A Random, Double-blind, Parallel, Placebo-controlled, Multi-center Study of Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
Overview
- Phase
- Phase 4
- Intervention
- Shuxuetong Injection
- Conditions
- Embolic Stroke
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 2416
- Locations
- 48
- Primary Endpoint
- Symptomatic or Asymptomatic New Cerebral Infarction
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Yongjun Wang
Executive Vice-President
Beijing Tiantan Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Shuxuetong Injection
Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
Intervention: Shuxuetong Injection
Placebo Injection
Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;
Intervention: Placebo Injection
Outcomes
Primary Outcomes
Symptomatic or Asymptomatic New Cerebral Infarction
Time Frame: 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.
Secondary Outcomes
- 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)