The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of Butylphthalide Soft Capsules (En Bi Pu, NBP) in Secondary Prevention of Ischemic Stroke

Detailed Description
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The efficacy and safety of Butylphthalide Soft Capsules (En Bi Pu, NBP)in acute ischemic stroke has been demonstrated in China recently. Its role in secondary prevention of ischemic stroke need to be evaluated.

Official Title
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The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial

Conditions
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Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Drug: Butylphthalide Soft Capsules
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic cerebral infarction or TIA within 90 days. Aged above 40 years old. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases Stable clinical and neurological conditions. Informed consent is obtained. Exclusion Criteria: Intracranial hemorrhage Stroke of other unkonwn causes, or other known causes, such as Takayasu arteritis, Moyamoya disease, dissecting aneurysm and hypercoagulable state, carotid endarterectomy, angiogram, or cardiac surgery Cardio embolism Patients with anticoagulants treament including heparin or warfarin Severe co-morbid or unstable medical condition, ie, heart failure, respiratory failure and renal failure, severe liver dysfunction, malignancy with likelihood of death within the next 2 years Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed. A Modified Rankin score is more than 4 Abnormal liver function: ALT or AST level >1.5 times upper limit of normal; Abnormal renal function: serum creatinine level >2.0mg/dl or 177umol/l: Concurrent participation in another clinical trial Uncontrolled hypertension : systolic blood pressure greater than 180mmHg, or diastolic blood pressure greater than 100mmHg Haemostatic disorder or thrombocytopenia (i.e., PLT<100×109/l). Currently active peptic ulcer disease Pregnant or breast feeding Planned for major surgery, carotid endarterectomy, or carotid angioplasty Unable to give informed consent.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: 1<br>Butylphthalide Soft Capsules + Aspirin | Drug: Butylphthalide Soft Capsules<br>* Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year<br>* Other names: Butylphthalide Soft Capsules, En Bi Pu (NBP);|
| Active Comparator: 2<br>Aspirin | Drug: Aspirin<br>* Aspirin 100mg Qd for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newly onset ischemic stroke |  | 1 year follow up | 
| vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery |  | 1 year follow up | 
| Small vessel disease defined by white matter lesions on MRI |  | 1 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 1 year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Transient Ischemic Attack