2023-510211-20-00招募中3 期
AntiCoagulation versus AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation
Oslo University Hospital HF2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2024年10月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Hypo-attenuated leaflet thickening, superiority
研究概览
简要总结
To conduct a pragmatic randomized controlled trial assessing the optimal antithrombotic strategy in patients undergoing transcathter aortic valve implantation for aortic stenosis.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 65-80 years old
- •Successful TAVI for aortic stenosis
- •Signed informed consent form
- •Expected compliance with protocol
排除标准
- •Contraindications for any of the treatment arms
- •Strict indication for antiplatelet drugs (i.e. percutaneous coronary intervention last 12 months, or other)
- •Strict indication for oral anticoagulants (i.e. atrial fibrillation with high stroke risk, recent or recurrent venous thromboembolism, or other)
- •Unable to start study medication within 72 hours after the procedure
- •Drug interactions - Concomitant use of inhibitors of CYP3A4 and P-glycoprotein (such as the antimycotic agents ketoconazole, itraconazole, voriconazole, posaconazole and HIV-protease inhibitors) and inducers of CYP3A4 and P-glycoprotein (phenytoin, carbamazepine, phenobarbital or St. Johns wort).
结局指标
主要结局
Hypo-attenuated leaflet thickening, superiority
Hypo-attenuated leaflet thickening, superiority
Safety Composite, non-inferiority (bleeding, thromboembolic events and all-cause mortality)
Safety Composite, non-inferiority (bleeding, thromboembolic events and all-cause mortality)
次要结局
- Clinical efficacy, superiority (Composite of of Freedom from all-cause mortality, Freedom from all stroke, Freedom from hospitalization for procedure- or valve-related causes, Freedom from KCCQ overall summary score <45 or decline from baseline of >10 points)
- Safety Composite, superiority (bleeding, thromboembolic events and all-cause mortality)
- Thromboembolic events, superiority (Composite of myocardial infarction or stroke of any cause)
- Bleeding events, superiority (Bleeding events according to VARC-3 definitions)
- All-cause mortality, superiority
- Safety outcomes in safety population (adverse events, serious adverse events, individual bleeding outcomes)
- Long-term outcomes at 5 and 10 years (Major Adverse Cardiovascular Events/MACE: The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding)
研究者
Oslo universitetssykehus
Scientific
Oslo University Hospital HF
研究点 (2)
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