Status:
UNKNOWN
The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Stroke
Transient Ischemic Attack
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00724724
Start Date
August 1 2008
End Date
August 1 2011
Last Update
February 24 2011
Active Locations (50)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
3
Peking Union Medical College Hosptial
Beijing, Beijing Municipality, China, 100730
4
China Pla General Hospital
Beijing, Beijing Municipality, China, 100853