Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Measurement of anticoagulant activity level
研究概览
简要总结
The primary objective of the present study is to determine the clinical, biological and genetic determinants of the anticoagulant activity in patients treated with either anti-IIa or anti Xa oral anticoagulants.
The secondary objective is to determine the clinical, biological or genetic determinants of hemorrhagic or thrombotic complications during a one year follow-up.
Results will lead to a better prediction of both drug response and risk of complications.
详细描述
Direct oral anticoagulants are changing clinical practices but a better knowledge of factors that may predict both drug response and risk of complications is need.
Anticoagulant activity is influenced by different factors. Because the biological activity is not easy to measure everywhere, it is important to clearly determine factors that are involved.
A cohort of 550 patients that receive either an anti-IIa or an anti-Xa will be recruited.
The primary objective is to determine clinical, biological and genetic determinants of anticoagulant activity.
This objective will be assessed through a multivariate logistic regression (separately for anti-IIa and anti-Xa) with anticoagulant activity as dependent variable.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient receiving direct oral anticoagulant
- •Complete blood count and measure of hemostasis planned
- •Patient able to give consent
- •Patient with health insurance
排除标准
- •Patient not able to consent
- •Patient under 18 years old
- •Patient refusal
- •Patient without health insurance
结局指标
主要结局
Measurement of anticoagulant activity level
时间窗: Baseline
Multivariate analysis to determine clinical, biological or genetic predictors of anticoagulant activity level as measured by anti-IIa or anti-Xa activity
次要结局
- Occurence of any hemorrhagic complication(One year follow-up)
- Occurence of any thrombotic complication(One year follow-up)