Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 370
- 主要终点
- Haemorrhagic complications
研究概览
简要总结
The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial.
The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Patients planned for double valve surgery
- •Patients with active endocarditis
- •Patients with atrial fibrillation/flutter
- •Patients in anticoagulation treatment of other reason.
- •Patients with previous cerebrovascular accidents or insults.
- •Patients with TCI
- •Patients with hypercoagulable conditions, disseminated intervascular coagulation, haemophilia or any other blood coagulapathy or related condition, whereby the blood coagulation process is not readily controllable
- •Patients with pacemaker
- •Any other disease than valve disease that will considerably increase the operative risk and increase the probability that the patient dies within one year after the operation, for example because of terminal cancer
- •Patients that is HIV-positive or have active AIDS
- •Patients that are known drug abuser
- •Patients in chronic haemodialysis or other types of dialysis
研究组 & 干预措施
Aspirin
Aspirin 150mg daily, starting day 1 after surgery, for three months.
干预措施: Aspirin (Drug)
Warfarin
Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.
干预措施: Warfarin (Drug)
结局指标
主要结局
Haemorrhagic complications
时间窗: 3 months
Bleeding complications
Thromboembolic complications
时间窗: 3 months
TCI, stroke, Myocardial infarction (MI), Pulmonary embolism, Deep vein thrombosis (DVT) , peripheral arterial embolism, intra-cardiac thrombus formation. We expected statistically fewer thromboembolic events in the groups receiving anticoagulation with warfarin than the aspirin only groups.
次要结局
- Registration of surgical data and postoperative complications(3 months)
- All cause mortality(3 months)
- Echocardiographic findings before surgery, before discharge and 3 months after implantation(3 months)
研究者
Nikolaj B. Lilleoer
Clinical Project Coordinator
Rigshospitalet, Denmark