- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03090113
Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism (SPACE)
A Random, Double-blind, Parallel, Placebo-controlled, Multi-center Study of Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Anhui
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Wuhu, Anhui, China
- Wuhu No.1 People's Hospital
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Beijing
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Beijing, Beijing, China, 100050
- Beijing Tian Tan Hospital, Capital Medical University
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Beijing, Beijing, China
- ANSTEEL Group Hospital
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Beijing, Beijing, China
- Beiujing Fengtai Youanmen Hospital
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Beijing, Beijing, China
- The First Hospital of Fangshan District
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Chongqing
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Chongqing, Chongqing, China
- Yongchuan hospital of Traditional Chinese Medicine
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Guangzhou
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Dongguan, Guangzhou, China
- Houjie Hospital
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Hebei
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Cangzhou, Hebei, China
- Cangzhou Peoole's Hospital
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Cangzhou, Hebei, China
- People's Hospital of Hejian
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Chengde, Hebei, China
- Kuancheng County Hospital
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Handan, Hebei, China
- Traditional Chinese Medicine Hospital of Qiu County
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Hengshui, Hebei, China
- Hengshui Fourth Hospital
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Hengshui, Hebei, China
- Jizhou District Hospital of Hengshui
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Shijiazhuang, Hebei, China
- The Second Hospital of Hebei Medical University
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Shijiazhuang, Hebei, China
- Shijiazhuang Pingan Hospital Affiliated to Hebei Medical University
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Heilongjiang
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Jiamusi, Heilongjiang, China
- The Second Affiliated Hospital of Jiamusi University
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Mudanjiang, Heilongjiang, China
- Heilongjiang Province Agricultural Reclamation Mudanjiang Authority Central Hospital
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Henan
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Handan, Henan, China
- Handan Municipal Center Hospital
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Hengyang, Henan, China
- The First Affiliated Hospital of University of South China
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Zhengzhou, Henan, China
- People's Hospital of Zhongmu
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Zhengzhou, Henan, China
- Zhengzhou Yihe Hospital Affiliated to Henan University
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Hubei
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Jingmen, Hubei, China
- Jingmen City Hospital of Traditional Chinese Medicine
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Wuhan, Hubei, China
- Wuhan NO.1 Hospital,Wuhan Hospital Of Traditional Chinese And Western Medicine
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Jiangsu
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Nanjing, Jiangsu, China
- Jiangsu Province Hospital of TCM
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Nantong, Jiangsu, China
- Nantong 3rd People's Hospital
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Suzhou, Jiangsu, China
- Zhangjiagang First People's Hospital
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Suzhou, Jiangsu, China
- Zhangjiagang Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine
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Xuzhou, Jiangsu, China
- The Affiliated Hospital of Xuzhou Medical College
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Jiangxi
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Nanchang, Jiangxi, China
- Jiangxi Provincial People's Hospital
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Jilin
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Changchun, Jilin, China
- The First Hospital of Jilin University-the Eastern Division
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Liaoning
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Huludao, Liaoning, China
- The Second People's Hospital of Huludao
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Jinzhou, Liaoning, China
- Jinzhou Medical University
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Neimenggu
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Baotou, Neimenggu, China
- The First Affiliated Hospital of Baotou Medical College
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Bayan Nur, Neimenggu, China
- Wu Yuan People's Hospital
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Chifeng, Neimenggu, China
- Affiliated Hospital of Chifeng University
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Shandong
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Binzhou, Shandong, China
- Huimin People's Hospital
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Dezhou, Shandong, China
- Ningjin County People's Hospital
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Jinan, Shandong, China
- Shandong Provincial Western Hospital
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Penglai, Shandong, China
- People's Hospital of Penglai
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Qingdao, Shandong, China
- The Affiliated Hospital of Qingdao University
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Qingdao, Shandong, China
- People's Hospital of Qingdao West Coast New Area
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Qingdao, Shandong, China
- Qingdao Haci medical group hospital
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Shanxi
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Taiyuan, Shanxi, China
- First Hospital of Shanxi Medical University
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Shenzhen
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Shenzhen, Shenzhen, China
- The second people's Hospital of Shenzhen
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Zhejiang
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Dongyang, Zhejiang, China
- Dongyang People's Hopital
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Lishui, Zhejiang, China
- Lishui People's Hospital
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Taizhou, Zhejiang, China
- No.1 People's Hospital of Taizhou
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Wenzhou, Zhejiang, China
- Ruian People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- More than or equal to 18 years old and less than 80 years old;
- Acute ischemic stroke, brain magnetic resonance imaging showed non lacunar infarction (subcortical infarction less than or equal to 1.5 cm);
- Onset within 72 hours;
- Patients or their family members are willing to sign the informed consent.
Exclusion criteria
- Intracranial hemorrhage: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
- Transient ischemic attack;
- Lacunar infarction;
- History of acute stroke within 6 months;
- Clear diagnosis of other causes of ischemic stroke (arterial dissection, arteritis, vasospasm, etc.);
- The acute infarcts lesion more than one-half lobe in size;
- Preceding modified Rankin Scale (mRS) score ≥ 2;
- 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;
- Chronic liver disease, liver and kidney dysfunction, lifted alanine aminotransferase (>3 times the ULN), lifted serum creatinine (>2 times the ULN);
- History of coagulopathy, systemic bleeding, thrombocytopenia or neutropenia;
- Blood pressure >90/60 mmHg or ≤220/120 mmHg after treatment;
- Serious heart or lung disease, in the judgment of clinical study staff, would not suitable to participant in the trial;
- 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
- 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;
- Known allergies for ingredients of the drug, allergy history for food or drug;
- Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;
- Participation in another clinical trial within 30 days;
- Unable to understand and/or comply with the study procedures and/or follow-up studies due to mental illness, cognitive or emotional disorders.
Subgroup Exclusion Criteria
- History of atrial fibrillation
- Atrial fibrillation in 12-lead electrocardiogram (ECG);
- Heart rate monitoring (dynamic electrocardiogram telemetry) up to 20 hours or more detected atrial fibrillation for 6 minutes or more;
- Intracardiac thrombosis in thoracic or esophageal echocardiography;
- Occlusion or proximal vessel infarction for more than 50%.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Shuxuetong Injection
Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
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intravenous drip
Other Names:
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PLACEBO_COMPARATOR: Placebo Injection
Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;
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intravenous drip
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptomatic 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.
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10 days
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Asymptomatic Cerebral Infarction
Time Frame: 10 days
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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.
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10 days
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Cerebral Infarction Volume Expansion
Time Frame: 10 days
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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.
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10 days
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NIHSS Score Increase
Time Frame: 10 days
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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.
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10 days
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Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage)
Time Frame: 90 days
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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.
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90 days
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Recurrent Symptomatic Ischemic Stroke
Time Frame: 90 days
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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.
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90 days
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Combined Vascular Events
Time Frame: 90 days
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Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death.
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90 days
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Disability or Death
Time Frame: 90 days
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Disability or Death was defined as a score of 3 to 6 on the modified Rankin Scale at 90days after onset.
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90 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detected an Atrial Fibrillation Persistent ≥ 30s
Time Frame: 90 days
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Pre-specified Outcomes for Substudy of 'Etiology Study in Patients with ESUS'
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90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wang yongjun, MD, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014ZX09201022-010-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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