Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing
Overview
- Phase
- Phase 1
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 3,500
- Locations
- 1
- Primary Endpoint
- Efficient Aspirin
Overview
Brief Summary
To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Desirable TEG
Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results.
Intervention: Desirable TEG (Drug)
Undesirable TEG
Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results.
Intervention: Undesirable TEG (Drug)
Outcomes
Primary Outcomes
Efficient Aspirin
Time Frame: one year
The value of inhibition rate of Aspirin \> 50%
Secondary Outcomes
- Efficient Clopidogrel(one year)