search
Back to results

Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism (SPACE)

Primary Purpose

Embolic Stroke

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Shuxuetong Injection
Placebo Injection
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Embolic Stroke focused on measuring Stroke, Embolic Stroke, Shuxuetong, Recurrence, Symptomatic New Cerebral Infarction, Asymptomatic New Cerebral Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. More than or equal to 18 years old and less than 80 years old;
  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

  1. Intracranial hemorrhage: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
  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.

Subgroup Exclusion Criteria

  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%.

Sites / Locations

  • Wuhu No.1 People's Hospital
  • Beijing Tian Tan Hospital, Capital Medical University
  • Ansteel Group Hospital
  • Beiujing Fengtai Youanmen Hospital
  • The First Hospital of Fangshan District
  • Yongchuan hospital of Traditional Chinese Medicine
  • Houjie Hospital
  • Cangzhou Peoole's Hospital
  • People's Hospital of Hejian
  • Kuancheng County Hospital
  • Traditional Chinese Medicine Hospital of Qiu County
  • Hengshui Fourth Hospital
  • Jizhou District Hospital of Hengshui
  • Shijiazhuang Pingan Hospital Affiliated to Hebei Medical University
  • The Second Hospital of Hebei Medical University
  • The Second Affiliated Hospital of Jiamusi University
  • Heilongjiang Province Agricultural Reclamation Mudanjiang Authority Central Hospital
  • Handan Municipal Center Hospital
  • The First Affiliated Hospital of University of South China
  • People's Hospital of Zhongmu
  • Zhengzhou Yihe Hospital Affiliated to Henan University
  • Jingmen City Hospital of Traditional Chinese Medicine
  • Wuhan NO.1 Hospital,Wuhan Hospital Of Traditional Chinese And Western Medicine
  • Jiangsu Province Hospital of TCM
  • Nantong 3rd People's Hospital
  • Zhangjiagang First People's Hospital
  • Zhangjiagang Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine
  • The Affiliated Hospital of Xuzhou Medical College
  • Jiangxi Provincial People's Hospital
  • The First Hospital of Jilin University-the Eastern Division
  • The Second People's Hospital of Huludao
  • Jinzhou Medical University
  • The First Affiliated Hospital of Baotou Medical College
  • Wu Yuan People's Hospital
  • Affiliated Hospital of Chifeng University
  • Huimin People's Hospital
  • Ningjin County People's Hospital
  • Shandong Provincial Western Hospital
  • People's Hospital of Penglai
  • People's Hospital of Qingdao West Coast New Area
  • Qingdao Haci medical group hospital
  • The Affiliated Hospital of Qingdao University
  • First Hospital of Shanxi Medical University
  • The Second People's Hospital of Shenzhen
  • Dongyang People's Hopital
  • Lishui People's Hospital
  • No.1 People's Hospital of Taizhou
  • Ruian People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Shuxuetong Injection

Placebo Injection

Arm Description

Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;

Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Symptomatic 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.
Asymptomatic Cerebral Infarction
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.
Cerebral Infarction Volume Expansion
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.
NIHSS Score Increase
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.
Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage)
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
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.
Combined Vascular Events
Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death.
Disability or Death
Disability or Death was defined as a score of 3 to 6 on the modified Rankin Scale at 90days after onset.

Full Information

First Posted
March 9, 2017
Last Updated
July 21, 2020
Sponsor
Beijing Tiantan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03090113
Brief Title
Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
Acronym
SPACE
Official Title
A Random, Double-blind, Parallel, Placebo-controlled, Multi-center Study of Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolic Stroke
Keywords
Stroke, Embolic Stroke, Shuxuetong, Recurrence, Symptomatic New Cerebral Infarction, Asymptomatic New Cerebral Infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shuxuetong Injection
Arm Type
Experimental
Arm Description
Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
Arm Title
Placebo Injection
Arm Type
Placebo Comparator
Arm Description
Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;
Intervention Type
Drug
Intervention Name(s)
Shuxuetong Injection
Other Intervention Name(s)
Shuxuetong
Intervention Description
intravenous drip
Intervention Type
Drug
Intervention Name(s)
Placebo Injection
Other Intervention Name(s)
Placebo
Intervention Description
intravenous drip
Primary Outcome Measure Information:
Title
Symptomatic or Asymptomatic New Cerebral Infarction
Description
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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Symptomatic Cerebral Infarction
Description
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.
Time Frame
10 days
Title
Asymptomatic Cerebral Infarction
Description
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.
Time Frame
10 days
Title
Cerebral Infarction Volume Expansion
Description
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.
Time Frame
10 days
Title
NIHSS Score Increase
Description
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.
Time Frame
10 days
Title
Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage)
Description
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.
Time Frame
90 days
Title
Recurrent Symptomatic Ischemic Stroke
Description
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.
Time Frame
90 days
Title
Combined Vascular Events
Description
Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death.
Time Frame
90 days
Title
Disability or Death
Description
Disability or Death was defined as a score of 3 to 6 on the modified Rankin Scale at 90days after onset.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Detected an Atrial Fibrillation Persistent ≥ 30s
Description
Pre-specified Outcomes for Substudy of 'Etiology Study in Patients with ESUS'
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang yongjun, MD
Organizational Affiliation
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wuhu No.1 People's Hospital
City
Wuhu
State/Province
Anhui
Country
China
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Ansteel Group Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beiujing Fengtai Youanmen Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Hospital of Fangshan District
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Yongchuan hospital of Traditional Chinese Medicine
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Houjie Hospital
City
Dongguan
State/Province
Guangzhou
Country
China
Facility Name
Cangzhou Peoole's Hospital
City
Cangzhou
State/Province
Hebei
Country
China
Facility Name
People's Hospital of Hejian
City
Cangzhou
State/Province
Hebei
Country
China
Facility Name
Kuancheng County Hospital
City
Chengde
State/Province
Hebei
Country
China
Facility Name
Traditional Chinese Medicine Hospital of Qiu County
City
Handan
State/Province
Hebei
Country
China
Facility Name
Hengshui Fourth Hospital
City
Hengshui
State/Province
Hebei
Country
China
Facility Name
Jizhou District Hospital of Hengshui
City
Hengshui
State/Province
Hebei
Country
China
Facility Name
Shijiazhuang Pingan Hospital Affiliated to Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The Second Affiliated Hospital of Jiamusi University
City
Jiamusi
State/Province
Heilongjiang
Country
China
Facility Name
Heilongjiang Province Agricultural Reclamation Mudanjiang Authority Central Hospital
City
Mudanjiang
State/Province
Heilongjiang
Country
China
Facility Name
Handan Municipal Center Hospital
City
Handan
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Henan
Country
China
Facility Name
People's Hospital of Zhongmu
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Zhengzhou Yihe Hospital Affiliated to Henan University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Jingmen City Hospital of Traditional Chinese Medicine
City
Jingmen
State/Province
Hubei
Country
China
Facility Name
Wuhan NO.1 Hospital,Wuhan Hospital Of Traditional Chinese And Western Medicine
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Jiangsu Province Hospital of TCM
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Nantong 3rd People's Hospital
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
Zhangjiagang First People's Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Zhangjiagang Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The First Hospital of Jilin University-the Eastern Division
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The Second People's Hospital of Huludao
City
Huludao
State/Province
Liaoning
Country
China
Facility Name
Jinzhou Medical University
City
Jinzhou
State/Province
Liaoning
Country
China
Facility Name
The First Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Neimenggu
Country
China
Facility Name
Wu Yuan People's Hospital
City
Bayan Nur
State/Province
Neimenggu
Country
China
Facility Name
Affiliated Hospital of Chifeng University
City
Chifeng
State/Province
Neimenggu
Country
China
Facility Name
Huimin People's Hospital
City
Binzhou
State/Province
Shandong
Country
China
Facility Name
Ningjin County People's Hospital
City
Dezhou
State/Province
Shandong
Country
China
Facility Name
Shandong Provincial Western Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
People's Hospital of Penglai
City
Penglai
State/Province
Shandong
Country
China
Facility Name
People's Hospital of Qingdao West Coast New Area
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Qingdao Haci medical group hospital
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
The Second People's Hospital of Shenzhen
City
Shenzhen
State/Province
Shenzhen
Country
China
Facility Name
Dongyang People's Hopital
City
Dongyang
State/Province
Zhejiang
Country
China
Facility Name
Lishui People's Hospital
City
Lishui
State/Province
Zhejiang
Country
China
Facility Name
No.1 People's Hospital of Taizhou
City
Taizhou
State/Province
Zhejiang
Country
China
Facility Name
Ruian People's Hospital
City
Wenzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32994371
Citation
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.
Results Reference
derived

Learn more about this trial

Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism

We'll reach out to this number within 24 hrs