NCT01305148暂停不适用
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 3,800
- 试验地点
- 112
- 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
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)
研究者
研究点 (112)
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