Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 19
- 主要终点
- Number of Participants With Progression of Symptomatic Intracranial Stenosis
研究概览
简要总结
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).
详细描述
[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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral infarction within 2 weeks from the onset or TIA with corresponding acute ischemic brain lesions on MRI within 2 weeks from the onset
- •Age: more than 35 years of age
- •Patient with significant focal stenosis in the M1 segment of middle cerebral artery (MCA) or basilar artery (BA) with acute ischemic lesions on magnetic resonance imaging (MRI) within the vascular territory of the stenosed artery.
排除标准
- •Patients with any contraindications to the treatment with antiplatelet therapy
- •Patients with potential cardiac embolic source; prosthetic valve, atrial fibrillation, atrial flutter, left atrial/atrial appendage thrombus, sick sinus syndrome, left ventricular thrombus, dilated cardiomyopathy, akinetic or hypokinetic left ventricular segment, atrial myxoma, Infective endocarditis, mitral valve stenosis or prolapse, mitral annuls calcification, left atrial turbulence, nonbacterial endocarditis, congestive heart failure, recent myocardial infarction (within 4 weeks)
- •Patients with more than 50% stenosis in the parent artery of symptomatic stenosis
- •Bleeding diathesis
- •Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
- •Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
- •Nonatherosclerotic vasculopathy; patients with clinical characteristics suggesting arterial dissection, moyamoya disease, Takayasu's arteritis, radiation associated angiopathy, and other vasculitis.
- •Severe stroke: NIH stroke scale : more than 16
- •Pregnant or lactating patients
- •Chronic user of NSAIDs
- •Thrombolytic therapy for the symptomatic stenosis
- •Symptomatic stenosis scheduled for angioplasty
- •Patients with pacemaker or any other contraindications to MRI
研究组 & 干预措施
cilostazol
cilostazol 100mg bid plus placebo of clopidogrel
干预措施: Cilostazol (Drug)
Clopidogrel
clopidogrel 75mg qd and matching placebo of cilostazol
干预措施: clopidogrel (Drug)
结局指标
主要结局
Number of Participants With Progression of Symptomatic Intracranial Stenosis
时间窗: 7 months after treatment
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.
次要结局
- Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI(7 months after treatment)
- Number of Participants With Stroke Events(upto 7 months after randomization)
- Number of Participants With Overall Cardiovascular Events(upto 7 months after randomization)
- Number of Patients With Ipsilateral Ischemic Stroke Rate(upto 7 months after randomization)
- Numbers of Fatal or Major Bleeding Complications(upto 7 months after randomization)