Clinical trial NCT03471169: Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease
Official title: Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cerebrovascular Disease
Keywords: antithrombotic therapy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: Peking University People's Hospital
First posted: 2018-03-20
Enrollment: 3500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficient Aspirin
timeFrame: one year
Secondary outcomes:
measure: Efficient Clopidogrel
timeFrame: one year
Other outcomes:
measure: Platelet aggregability
timeFrame: one year
Locations:
city: Beijing
country: China
facility: XuanWu hospital
state: Xicheng
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Qian Zhang, 1
role: STUDY_DIRECTOR
References: