Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

Phase 1

• Conditions: Cerebrovascular Disease
• Interventions: Drug: Desirable TEG; Drug: Undesirable TEG

• Registration Number: NCT03471169
• Lead Sponsor: Xuanwu Hospital, Beijing

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 Timeline

• Study Start: 2017-04-01
• Status Verified: 2017-11
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2018-03-13
• Last Update Submitted: 2018-03-13
• Study First Posted: 2018-03-20
• Last Update Posted: 2018-03-20
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desirable TEG	Desirable TEG	Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results.
Undesirable TEG	Undesirable TEG	Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results.

Primary Outcome Measures

Name	Time	Method
Efficient Aspirin	one year	The value of inhibition rate of Aspirin \> 50%

Secondary Outcome Measures

Name	Time	Method
Efficient Clopidogrel	one year	The value of adenosine diphosphate\> 30%

Trial Locations

Locations (1)

XuanWu hospital; 🇨🇳 Beijing, Xicheng, China