NCT00130039

Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II

Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (MCA) or basilar artery). They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally. The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on magnetic resonance angiogram (MRA).

Detailed description

\[Goal\] To Reveal the Effect and Safety of Cilostazol Compared with Clopidogrel on the Prevention of the Progression of Symptomatic Intracranial Arterial Stenosis. \[Trial Design\] Double-Blind, Active-Controlled, Randomized, Multicenter Trial \[Participants\] Acute ischemic stroke patients with symptomatic intracranial arterial stenosis \[Methods\] * Double-Blind, Active-Controlled, Randomized, Multicenter Trial * Investigational product (Double Dummy Method): Cilostazol 200mg (100mg twice per day) versus clopidogrel 75mg * Concomitant medication: Aspirin 100 (75-150) mg per day * Medication Duration: 7 months \[Outcome Variables\] Primary Outcome Variable: * Progression rate of symptomatic intracranial arterial stenosis Secondary outcome variables: * The occurrence of new MRI (magnetic resonance image) lesion on follow-up MRI * Stroke events * Overall cardiovascular events: stroke, acute coronary syndrome, vascular death * Ipsilateral ischemic stroke rate * Fatal or major bleeding complications

Conditions

• Cerebral Infarction
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	clopidogrel	Clopidogrel 75mg once a day plus placebo of cilostazol twice a day
DRUG	Cilostazol	Cilostazol 100mg twice a day plus placebo of clopidogrel once a day

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2005-08-15
• Last updated: 2010-01-12
• Results posted: 2010-01-01

Locations

19 sites across 4 countries: Hong Kong, Philippines, South Korea, Thailand