NCT01925872UnknownNot Applicable
The Optimal Regimen of Medical Treatment in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance
Zhongrong Miao0 sites2,000 target enrollmentStarted: May 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,000
- Primary Endpoint
- genotype, platelet aggregation rate, cerebrovascular events
Study Overview
Brief Summary
- Clopidogrel resistance is common in patients of ischemic cerebrovascular disease.
- Genetic polymorphisms are the most important factors to clopidogrel resistance.
- The purpose of this study is to find the genes which are the related to clopidogrel resistance.
- Through gene sequencing, we can filter patient of clopidogrel resistance, so another drug maybe used to avoid the undesired efficacy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 25 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis research database.
- •90 days had a stroke or transient ischemic attack is defined as symptomatic Intracranial atherosclerotic atherosclerosis
- •stenosis ≥ 50% (MRI or CT angiography).
- •Intracranial vascular stenosis measured according to the method reported Warfarin aspirin symptomatic intracranial disease research.
Exclusion Criteria
- •diffuse intracranial arterial stenosis.
- •cranial magnetic resonance imaging shows lesions as the branch artery blockage caused.
- •non-atherosclerotic lesions.
- •occurred within 6 weeks of vascular lesions in the region of intracranial hemorrhage.
- •potential cardiac thrombus source.
- •has concurrent intracranial tumors, intracranial aneurysm or arteriovenous malformation.
- •ipsilateral extracranial carotid or vertebral artery stenosis ≥ 50%;
- •known to heparin, aspirin, clopidogrel, anesthetics and contrast agents contraindications;
- •hemoglobin less than 10g/dL, platelet count <100000/dL;
- •responsibility left after cerebral vascular-related serious neurological dysfunction (mRS ≥ 3);
- •international normalized ratio> 1.5
- •there are factors that can not be corrected by bleeding;
- •life expectancy <1 year;
- •pregnant or lactating women;
- •indications Commission determines that the patient is not suitable for the study treatment.
Outcomes
Primary Outcomes
genotype, platelet aggregation rate, cerebrovascular events
Time Frame: 2 years
Genotype means the genetic polymorphism of ABCB1, CES, CYP2C19, PON1, P2RY12, which can be determined through gene sequencing.
Secondary Outcomes
- Active metabolite concentration(2 years)
Investigators
Zhongrong Miao
principal investigator
Beijing Tiantan Hospital
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