Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing
试验速览
- 阶段
- 1 期
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- Efficient Aspirin
研究概览
简要总结
To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.
详细描述
Ischemic stroke is a leading cause of disability and death worldwide. Antiplatelet treatment is one of treatment strategies in secondary stroke prevention for patients with non-cardioemoblism etiology. However, a concerning issue is that wide interindividual variability in P2Y12 antagonist, especially clopidogrel. The rate on-treatment high platelet reactivity (HPR) can be as high as in one-third of patients with standard dose of clopidogrel( i.e. 75mg), and HPR has been noted in those who received other P2Y12 antagonists, such as ticagrelor and prasugrel. In the present study, we aimed to investigate the safety and potential therapeutic effect of individualized treatment of antiplatelet in secondary prevention in a cohort of patients with non-cardioembolic ischemic strokes.
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
- None
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •14 years of age or older
- •no gender aspirin or clopidogrel for ischemic cerebrovascular disease Primary or secondary prevention of ischemic stroke patients
- •The researcher (or principal) signs the informed consent form
排除标准
- •Significant head trauma or stroke in the last 3 months
- •3 months to accept intracranial, spinal surgery or other parts of large surgery
- •In the last week there is an incurable part of the artery puncture
- •Acute bleeding constitution, including platelet count <100 × 109 / L or other conditions
- •within the last 48h heparin treatment, APTT higher than the upper limit of normal range
- •Oral anticoagulant: INR> 1.7 or PT> 15s
- •The presence of intracranial tumors, aneurysms or arteriovenous malformations
- •Patients with any of the following cardioembolic-related illnesses are identified: rheumatic mitral or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, Open foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular disease not suitable for enrollment; (as determined by the investigator)
- •Severe liver and kidney dysfunction
- •Life expectancy is less than 1 year
- •Pregnant or lactating women
- •Participating in other clinical studies, or have participated in other clinical studies within the 3 months before enrolling, or have already participated in this research
- •Allergic or intolerant to aspirin or clopidogrel
- •There are stomach lesions, such as gastritis, gastric ulcer and so on
- •Do not want to follow-up or poor treatment compliance
研究组 & 干预措施
Desirable TEG
Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results.
干预措施: Desirable TEG (Drug)
Undesirable TEG
Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results.
干预措施: Undesirable TEG (Drug)
结局指标
主要结局
Efficient Aspirin
时间窗: one year
The value of inhibition rate of Aspirin \> 50%
次要结局
- Efficient Clopidogrel(one year)