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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Stroke; Transient Ischemic Attack

Treatments: Drug: Aspirin; Drug: Butylphthalide Soft Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT00724724

2006BAI01A10-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups

1

Experimental group

Description:

Butylphthalide Soft Capsules + Aspirin

Treatment:

Drug: Butylphthalide Soft Capsules

2

Active Comparator group

Description:

Aspirin

Treatment:

Drug: Aspirin