Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
NCT ID: NCT03090113
Last Updated: 2020-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2416 participants
INTERVENTIONAL
2017-05-12
2019-06-21
Brief Summary
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Subgroup study：Evaluate the role of advanced diagnostic technique in identifying potential causes of Embolic Stroke of Undetermined Source (ESUS).
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Detailed Description
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Face to face interview at baseline, 10 days, and 90 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Shuxuetong Injection
Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
Shuxuetong Injection
intravenous drip
Placebo Injection
Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;
Placebo Injection
intravenous drip
Interventions
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Shuxuetong Injection
intravenous drip
Placebo Injection
intravenous drip
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Acute ischemic stroke, brain magnetic resonance imaging showed non lacunar infarction (subcortical infarction less than or equal to 1.5 cm);
3. Onset within 72 hours;
4. Patients or their family members are willing to sign the informed consent.
Exclusion Criteria
2. Transient ischemic attack;
3. Lacunar infarction;
4. History of acute stroke within 6 months;
5. Clear diagnosis of other causes of ischemic stroke (arterial dissection, arteritis, vasospasm, etc.);
6. The acute infarcts lesion more than one-half lobe in size;
7. Preceding modified Rankin Scale (mRS) score ≥ 2;
8. Cumulative usage of traditional Chinese medicine which activating blood circulation more than 3 times after onset, including but not limited to: Danhong, Xueshuantong, Xuesaitong, Ginkgo biloba, sodium ozagrel, Salvia miltiorrhiza, ligustrazine, Erigeron breviscapus, etc;
9. Chronic liver disease, liver and kidney dysfunction, lifted alanine aminotransferase (\>3 times the ULN), lifted serum creatinine (\>2 times the ULN）;
10. History of coagulopathy, systemic bleeding, thrombocytopenia or neutropenia;
11. Blood pressure \>90/60 mmHg or ≤220/120 mmHg after treatment;
12. Serious heart or lung disease, in the judgment of clinical study staff, would not suitable to participant in the trial;
13. Patients with atrial fibrillation who were scheduled or likely to receive anticoagulant therapy with unfractionated heparin or low molecular weight heparin within 2 weeks after randomization
14. A medical condition likely to limit survival to less than three months or any other condition judged by the clinic team to likely limit the adherence to study procedures;
15. Known allergies for ingredients of the drug, allergy history for food or drug;
16. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;
17. Participation in another clinical trial within 30 days;
18. Unable to understand and/or comply with the study procedures and/or follow-up studies due to mental illness, cognitive or emotional disorders.
1. History of atrial fibrillation
2. Atrial fibrillation in 12-lead electrocardiogram (ECG);
3. Heart rate monitoring (dynamic electrocardiogram telemetry) up to 20 hours or more detected atrial fibrillation for 6 minutes or more;
4. Intracardiac thrombosis in thoracic or esophageal echocardiography;
5. Occlusion or proximal vessel infarction for more than 50%.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Yongjun Wang
Executive Vice-President
Principal Investigators
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Wang yongjun, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Locations
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Wuhu No.1 People's Hospital
Wuhu, Anhui, China
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Ansteel Group Hospital
Beijing, Beijing Municipality, China
Beiujing Fengtai Youanmen Hospital
Beijing, Beijing Municipality, China
The First Hospital of Fangshan District
Beijing, Beijing Municipality, China
Yongchuan hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, 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
Traditional Chinese Medicine Hospital of Qiu County
Handan, Hebei, China
Hengshui Fourth Hospital
Hengshui, Hebei, China
Jizhou District Hospital of Hengshui
Hengshui, Hebei, China
Shijiazhuang Pingan Hospital Affiliated to Hebei Medical University
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, China
Heilongjiang Province Agricultural Reclamation Mudanjiang Authority Central Hospital
Mudanjiang, Heilongjiang, China
Handan Municipal Center Hospital
Handan, Henan, China
The First Affiliated Hospital of University of South China
Hengyang, Henan, China
People's Hospital of Zhongmu
Zhengzhou, Henan, China
Zhengzhou Yihe Hospital Affiliated to Henan University
Zhengzhou, Henan, China
Jingmen City Hospital of Traditional Chinese Medicine
Jingmen, Hubei, China
Wuhan NO.1 Hospital,Wuhan Hospital Of Traditional Chinese And Western Medicine
Wuhan, Hubei, China
Jiangsu Province Hospital of TCM
Nanjing, Jiangsu, China
Nantong 3rd People's Hospital
Nantong, Jiangsu, China
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, China
Zhangjiagang Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University-the Eastern Division
Changchun, Jilin, China
The Second People's Hospital of Huludao
Huludao, Liaoning, China
Jinzhou Medical University
Jinzhou, Liaoning, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Neimenggu, China
Wu Yuan People's Hospital
Bayan Nur, Neimenggu, China
Affiliated Hospital of Chifeng University
Chifeng, Neimenggu, China
Huimin People's Hospital
Binzhou, Shandong, China
People's Hospital of Penglai
Dengzhou, Shandong, China
Ningjin County People's Hospital
Dezhou, Shandong, China
Shandong Provincial Western Hospital
Jinan, Shandong, China
People's Hospital of Qingdao West Coast New Area
Qingdao, Shandong, China
Qingdao Haci medical group hospital
Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Second People's Hospital of Shenzhen
Shenzhen, Shenzhen, China
Dongyang People's Hopital
Dongyang, Zhejiang, China
Lishui People's Hospital
Lishui, Zhejiang, China
No.1 People's Hospital of Taizhou
Taizhou, Zhejiang, China
Ruian People's Hospital
Wenzhou, Zhejiang, China
Countries
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References
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Gu HQ, Xie XW, Jing J, Meng X, Lv W, Yu JD, Lv XP, Li H, Wang YL, Wang YJ. Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial: rationale and design. Stroke Vasc Neurol. 2020 Sep;5(3):311-314. doi: 10.1136/svn-2019-000293. Epub 2020 Feb 27.
Other Identifiers
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2014ZX09201022-010-11
Identifier Type: -
Identifier Source: org_study_id
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