The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.
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.
- Aspirin (acute stroke) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Cilostazol (Pletal®)Drug
Other Names: Claudiasil
- Aspirin Drug
Other Names: clopidogrel; combination aspirin-dipyridamole
- Allocation: Randomized
- Masking: Double-Blind
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Cilostazol 200mg/day or aspirin 300mg/day is given for 90 days.
|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)|