NCT01925872Unknown不适用
The Optimal Regimen of Medical Treatment in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance
Zhongrong Miao0 个研究点目标入组 2,000 人开始时间: 2013年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 主要终点
- genotype, platelet aggregation rate, cerebrovascular events
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 25 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
genotype, platelet aggregation rate, cerebrovascular events
时间窗: 2 years
Genotype means the genetic polymorphism of ABCB1, CES, CYP2C19, PON1, P2RY12, which can be determined through gene sequencing.
次要结局
- Active metabolite concentration(2 years)
研究者
Zhongrong Miao
principal investigator
Beijing Tiantan Hospital
相似试验
已完成
4 期
Clopidogrel Response and CYP2C19 Genotype in Ischemic Stroke PatientsIschemic StrokeNCT03385538Zealand University Hospital103
已完成
不适用
Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.Anti Platelet EffectsNCT01175200Ascopharm Groupe Novasco82
已完成
不适用
Resistance to Antithrombotic TherapyAngioplastyAtherosclerosisNCT00858715Medical University of Vienna46
已完成
不适用
High on Treatment Platelet Reactivity Following Peripheral Endovascular ProceduresInfluence of PRU Values on Primary OutcomeNCT01744613University of Patras100
已完成
不适用
Clopidogrel Pharmacogenetics (PGX) Bench to BedsideMetabolism of ClopidogrelNCT01341600University of Maryland, Baltimore18