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 studyοΌEvaluate 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)
Wu Yuan People's Hospital
π¨π³Bayan Nur, Neimenggu, China
The Affiliated Hospital of Qingdao University
π¨π³Qingdao, Shandong, China
Wuhu No.1 People's Hospital
π¨π³Wuhu, Anhui, China
The First Hospital of Fangshan District
π¨π³Beijing, Beijing, China
Yongchuan hospital of Traditional Chinese Medicine
π¨π³Chongqing, Chongqing, China
Ansteel Group Hospital
π¨π³Beijing, Beijing, China
Beiujing Fengtai Youanmen Hospital
π¨π³Beijing, Beijing, China
Cangzhou Peoole's Hospital
π¨π³Cangzhou, Hebei, China
The Second Hospital of Hebei Medical University
π¨π³Shijiazhuang, Hebei, China
Heilongjiang Province Agricultural Reclamation Mudanjiang Authority Central Hospital
π¨π³Mudanjiang, Heilongjiang, China
People's Hospital of Hejian
π¨π³Cangzhou, Hebei, China
Kuancheng County Hospital
π¨π³Chengde, Hebei, China
Traditional Chinese Medicine Hospital of Qiu County
π¨π³Handan, Hebei, China
Jiangsu Province Hospital of TCM
π¨π³Nanjing, Jiangsu, China
Zhangjiagang First People's Hospital
π¨π³Suzhou, Jiangsu, China
The First Hospital of Jilin University-the Eastern Division
π¨π³Changchun, Jilin, China
The First Affiliated Hospital of Baotou Medical College
π¨π³Baotou, Neimenggu, China
Jinzhou Medical University
π¨π³Jinzhou, Liaoning, China
Huimin People's Hospital
π¨π³Binzhou, Shandong, China
Affiliated Hospital of Chifeng University
π¨π³Chifeng, Neimenggu, China
Qingdao Haci medical group hospital
π¨π³Qingdao, Shandong, China
Dongyang People's Hopital
π¨π³Dongyang, Zhejiang, China
Lishui People's Hospital
π¨π³Lishui, Zhejiang, China
The Second People's Hospital of Shenzhen
π¨π³Shenzhen, Shenzhen, China
No.1 People's Hospital of Taizhou
π¨π³Taizhou, Zhejiang, China
Hengshui Fourth Hospital
π¨π³Hengshui, Hebei, China
Beijing Tian Tan Hospital, Capital Medical University
π¨π³Beijing, Beijing, China
Houjie Hospital
π¨π³Dongguan, Guangzhou, China
Jizhou District Hospital of Hengshui
π¨π³Hengshui, Hebei, China
Handan Municipal Center Hospital
π¨π³Handan, Henan, China
The First Affiliated Hospital of University of South China
π¨π³Hengyang, Henan, China
People's Hospital of Zhongmu
π¨π³Zhengzhou, Henan, China
Shijiazhuang Pingan Hospital Affiliated to Hebei Medical University
π¨π³Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Jiamusi University
π¨π³Jiamusi, Heilongjiang, China
Nantong 3rd People's Hospital
π¨π³Nantong, Jiangsu, China
Zhengzhou Yihe Hospital Affiliated to Henan University
π¨π³Zhengzhou, Henan, China
Jingmen City Hospital of Traditional Chinese Medicine
π¨π³Jingmen, Hubei, China
Zhangjiagang Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine
π¨π³Suzhou, Jiangsu, China
Wuhan NO.1 Hospital,Wuhan Hospital Of Traditional Chinese And Western Medicine
π¨π³Wuhan, Hubei, China
Jiangxi Provincial People's Hospital
π¨π³Nanchang, Jiangxi, China
The Affiliated Hospital of Xuzhou Medical College
π¨π³Xuzhou, Jiangsu, China
The Second People's Hospital of Huludao
π¨π³Huludao, Liaoning, China
People's Hospital of Penglai
π¨π³Penglai, Shandong, China
Shandong Provincial Western Hospital
π¨π³Jinan, Shandong, China
Ningjin County People's Hospital
π¨π³Dezhou, Shandong, China
People's Hospital of Qingdao West Coast New Area
π¨π³Qingdao, Shandong, China
Ruian People's Hospital
π¨π³Wenzhou, Zhejiang, China
First Hospital of Shanxi Medical University
π¨π³Taiyuan, Shanxi, China