Association Between Risk Scores for Genetic Variants and Percentage of Time in Therapeutic Range for Participants With Atrial Fibrillation, Deep Vein Thrombosis, and/or Intracardiac Thrombosis Taking Warfarin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percent time in therapeutic range during initial 12 weeks of warfarin
研究概览
简要总结
Study objective is to determine whether there is an association between genetic variant risk scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥ 4, bleeding event, ischemic stroke, death) in participants taking warfarin for atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE), and/or intracardiac thrombosis.
详细描述
It is anticipated that next generation genomic sequencing will identify rare genetic variants in ethnically diverse populations, which otherwise would not have been detected using commercially available warfarin tests. Furthermore, retrospective review of clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥ 4, major bleeding event, ischemic stroke) of study participants will determine the clinical utility of genetic variant risk scores. Study outcomes will provide guidance on future directions for optimizing dosing algorithms for warfarin that combine pharmacogenetic principles with clinical dosing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-valvular atrial fibrillation
- •Deep venous thrombosis (DVT) and/or pulmonary embolism (PE) with no hypercoagulable condition
- •Non-valvular atrial fibrillation and DVT/PE (with no hypercoagulable condition)
- •Intracardiac thrombosis (i.e. apical thrombosis, atrial thrombosis, auricular thrombosis, mural thrombosis, and/or ventricular thrombosis)
- •Age 18-99 years
- •Signed informed consent
排除标准
- •Presence of a mechanical heart valve
- •Failure to provide signed informed consent
- •Known diseases that affects coagulation test results such as vitamin K deficiency, disseminated intravascular coagulopathy, Von Willebrand disease, hemophilia, liver failure, etc.
结局指标
主要结局
Percent time in therapeutic range during initial 12 weeks of warfarin
时间窗: 12 weeks
Within the 12 weeks of treatment, this is the percentage of time that a given participant is within the therapeutic range (e.g. participant is in therapeutic range 75% of time/12 weeks of measurement)
次要结局
- INR ≥ 4.0 during first 12 weeks of warfarin therapy(12 weeks)
- Ischemic stroke(12 weeks)
- Time to reach therapeutic INR(12 weeks)
- Major bleeding event during first 12 weeks of warfarin therapy(12 weeks)
- Clinically relevant non-major bleeding event during the first 12 weeks of warfarin therapy(12 weeks)