Stroke, Transient Ischemic Attack
Conditions
Keywords
Stroke, Transient Ischemic Attack
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.
Interventions
Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year
DRUGAspirin
Aspirin 100mg Qd for 1 year
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| All-cause death | 1 year follow up |
Countries
China
Contacts
Primary ContactLiying Cui
Backup ContactShan Gao
Outcome results
None listed