Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Random, Double-blind, Parallel, Placebo-controlled, Multi-center Study of Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism

Conditions
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Embolic Stroke

Intervention / Treatment
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* Drug: Shuxuetong Injection
* Drug: Placebo Injection


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shuxuetong Injection<br>Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10; | Drug: Shuxuetong Injection<br>* intravenous drip<br>* Other names: Shuxuetong;|
| Placebo Comparator: Placebo Injection<br>Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10; | Drug: Placebo Injection<br>* intravenous drip<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 days | 
| 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. | 10 days | 
| 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. | 10 days | 
| 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. | 10 days | 
| 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. | 90 days | 
| 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. | 90 days | 
| Combined Vascular Events | Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death. | 90 days | 
| Disability or Death | Disability or Death was defined as a score of 3 to 6 on the modified Rankin Scale at 90days after onset. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Embolic Stroke, Shuxuetong, Recurrence, Symptomatic New Cerebral Infarction, Asymptomatic New Cerebral Infarction