跳至主要内容
临床试验/NCT00162435
NCT00162435Unknown不适用

Warfarin Induction Regimen Based Upon CYP2C9, VKORC1 Factor VII Genotyping, PMR and INR Monitoring, as Compared to the Conventional Regimen: a Prospective Controlled Study

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2002年8月最近更新:
适应症
干预措施
相关药物

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:

  1. 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.
  2. Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.
  3. 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

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

Experimental

干预措施: Warfarin (Drug)

Control

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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