NCT00547950Unknown不适用
A Model Study on the Comprehensive Treating Protocol of Secondary Prevention and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine
Guangzhou University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2007年11月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- recurrence of stroke
研究概览
简要总结
In order to observe the influence of the Dengzhan Shengmai Capsule on the endpoint of patients with ischemic stroke, we hold the multi-centered prospective cohort study. From November 2007 to December 2009, 12000 subjects are included in 200 clinical research centers all over China. The subjects naturally formed two cohorts based on taking Dengzhan Shengmai capsule or not. The basic therapy included antiplatelet aggregation , stroke health education, management of blood pressure, blood lipid and blood glucose, etc. Then all of the subjects are visited on the 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-75 years old
- •Ischemic stroke diagnosed by CT/MRI scan
- •Patient presenting from 14 days to 6 months of first onset of Ischemic stroke.
- •Presence of at least one risk factor of stroke (such as hypertension, Diabetes mellitus, coronary heart disease, hyperlipidemia, and smoking, etc.)that can be interfered in.
- •Informed consent.
排除标准
- •Silent cerebral infarction;
- •Patients after vasculoplasty with Intracranial Artery Stenosis.
- •Watian drinking test≥grade
- •MRS=grade
- •Cerebral infarction due to other causes except arterial Sclerosis(i.e. cardiogenic embolism, arteritis, polycythemia vera, primary thrombocythemia, sickle-cell anemia,, thrombotic thrombocytopenia purpura, DIC, cerebral amyloid angiopathy, Moyamoya disease, intracranial vascular malformations etc);
- •Presence of serious heart disease, heart, liver, lung, and kidney functional failure; malignancy; alimentary tract hemorrhage;
- •Patients with mental disorder.
- •Patients that cannot take medicine due to other causes
- •Females during pregnancy or lactation.
- •Already attend other clinical trial.
- •That unsuitable for clinical trial.
结局指标
主要结局
recurrence of stroke
时间窗: 1 year
次要结局
- Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)(1 year)
研究者
研究点 (1)
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