Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

3500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-12-01

Brief Summary

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

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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.

Conditions

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Cerebrovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Desirable TEG

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

Group Type EXPERIMENTAL

Desirable TEG

Intervention Type DRUG

Change the type and dose of antithrombotic therapy and obtain desirable TEG results.

Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.

Undesirable TEG

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

Group Type SHAM_COMPARATOR

Undesirable TEG

Intervention Type DRUG

Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.

Interventions

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Desirable TEG

Change the type and dose of antithrombotic therapy and obtain desirable TEG results.

Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.

Intervention Type DRUG

Undesirable TEG

Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.

Intervention Type DRUG

Other Intervention Names

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blood sampling blood sampling

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

Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes