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Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03471169
Enrollment
3500
Registered
2018-03-20
Start date
2017-04-01
Completion date
2018-12-01
Last updated
2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disease

Keywords

antithrombotic therapy

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.

Interventions

DRUGDesirable TEG

Change the type and dose of antithrombotic therapy and obtain desirable TEG results. Antithrombotic drugs inclued Bayaspirin®,Plavix ® and Cilostazol.

DRUGUndesirable TEG

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

Sponsors

Chinese PLA General Hospital
CollaboratorOTHER
Peking University People's Hospital
CollaboratorOTHER
Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Efficient Aspirinone yearThe value of inhibition rate of Aspirin \> 50%

Secondary

MeasureTime frameDescription
Efficient Clopidogrelone yearThe value of adenosine diphosphate\> 30%

Other

MeasureTime frameDescription
Platelet aggregabilityone yearThe value of maximum extent of thrombosis around 31-47 mm

Countries

China

Contacts

Primary ContactMoli Wang, 1
yifanhahahah@163.com13801234991
Backup ContactQian Zhang, 2
zhangqian_zq@630.sina.com13911256080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026