Personalized, CT-guided antithrombotic therapy versus lifelong single antiplatelet therapy to reduce thromboembolic and bleeding events in non-atrial fibrillation patients after transcatheter aortic valve implantation: a pragmatic, international, multicentre, randomized clinical trial (POPular ATLANTIS trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,950
- 试验地点
- 33
- 主要终点
- The primary endpoints are thromboembolic and bleeding events: Thromboembolic events, defined as the composite of cardiovascular mortality, ischaemic stroke, transient ischaemic attack, myocardial infarction, systemic embolism and clinically significant valve thrombosis according to the VARC-3 criteria. All bleeding, defined as the composite of type 1-4 bleeding, according to the VARC-3 criteria.
研究概览
简要总结
To evaluate whether a personalized, CT-guided antithrombotic strategy is superior to standard care lifelong SAPT in reducing the risk of cardiovascular mortality, thromboembolic and bleeding events after TAVI in patients without an existing indication for OAC.
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
- •Successful TAVI (according to the VARC-3 criteria) with any approved device
- •Ability to understand and to comply with the study protocol
- •Written informed consent
排除标准
- •Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)
- •Creatinine clearance <30 mL/min (based on the CKD-EPI formula) or on renal replacement therapy
结局指标
主要结局
The primary endpoints are thromboembolic and bleeding events: Thromboembolic events, defined as the composite of cardiovascular mortality, ischaemic stroke, transient ischaemic attack, myocardial infarction, systemic embolism and clinically significant valve thrombosis according to the VARC-3 criteria. All bleeding, defined as the composite of type 1-4 bleeding, according to the VARC-3 criteria.
The primary endpoints are thromboembolic and bleeding events: Thromboembolic events, defined as the composite of cardiovascular mortality, ischaemic stroke, transient ischaemic attack, myocardial infarction, systemic embolism and clinically significant valve thrombosis according to the VARC-3 criteria. All bleeding, defined as the composite of type 1-4 bleeding, according to the VARC-3 criteria.
次要结局
- Net clinical benefit, defined as the composite of cardiovascular mortality, stroke, transient ischaemic attack, systemic embolism, clinically significant valve thrombosis and type 1-4 bleeding according to the VARC-3 criteria.
- Major bleeding (VARC-3 type 2-4)
- Cerebrovascular events (All stroke and TIA according to VARC-3)
- Cardiovascular mortality
- All-cause mortality
- Aortic bio-prosthetic valve dysfunction assessed by echocardiography yearly after TAVI (standard care).
- Quality of life as assessed by EuroQol- 5 Dimension 5 Level (EQ-5D-5L), Kansas City Cardiomyopathy Questionnaire (KCCQ) and Short Form Health Survey (SF-12) at baseline, 3 and 12 months, and then yearly after TAVI procedure.
- Medication adherence as assessed by the Medication Adherence Report Scale (MARS-5) yearly after randomization.
- To evaluate the cost-effectiveness of a CT-guided antithrombotic strategy after TAVI.
研究者
Christiaan Overduin
Scientific
St Antonius Hospital