Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
- Conditions
- Embolic Stroke
- Interventions
- Drug: Placebo Injection
- Registration Number
- NCT03090113
- Lead Sponsor
- Beijing Tiantan Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2416
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Injection Placebo Injection Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10; Shuxuetong Injection Shuxuetong Injection Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
- Primary Outcome Measures
Name Time Method Symptomatic or Asymptomatic New Cerebral Infarction 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 Outcome Measures
Name Time Method Symptomatic Cerebral Infarction 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.
Asymptomatic Cerebral Infarction 10 days Those patients who are still alive at 10 days after randomization will be contacted to set up a follow-up clinical visit. MRI examination including diffusion weighted imaging (DWI) sequence will be performed.
NIHSS Score Increase 10 days Those patients who are still alive at hospital discharge will be contacted to set up a follow-up clinical visit. Neurological and functional assessments including NIHSS will be performed.
Combined Vascular Events 90 days Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death.
Cerebral Infarction Volume Expansion 10 days Those patients who are still alive at hospital discharge will be contacted to set up a follow-up clinical visit. MRI examination will be performed.
Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage) 90 days Those patients who are still alive at 90days after onset will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent symptomatic stroke will be collected.
Recurrent Symptomatic Ischemic Stroke 90 days Those patients who are still alive at 90days after onset will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent symptomatic ischmemic stroke will be collected.
Disability or Death 90 days Disability or Death was defined as a score of 3 to 6 on the modified Rankin Scale at 90days after onset.
Trial Locations
- Locations (48)
Wuhu No.1 People's Hospital
🇨🇳Wuhu, Anhui, China
Beijing Tian Tan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Ansteel Group Hospital
🇨🇳Beijing, Beijing, China
Beiujing Fengtai Youanmen Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Fangshan District
🇨🇳Beijing, Beijing, China
Yongchuan hospital of Traditional Chinese Medicine
🇨🇳Chongqing, Chongqing, China
Houjie Hospital
🇨🇳Dongguan, Guangzhou, China
Cangzhou Peoole's Hospital
🇨🇳Cangzhou, Hebei, China
People's Hospital of Hejian
🇨🇳Cangzhou, Hebei, China
Kuancheng County Hospital
🇨🇳Chengde, Hebei, China
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