Safety and Efficacy of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in the First Three Months After Mitral or Aortic Biological Valve Replacement or Repair
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Major Bleeding
研究概览
简要总结
SAFE-HEART is a single-centre, randomized controlled trial comparing the safety and efficiency of Apixaban versus Warfarin in the early period (3 months) after repair or bioprosthetics of the mitral and aortic valve cardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.
详细描述
Oral anticoagulation with vitamin K antagonists (VKAs) is currently recommended for 3 months following surgical reconstruction or bioprosthetic replacement of the mitral and aortic valves, regardless of rhythm status.
Despite their effectiveness, the use of warfarin is limited by its narrow therapeutic index, which requires frequent international normalized ratio (INR) measurements to ensure adequate anticoagulation levels. This key limitation leads to failure to maintain target INR levels and treatment discontinuation. Additionally, in the first 3 months after heart surgery, the duration of the therapeutic period is short, even with careful monitoring by experienced physicians.
Over the past decade, direct oral anticoagulants (DOACs)-factor Xa or thrombin inhibitors-have gained widespread use in anticoagulant therapy. It has been demonstrated that DOAC treatment in patients with atrial fibrillation reduces the risk of stroke or systemic embolism and carries a similar risk of major bleeding compared to VKAs during long-term follow-up in patients with atrial fibrillation. Moreover, they offer rapid onset of action, fixed dosing, no need for laboratory monitoring, and minimal interactions with food and other medications. In the postoperative period, DOAC use may also shorten hospital stays and reduce costs.
However, the safety of DOACs in the first months after surgical valve correction (reconstruction/bioprosthetic replacement of the mitral and aortic valves) remains uncertain, which is reflected in the recommendation classes for anticoagulant therapy following these procedures.
The purpose of this study is to establish whether Apixaban is as safe and effective as Warfarin in the first 3 months after reconstruction or bioprosthetics of the mitral and aortic valvescardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at the time of enrolment
- •Open heart aortic or mitral valve repair or biological valve replacement in the last 10 days
- •Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation),
- •Informed consent from either the patient or a substitute decision-maker.
排除标准
- •Mechanical valve replacement
- •Antiphospholipid syndrome (triple positive)
- •Severe renal failure (Cockcroft-Gault equation; creatinine clearance <15 ml/min)
- •Known significant liver disease (Child-Pugh classification B and C)
- •Left ventricular thrombus
- •Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis
- •Known contraindication for any DOAC or VKA
- •Women who are pregnant, breastfeeding, or of childbearing potential
- •Follow-up not possible
研究组 & 干预措施
Apixaban
Patients in the intervention group will receive Apixaban at doses recommended for the indication, adjusted for their renal function is required.
干预措施: Apixaban (Drug)
Warfarin
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
干预措施: Warfarin (Drug)
结局指标
主要结局
Major Bleeding
时间窗: 3 months
Major bleeding defined as bleeding that results in death and/or symptomatic bleeding in a critical area or organ, bleeding into a surgical site requiring reoperation, bleeding leading to hospitalization (including presentation to an acute care facility without overnight stay) and/or bleeding that causes a drop in the hemoglobin level of 20g/L or more or that which requires the transfusion of ≥2 units of packed red blood cells or whole blood (as defined by the International Society of Thrombosis and Hemostasis)
Death and/or thromboembolic complications
时间窗: 3 months
Stroke Myocardial infarction Intracardiac thrombosis Systemic embolism Deep vein thrombosis Pulmonary embolism
次要结局
- Minor Bleeding(3 months)
- Quality of Life - EQ-5D-5L(3 months)
- Patient Satisfaction with Anticoagulant treatment(3 months)
- Pleural or pericardial effusion requiring drainage(3 months)