Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

Study Overview
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Brief Summary
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To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.

Detailed Description
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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.

Official Title
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Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing

Conditions
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Cerebrovascular Disease

Intervention / Treatment
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* Drug: Desirable TEG
* Drug: Undesirable TEG


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desirable TEG<br>Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results. | Drug: Desirable TEG<br>* Change the type and dose of antithrombotic therapy and obtain desirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.<br>* Other names: blood sampling;|
| Sham Comparator: Undesirable TEG<br>Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results. | Drug: Undesirable TEG<br>* Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.<br>* Other names: blood sampling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficient Aspirin | The value of inhibition rate of Aspirin > 50% | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficient Clopidogrel | The value of adenosine diphosphate> 30% | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antithrombotic therapy