Determinants of Oral Anticoagulants' Activity (ANTIGOAG)
Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity
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.
研究概览
详细说明
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.
Variables that will be included in the statistical model are those known or measured at the entry in the cohort such as :
- Clinical factors : age, sex, weight, dosage and time of the last dose
- Biological factors : serum creatinine level, plasma concentration of the drug
- Genetic polymorphisms :
Factor II and CES1 for anti-IIa drugs Factor X, CYP3, CYP3A4, CYP3A5 and ABCG2 for anti-Xa drugs.
By using the same statistical approach and the same variables, predictive factors of either hemorrhagic or thrombotic events will also be evaluated on the whole cohort. The occurence of hemorrhagic and thrombotic complications will then be assessed through a phone call every 3 months during a one-year follow-up.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Lille、法国、59037
- University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patient receiving direct oral anticoagulant
- Complete blood count and measure of hemostasis planned
- Patient able to give consent
- Patient with health insurance
Exclusion Criteria:
- Patient not able to consent
- Patient under 18 years old
- Patient refusal
- Patient without health insurance
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Anti-IIa users
Determination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti IIa anticoagulant including analysis of PK-PD genetic polymorphisms
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PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
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Anti-Xa users
Determination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti Xa anticoagulant including analysis of PK-PD genetic polymorphisms
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PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Measurement of anticoagulant activity level
大体时间：Baseline
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Multivariate analysis to determine clinical, biological or genetic predictors of anticoagulant activity level as measured by anti-IIa or anti-Xa activity
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Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Occurence of any hemorrhagic complication
大体时间：One year follow-up
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Multivariate analysis to determine clinical, biological or genetic predictors of hemorrhagic complications under direct oral anticoagulant
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One year follow-up
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Occurence of any thrombotic complication
大体时间：One year follow-up
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Multivariate analysis to determine clinical, biological or genetic predictors of thrombotic complications under direct oral anticoagulant
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One year follow-up
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2014_26
- 2015-A01596-43 (其他标识符：ID-RCB number, ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
PK-PD genetic polymorphisms的临床试验
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Centre Hospitalier Universitaire de Saint Etienne完全的
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