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
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
