The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 1,000
- 试验地点
- 49
- 主要终点
- Small vessel disease defined by white matter lesions on MRI
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
Butylphthalide Soft Capsules + Aspirin
干预措施: Butylphthalide Soft Capsules (Drug)
2
Aspirin
干预措施: Aspirin (Drug)
结局指标
主要结局
Small vessel disease defined by white matter lesions on MRI
时间窗: 1 year follow up
vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery
时间窗: 1 year follow up
Newly onset ischemic stroke
时间窗: 1 year follow up
次要结局
- All-cause death(1 year follow up)