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临床试验/NCT01990989
NCT01990989Unknown不适用

Clopidogrel Pharmacogenetic Score System Established for Chinese Patients

Chinese PLA General Hospital2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
2
主要终点
high on-treatment platelet reactivity (HPR)

研究概览

简要总结

The aim of the present study is to evaluate candidate variables,including Cytochrome P450 2C19(CYP2C19) genotypes, clinical and demographic variables,to establish a simple risk score that can be easily adopted by clinicians to identify patients who are at risk for HPR and composite cardiovascular outcomes in Chinese Han patients treated with dual antiplatelet therapy.

详细描述

There is a large inter-individual variability of biological antiplatelet responsiveness in patients treated with clopidogrel. Our previous study suggested that in clopidogrel treated Chinese patients with acute coronary syndromes(ACS),carriers of at least one CYP2C19 loss-of-function allele could predict greater risk of high on-treatment platelet reactivity (HPR), with the impact mainly attributing to CYP2C19*2. But as we know, CYP2C19*2 could only explain a small proportion of the variability. Various clinical and demographic variables have been considered to influence response to antiplatelet therapy.

Study objectives:

The present study aims to evaluate candidate variables,including CYP2C19 gene polymorphisms, clinical and demographic variables,to establish a simple risk score to identify patients who are at risk for HPR and composite cardiovascular outcomes .

Study design:

Step 1: Population enrollment and medication This mono-center study will be conducted in General Hospital of Chinese People's Liberation Army. Consecutive patients more than 18 years old admitted for ACS will be recruited after giving informed consents. After admission, all enrolled patients will be treated with 100 mg aspirin and 75mg clopidogrel per day. A loading dose of 300 mg clopidogrel will be given to patients undergoing coronary angiography.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

high on-treatment platelet reactivity (HPR)

时间窗: After 30 days maintenance dose of clopidogrel administration

A threshold of 50% maximal post-procedural aggregation was chosen to define HPR.

次要结局

  • Composite ischemia cardiovascular outcomes(1 year)
  • Hemorrhagic complications(1 year)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tong Yin

Research Associate of Institute of Geriatric Cardiology

Chinese PLA General Hospital

研究点 (2)

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