NCT00814268已完成4 期
COMbination of Clopidogrel and Aspirin for Prevention of REcurrence in Acute Atherothrombotic Stroke Study: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke
研究概览
简要总结
Primary objective:
- Comparison of efficacy of the combination therapy (clopidogrel plus aspirin) and the aspirin alone (main comparison) to prevent any recurrent ischemic lesion .
Secondary objectives:
- Comparison of Modified Rankin scale (mRS) scores;
- Comparison of the Incidence of all kinds of stroke and vascular death;
- Comparison of the Incidence of bleeding episodes (major and minor) and symptomatic intracerebral hemorrhages during the follow-up period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke diagnosed within 48 hours from symptom onset;
- •Cerebral ischemic lesion observed on diffusion-weighted magnetic resonance imaging (DWI MRI);
- •Relevant atherothrombotic lesions on magnetic resonance angiography (MRA) or computed tomography angiography (CTA);
- •Study drug administration within 48 hours from symptom onset;
- •mRS score is 0-2 before the stroke.
排除标准
- •Evidences of other relevant brain lesions such as Intracerebral hemorrhage (ICH) or brain tumor;
- •Suspicious of stroke due to small-vessel occlusion;
- •Stroke due to cardioembolism;
- •Clinical necessity of conventional angiography or intervention before the end of study;
- •Past history of ICH;
- •Bleeding diathesis or coagulopathy;
- •Chronic anemia (Hb<8.0) or thrombocytopenia (PLT<100K);
- •Chronic liver disease (AST> 100 or ALT>100);
- •Any other clinically relevant serious disease, including renal failure ( creatinine clearance<30mL/min);
- •Allergy to Aspirin or clopidogrel;
- •Subjected to intervention or surgical treatments within 3 months;
- •Thrombolysis performed with rt-PA or UK after the stroke;
- •Participation in another clinical study within the previous 30 days;
- •Suspicious of poor drug compliance and requirements of the protocol;
- •Females who are pregnant, breast-feeding, or childbearing potential and not using medically acceptable and effective contraception.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Combination therapy
Experimental
Administration of Aspirin + Clopidogrel for 30 days
干预措施: Clopidogrel (Drug)
Combination therapy
Experimental
Administration of Aspirin + Clopidogrel for 30 days
干预措施: Aspirin (Drug)
Monotherapy
Active Comparator
Administration of Aspirin + Clopidogrel placebo for 30 days
干预措施: Clopidogrel placebo (Drug)
Monotherapy
Active Comparator
Administration of Aspirin + Clopidogrel placebo for 30 days
干预措施: Aspirin (Drug)
结局指标
主要结局
Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke
时间窗: Within 30 days following the onset of acute atherothrombotic stroke
次要结局
- Distribution of Modified Rankin Scale (mRS) scores(Day 30 after the onset of acute atherothrombotic stroke)
- Number of participants with non-fatal stroke, myocardial infarction (MI) or cardiovascular death (composite endpoint, first-ever)(Within 30 days following the onset of acute atherothrombotic stroke)
- Number of participants with stroke (all kinds)(Within 30 days following the onset of acute atherothrombotic stroke)
- Number of participants with bleeding episode (major or minor)(Within 30 days following the onset of acute atherothrombotic stroke)
- Number of participants with symptomatic intracerebral hemorrhage (ICH)(Within 30 days following the onset of acute atherothrombotic stroke)
研究者
研究点 (1)
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