Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 3,800
- 试验地点
- 56
- 主要终点
- Incidence of warfarin related clinical events
研究概览
简要总结
The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women at least 65 years old
- •Beginning warfarin (0 - 3 doses of warfarin taken at the time of enrollment) for a variety of diseases or conditions that require at least 30 days oral anticoagulation with target INR ≥ 2.0
排除标准
- •Unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia)
- •A previous genetically determined warfarin dose
- •The treating physician does not agree to use the recommended warfarin dose or feels that the patient should not be enrolled in the study
研究组 & 干预措施
Randomized - Genetic
Subjects who are randomized to 90 days of follow-up and whose warfarin dose was determined using the genetic information from the GenoSTAT test and clinical information through the warfarindosing.org website
干预措施: Warfarin GenoSTAT Test (Device)
Randomized - Clinical
Subjects who are randomized to 90 days of follow-up and whose warfarin dose was determined using the genetic information from clinical information alone through the warfarindosing.org website
Registry
Subjects who are followed 30 days of follow-up and whose warfarin dose was determined using the genetic information from the GenoSTAT test and clinical information through the warfarindosing.org website
干预措施: Warfarin GenoSTAT Test (Device)
结局指标
主要结局
Incidence of warfarin related clinical events
时间窗: 30 days
To determine if using warfarin-related pharmacogenetic information in calculating warfarin doses will change the incidence of warfarin-related clinical events, including major hemorrhage and thromboembolic events, at 30 days after initial dose, when compared to warfarin doses calculated without pharmacogenetic data.
次要结局
- Minor hemorrhagic events(90 days)
- Prescriber adherence(30 days)
- Warfarin Doses(90 days)
- Hemorrhagic Events(90 days)
- INR tests(30 days)
- SF-12(90 days)
- INR Tests(30 days)
- Major thromboembolic events(90 days)