NCT00386191已完成4 期
Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,110
- 试验地点
- 1
- 主要终点
- Incidence of bleeding adverse events
研究概览
简要总结
The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented
- •Patients with a cerebral infarct confirmed by Computed Tomography or Magnetic Resonance Image
- •Body weight : > 50 kg
排除标准
- •Patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement)
- •Patients with Transient Ischemic Attack occuring after the last episode of cerebral infarction
- •Patients with serious impairment that would hinder detection of new ischemic event
- •Patients with bleeding diathesis, coagulopathy, or hemorrhagic disease
- •Patients with history of intracranial hemorrhage
- •Patients with diabetic retinopathy
- •Hypertensive patients with a persistent increase of blood pressure.
研究组 & 干预措施
1
Experimental
50 mg
干预措施: clopidogrel (SR25990C) (Drug)
2
Experimental
75 mg
干预措施: clopidogrel (SR25990C) (Drug)
结局指标
主要结局
Incidence of bleeding adverse events
时间窗: study period
次要结局
- Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events.(study period)
研究者
研究点 (1)
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