Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Time to achieve stable dosing in days, since the beginning of the anticoagulation
研究概览
简要总结
The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE) due to a narrow therapeutic window leading to important medical and economical consequences. The risk of ADE is increased partly by drug interactions and recently identified genetic factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9) as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide reductase complex subunit 1 (VKORC1).
The objective is to determine the impact of several genotypes on acenocoumarol treatment and on vulnerability to drug-drug interactions.
研究设计
- 研究类型
- Observational
- 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
- •Every patients with requiring acenocoumarol therapy for at least 4 weeks and a target INR in the low intensity range (INR range 2-3)
- •Age ≥ 18 years
- •Signed informed consent
排除标准
- •Severe cognitive impairment
- •Previous or current treatment with any coumarin
结局指标
主要结局
Time to achieve stable dosing in days, since the beginning of the anticoagulation
时间窗: 5 weeks
次要结局
- Mean daily dosage of acenocoumarol(5 weeks)
- Time to achieve two consecutive therapeutic INRs(5 weeks)
- Number of patients with INR > or = 4.0, which indicates overanticoagulation(5 weeks)
- Major bleedings and minor bleedings(5 weeks)
- Thromboembolic events due to infratherapeutic anticoagulation(5 weeks)
- Length of hospitalisation in days(5 weeks)
- Potential of other drug interactions, linked to the observed genotype and phenotype of the patient(5 weeks)
研究者
Jules Desmeules
Prof
University Hospital, Geneva