NCT00664846已完成不适用
Standard Medical Management in Secondary Prevention of Ischemic Stroke in China.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,000
- 试验地点
- 46
- 主要终点
- Success Rate of standard medical management
研究概览
简要总结
The purposes of the study are to analyse the cross-section data of secondary stroke prevention in China and to carry out a standard medical management including medicine and interactive education program,and to evaluate the efficacy and safety of the standard medical management in secondary stroke prevention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic cerebral infarction or TIA within 30 days.
- •Aged above 18 years old.
- •Hospitalized.
- •Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
- •Stable clinical and neurological conditions.
- •A Modified Rankin score less than 4 at enrollment
- •Informed consent is obtained.
排除标准
- •Patients will be excluded from entry if any of the criteria listed below are met
- •Documented stroke caused by conditions other than atherosclerosis, ie, surgical or vascular intervention procedure.
- •Severe co-morbid or unstable medical condition, ie, heart failure, respiratory failure and renal failure, severe liver dysfunction, malignancy with likelihood of death within the next 2 years
- •Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
- •A Modified Rankin score is more than 4
- •Concurrent participation in another clinical trial
- •Unable to give informed consent.
研究组 & 干预措施
1
Experimental
干预措施: Aspirin / Clopidogrel, Atorvastatin / Simvastatin (Drug)
2
Active Comparator
干预措施: Asprin / Clopidogrel, Atorvastatin / Simvastatin (Drug)
结局指标
主要结局
Success Rate of standard medical management
时间窗: 1 year after enrolled
次要结局
- Ischemic stroke(1 year after enrolled)
- Non-fatal acute coronary syndrome(1 year after enrolled)
- Transient Ischemic Attack(1 year after enrolled)
- Hemorrhagic Stroke(1 year after enrolled)
- All-cause Death(1 year after enrolled)
研究者
研究点 (46)
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