Conditions: Cerebral Infarction Atherosclerosis
Keywords: Infarction, Cerebral cilostazol stenosis atherosclerosis clopidogrel
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 457
Healthy volunteers: no

Brief 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

Arms:
arm 1: cilostazol 100mg bid plus placebo of clopidogrel arm 2: clopidogrel 75mg qd and matching placebo of cilostazol

Interventions: intervention 1: clopidogrel intervention 2: Cilostazol
Intervention descriptions: intervention 1: Clopidogrel 75mg once a day plus placebo of cilostazol twice a day intervention 2: Cilostazol 100mg twice a day plus placebo of clopidogrel once a day

Protocol document: