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

Phase 4

• Conditions: Stroke; Transient Ischemic Attack
• Interventions: Drug: Butylphthalide Soft Capsules; Drug: Aspirin

• Registration Number: NCT00724724
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-07-26
• Study First Submitted QC: 2008-07-26
• Study First Posted: 2008-07-29
• Study Start: 2008-08
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24
• Primary Completion: 2011-06
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Ischemic cerebral infarction or TIA within 90 days.
2. Aged above 40 years old.
3. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
4. Stable clinical and neurological conditions.
5. Informed consent is obtained.

Exclusion Criteria

1. Intracranial hemorrhage
2. 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
3. Cardio embolism
4. Patients with anticoagulants treament including heparin or warfarin
5. 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
6. Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
7. A Modified Rankin score is more than 4
8. 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:
9. Concurrent participation in another clinical trial
10. Uncontrolled hypertension : systolic blood pressure greater than 180mmHg, or diastolic blood pressure greater than 100mmHg
11. Haemostatic disorder or thrombocytopenia (i.e., PLT<100×109/l).
12. Currently active peptic ulcer disease
13. Pregnant or breast feeding
14. Planned for major surgery, carotid endarterectomy, or carotid angioplasty
15. Unable to give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Butylphthalide Soft Capsules	Butylphthalide Soft Capsules + Aspirin
2	Aspirin	Aspirin

Primary Outcome Measures

Name	Time	Method
Small vessel disease defined by white matter lesions on MRI	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
Newly onset ischemic stroke	1 year follow up

Secondary Outcome Measures

Name	Time	Method
All-cause death	1 year follow up

Trial Locations

Locations (49)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hosptial; 🇨🇳 Beijing, Beijing, China

China Pla General Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Daxing District Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University; 🇨🇳 Beijing, Beijing, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China

China Rehabilition Research Center; 🇨🇳 Beijing, Beijing, China

General Hospital of Navy; 🇨🇳 Beijing, Beijing, China

Luhe Hospital of Tongzhou Distict Beijing; 🇨🇳 Beijing, Beijing, China

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