2023-508532-56-00招募中3 期
Low INR to Minimize bleeding with mechanical valves Trial (LIMIT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 975
- 试验地点
- 21
- 主要终点
- Thrombosis/thromboembolism (composite of ischemic stroke, systemic thromboembolism, valve thrombosis) and major bleeding.
研究概览
简要总结
Evaluate the safety and efficacy of a common, lower INR range in patients with bileaflet aortic mechanical valves.
研究设计
- 分配方式
- Randomized
- 主要目的
- Low INR to Minimize bleeding with mechanical valves Trial (LIMIT)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Have had a bileaflet mechanical heart valve implant in the aortic position at least 3 months ago (greater than or equal to 3 months)
- •Be at least 18 years of age at the time of enrollment (greater than or equal to 18 years of age)
- •Provide written informed consent (either from the patient or substitute decision-maker)
排除标准
- •Have a second implanted mechanical valve (any position)
- •Lower boundary of planned INR range is less than 2.0
- •Pregnant or expecting to become pregnant during the study follow-up
结局指标
主要结局
Thrombosis/thromboembolism (composite of ischemic stroke, systemic thromboembolism, valve thrombosis) and major bleeding.
Thrombosis/thromboembolism (composite of ischemic stroke, systemic thromboembolism, valve thrombosis) and major bleeding.
次要结局
- All-cause mortality (selected rather than cardiovascular mortality, as cause-specific mortality is often difficult to ascertain or define in complex cardiovascular patients in whom multi-end-organ dysfunction may accompany cardiovascular decline)
- All clinically important bleeding
- Minor bleeding
- All stroke
- Ischemic stroke
- Hemorrhagic stroke
- Type 1, 2 or 3 myocardial infarction
- Systemic thromboembolism
- Valve thrombosis
- Pulmonary embolism
- Deep vein thrombosis
- New renal replacement therapy
- Time in therapeutic range
- Proportion of patients with extreme INR values (>4)
研究者
Dr. Emilie Belley-Cote
Scientific
Hamilton Health Sciences Corporation
研究点 (21)
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