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临床试验/NCT01042067
NCT01042067暂停不适用

Safer Warfarin Treatment - the Influence of CYP2C9 Genotyping, Genotyping of Vitamine K Dependent Proteins and Dietary Vitamine K Status on Dosing, Clinical Effect and Adverse Events With Emphasis on the Initial Phase of Treatment

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
200
试验地点
1

研究概览

简要总结

The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.

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

  • •Caucasian
  • •>18 years of age
  • •included in the study at the onset of warfarin treatment
  • •target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves)
  • •standard indications for warfarin treatment

排除标准

  • •Non-caucasian
  • •Clinical significant liver affection
  • •Heart failure, NYHA class III-IV
  • •Non-compliant - not able to accomplish protocol demands
  • •Not able to give informed consent
  • •Long-term antibiotic therapy
  • •Malabsorption conditions and inflammatory bowel disease

研究者

发起方
Oslo University Hospital
申办方类型
Other

研究点 (1)

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