NCT07431762招募中4 期
Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprosthetic Heart Valve Replacement
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,058
- 试验地点
- 3
- 主要终点
- A composite endpoint is defined as a single outcome that combines multiple clinical events; the occurrence of any one of the component events is considered as meeting the endpoint.
研究概览
简要总结
This trial is a multinational, multicenter, randomized, open-label, active-controlled clinical trial comparing the safety of aspirin versus vitamin K antagonists (warfarin) as oral antithrombotic therapy during the initial 6 months following tissue valve replacement (aortic or mitral).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 19 years with successful surgical bioprosthetic valve replacement
- •Bioprosthetic heart valve in aortic or mitral valve positions, for a day postoperatively
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Mechanical valve in any heart valve position
- •Previous hemorrhagic stroke within the last 3 months
- •Clinically overt stroke within the last 3 months
- •Current need for anticoagulation (i.e. atrial fibrillation, deep vein thrombosis)
- •Unstable postoperative conditions at index point (i.e. requirement mechanical hemodynamic support, disabling complications, stroke [ischemic, embolic], hemorrhagic stroke)
- •Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist
- •Pregnant or lactating women
研究组 & 干预措施
Aspirin
Experimental
Antiplatelet Agent
干预措施: Aspirin (Drug)
结局指标
主要结局
A composite endpoint is defined as a single outcome that combines multiple clinical events; the occurrence of any one of the component events is considered as meeting the endpoint.
时间窗: From registration to 6 months
次要结局
- Rate of all-cause mortality within 6 months(From registration to 6 months)
- Number of participants who experienced stroke within 6 months(From registration to 6 months)
- Number of participants who experienced transient ischemic attack within 6 months(From registration to 6 months)
- Number of participants who experienced systemic embolism within 6 months(From registration to 6 months)
- Number of participants who experienced myocardial infarction within 6 months(From registration to 6 months)
- Number of participants who experienced major bleeding within 6 months(From registration to 6 months)
- Number of participants with valve thrombosis at 6 months(From registration to 6 months)
研究者
Joon Bum Kim
Professor, Department of Thoracic and Cardiovascular Surgery, University of Ulsan College of Medicine
Asan Medical Center
研究点 (3)
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