Warfarin Induction Regimen Based Upon CYP2C9, VKORC1 Factor VII Genotyping, PMR and INR Monitoring, as Compared to the Conventional Regimen: a Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Maintenance dose of warfarin at steady state.
研究概览
简要总结
The response to warfarin varies greatly among individuals. Some of this variability can be ascribed to genetic polymorphisms in the gene encoding for CYP2C9, the enzyme mediating the metabolism of S warfarin. In addition genetic polymorphism in other genes (i.e. VKORC1, factor VII) have been shown to account for some of the variability in the response to warfarin irrespective of CYP2C9.The present study has several segments:
- Evaluation of the relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin maintenance dose at steady state. This study is a confirmation of previous data in our own population.
- Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.
- Testing the hypothesis that warfarin loading based on the individual's combined CYP2C9, VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse drug effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
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
- •Patients in whom warfarin is about to be initiated
- •Desired therapeutic range >2 and <3
排除标准
- •Refusal to participate in the study
研究组 & 干预措施
Genetic
干预措施: Warfarin (Drug)
Control
干预措施: Warfarin (Drug)
结局指标
主要结局
Maintenance dose of warfarin at steady state.
时间窗: 1-4 months
Time to reach pharmacodynamic steady state.
时间窗: 1-4 months
Time spent at INR <2.
时间窗: 1-4 months
Pharmacodynamic.
时间窗: 1-4 months
Time spent at INR >3.
时间窗: 1-4 months
Time spent at therapeutic INR <3 and >2.
时间窗: 1-4 months
Pharmacokinetic end points:
时间窗: 1-4 months
Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state
时间窗: 1-4 months
The incidence of minor and major bleeding episodes.
时间窗: 1-4 months
Time to reach INR > 2.
时间窗: 1-4 months
次要结局
未报告次要终点
