A Random, Double-blind, Parallel, Placebo-controlled, Multi-center Study of Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,416
- 试验地点
- 48
- 主要终点
- Symptomatic or Asymptomatic New Cerebral Infarction
研究概览
简要总结
This is a randomized, double blind, placebo-controlled, parallel, multicenter research in order to evaluate the effect of Shuxuetong injection in prevention of symptomatic or asymptomatic new cerebral infarction within 10 days.
Subgroup study：Evaluate the role of advanced diagnostic technique in identifying potential causes of Embolic Stroke of Undetermined Source (ESUS).
详细描述
Shuxuetong injection or Placebo injection for 10days. About 2416 patients randomized at 80 centers all over China with 20 subgroup study centers.
Face to face interview at baseline, 10 days, and 90 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Shuxuetong Injection
Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
干预措施: Shuxuetong Injection (Drug)
Placebo Injection
Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;
干预措施: Placebo Injection (Drug)
结局指标
主要结局
Symptomatic or Asymptomatic New Cerebral Infarction
时间窗: 10 days
Those patients who are still alive at 10 days after randomization will be contacted to set up a follow-up clinical visit. Information of recurrent symptomatic cerebral infarction will be collected and MRI examination will be performed to detect asymptomatic new cerebral infarction.
次要结局
- Symptomatic Cerebral Infarction(10 days)
- Disability or Death(90 days)
- Asymptomatic Cerebral Infarction(10 days)
- NIHSS Score Increase(10 days)
- Combined Vascular Events(90 days)
- Cerebral Infarction Volume Expansion(10 days)
- Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage)(90 days)
- Recurrent Symptomatic Ischemic Stroke(90 days)
研究者
Yongjun Wang
Executive Vice-President
Beijing Tiantan Hospital