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

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ClinicalTrials.gov Identifier: NCT03090113
Recruitment Status : Unknown
Verified November 2017 by yongjun wang, Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was:  Recruiting
First Posted : March 24, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
yongjun wang, Ministry of Science and Technology of the People´s Republic of China

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).


Condition or disease Intervention/treatment Phase
Embolic Stroke Drug: Shuxuetong Injection Drug: Placebo Injection Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Random, Double-blind, Parallel, Placebo-controlled, Multi-center Study of Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Shuxuetong Injection
Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
Drug: Shuxuetong Injection
intravenous drip
Other Name: Shuxuetong

Placebo Comparator: Placebo Injection
Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;
Drug: Placebo Injection
intravenous drip
Other Name: Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Asymptomatic 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. MRI examination including diffusion weighted imaging (DWI) sequence will be performed.

  3. Cerebral Infarction Volume Expansion [ Time Frame: 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.

  4. NIHSS Score Increase [ Time Frame: 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.

  5. Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage) [ Time Frame: 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.

  6. Recurrent Symptomatic Ischemic Stroke [ Time Frame: 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.

  7. Combined Vascular Events [ Time Frame: 90 days ]
    Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death.

  8. Disability or Death [ Time Frame: 90 days ]
    Disability or Death was defined as a score of 3 to 6 on the modified Rankin Scale at 90days after onset.


Other Outcome Measures:
  1. Detected an Atrial Fibrillation Persistent ≥ 30s [ Time Frame: 90 days ]
    Pre-specified Outcomes for Substudy of 'Etiology Study in Patients with ESUS'



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090113


Contacts
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Contact: Wang yilong, MD 00861067013383 yilong528@gmail.com
Contact: Meng xia, MD 00861067096699 mengxia45@163.com

  Show 49 Study Locations
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
Investigators
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Principal Investigator: Wang yongjun, MD Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

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Responsible Party: yongjun wang, Vice President of Beijing Tiantan Hospital, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier: NCT03090113     History of Changes
Other Study ID Numbers: 2014ZX09201022-010-11
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by yongjun wang, Ministry of Science and Technology of the People´s Republic of China:
Stroke
Embolic Stroke
Shuxuetong
Recurrence
Symptomatic New Cerebral Infarction
Asymptomatic New Cerebral Infarction
Additional relevant MeSH terms:
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Embolism
Recurrence
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Embolism and Thrombosis