cilostazol (PletalĀ®)Drug
    Other Names: Claudiasil
    Intervention Desc: oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
    ARM 1: Kind: Experimental
    Label: 1
    Description: cilostazol
  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    Intervention Desc: oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
    ARM 1: Kind: Experimental
    Label: 2
    Description: Aspirin

Trial Design

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

Patient Involvement

Patients who suffered cerebral infarction within 26 weeks prior to enrollment and whosesymptoms were stable thereafter were randomly assigned to receive either cilostazol (100 mg twice daily) or aspirin (81mg, once daily). The study period is from December 2003 through December 2008, with individual patient treatmentand observation being between 1 and 5 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary Occurrence of cerebral stroke (cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage).
Secondary The secondary endpoints are recurrence of cerebral infarction, occurrence of ischemic cerebral disorder (cerebral infarction or transient ischemic attack), occurrence of all-cause death, and occurrence of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack, angina pectoris, myocardial infarction, cardiac failure, and hemorrhage requiring hospitalization.
Primary Numbers of Patients With First Occurence of Stroke From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months]) No
Secondary Number of Patients With First Recurrence of Cerebral Infarction From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) No
Secondary Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) No
Secondary Number of Deaths From Any Cause From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) No
Secondary Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) No

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