Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Cerebrovascular Disease

Treatments: Drug: Desirable TEG; Drug: Undesirable TEG

Study type: Interventional

Funder types: Other

Identifiers

NCT03471169

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Details and patient eligibility

About

To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.

Full 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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 14 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,500 participants in 2 patient groups

Desirable TEG

Experimental group

Description:

Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results.

Treatment:

Drug: Desirable TEG

Undesirable TEG

Sham Comparator group

Description:

Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results.

Treatment:

Drug: Undesirable TEG