Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

Completed

Phase 4 Results N/A

Trial Description

The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.

Detailed Description

Stroke is a leading cause of death and elderly disability in developed countries. However, treatment of acute stroke is limited except thrombolytic therapy in hyperacute stroke within several hours. Currently, aspirin is widely used in spite of its small benefit compared to bleeding complications.
Cilostazol will be compared to aspirin in acute stroke patients in terms of functional outcome at 3 months, efficacy to prevent stroke recurrence, and safety for bleeding complications.

Conditions

Interventions

  • Aspirin (acute stroke) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Cilostazol (PletalĀ®)Drug
    Other Names: Claudiasil
  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole

Trial Design

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

Patient Involvement

Cilostazol 200mg/day or aspirin 300mg/day is given for 90 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Comparison of the frequency of mRS 0, 1, 2 at 90 days.
Secondary Frequency of mRS 0,1 at 90 days; frequency of Barthel index 95-100 at 90 days; frequency of mRS 0,1 & Barthel index 95-100 at 90 days; frequency of NIHSS 0-1 at 90 days; frequency of progression of neurological deficit at 7 days; bleeding disorders; overall cardiovascular events (Ischemic heart disease requiring rehospitalization).
Primary Comparison of the frequency of mRS 0, 1, 2 at 90 days at 90 days
Secondary Frequency of mRS 0,1 at 90 days at 90 days
Secondary Frequency of Barthel index 95-100 at 90 days
Secondary Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
Secondary Frequency of NIHSS 0-1 at 90 days
Secondary Frequency of progression of neurological deficit at 7 days (increment of NIHSS 2 points or a point on the item of upper or lower extremity weakness)
Secondary Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding)
Secondary Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)

Sponsors