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).
\[Goal\] 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
457
Clopidogrel 75mg once a day plus placebo of cilostazol twice a day
Cilostazol 100mg twice a day plus placebo of clopidogrel once a day
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Number of Participants With Progression of Symptomatic Intracranial Stenosis
Blind reviewers classified the presence and severity of stenosis on middle cerebral arteries and basilar artery on magnetic resonance angiogram (MRA) into 5 grades; normal, mild, moderate, severe and occlusion. Progression was defined as worsening of stenosis by 1 or more grades on final MRA as compared with the baseline MRA. The progression of symptomatic stenosis is defined as 1 or more grade worsening of the stenosis on the symptomatic artery on MRA.
Time frame: 7 months after treatment
Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI
number of patients with new ischemic lesions on FLAIR (Fluid attenuation inversion recovery) images of follow-up MRI, which were determined by slice to slice comparison with baseline MRI.
Time frame: 7 months after treatment
Number of Participants With Stroke Events
including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke
Time frame: upto 7 months after randomization
Number of Participants With Overall Cardiovascular Events
including nonfatal stroke, nonfatal myocardial infarction and vascular death.
Time frame: upto 7 months after randomization
Number of Patients With Ipsilateral Ischemic Stroke Rate
ischemic stroke event which occured in the vascular territory of initial symptomatic stenosis
Time frame: upto 7 months after randomization
Numbers of Fatal or Major Bleeding Complications
life-threatening or fatal bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood
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Philippine General Hospital
Manila, Philippines
University of Santo Tomas Hospital
Manila, Philippines
Konkuk Univ. Hospital
Seoul, Gwangjin-gu Hwayang-dong, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Dongguk University International Hospital
Goyang, Kyoungki-do, South Korea
Hallym University Sacred Heart Hospital
Anyang, Kyunggi, South Korea
Soonchunhyang University Hospital
Seoul, Seoul, South Korea
Inha University Hospital
Inchon, South Korea
...and 9 more locations
Time frame: upto 7 months after randomization