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
1 other identifier
interventional
2,416
1 country
48
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2017
Typical duration for phase_4
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedStudy Start
First participant enrolled
May 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2019
CompletedJuly 22, 2020
July 1, 2020
1.9 years
March 9, 2017
July 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptomatic or Asymptomatic New Cerebral Infarction
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.
10 days
Secondary Outcomes (8)
Symptomatic Cerebral Infarction
10 days
Asymptomatic Cerebral Infarction
10 days
Cerebral Infarction Volume Expansion
10 days
NIHSS Score Increase
10 days
Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage)
90 days
- +3 more secondary outcomes
Other Outcomes (1)
Detected an Atrial Fibrillation Persistent ≥ 30s
90 days
Study Arms (2)
Shuxuetong Injection
EXPERIMENTALShuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
Placebo Injection
PLACEBO COMPARATORPlacebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Wuhu No.1 People's Hospital
Wuhu, Anhui, China
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, 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
Related Publications (1)
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.
PMID: 32994371DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wang yongjun, MD
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Vice-President
Study Record Dates
First Submitted
March 9, 2017
First Posted
March 24, 2017
Study Start
May 12, 2017
Primary Completion
March 30, 2019
Study Completion
June 21, 2019
Last Updated
July 22, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share