Short-Term Anticoagulation versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 7
- 主要终点
- Primary Efficacy Endpoint: Device thrombosis as evaluated by TEE 60 days after LAAC and analyzed in a central echo core lab (as-treated analysis)
研究概览
简要总结
To compare the incidence of device thrombosis following LAAC between patients receiving short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Andes
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing successful LAAC with any approved device
- •Age≥18 years old
排除标准
- •Absolute contraindications for AC therapy
- •Absolute contraindications for antiplatelet therapy
- •End-stage renal disease (CrCl <15 ml/min)
- •Recent percutaneous revascularization with drug-eluting stents necessitating dual antiplatelet therapy
- •Prior intracranial hemorrhage
- •Contraindications for TEE
- •Severe pericardial effusion within the first 24 hrs following LAAC
- •Major/life-threatening bleeding within the first 24 hrs following LAAC
结局指标
主要结局
Primary Efficacy Endpoint: Device thrombosis as evaluated by TEE 60 days after LAAC and analyzed in a central echo core lab (as-treated analysis)
Primary Efficacy Endpoint: Device thrombosis as evaluated by TEE 60 days after LAAC and analyzed in a central echo core lab (as-treated analysis)
Primary Safety Endpoint :Adverse clinical events including all-cause mortality, stroke, bleeding, or device thrombosis* within 60 days after LAAC (intention-to-treat analysis) * As clinically evaluated and diagnosed by the center investigators and determining a treatment change
Primary Safety Endpoint :Adverse clinical events including all-cause mortality, stroke, bleeding, or device thrombosis* within 60 days after LAAC (intention-to-treat analysis) * As clinically evaluated and diagnosed by the center investigators and determining a treatment change
次要结局
- Device thrombosis as evaluated by TEE or computed tomography 12 months after LAAC
- Ischemic events (stroke, TIA) at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up
- Bleeding events at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up
研究者
Josep Rodés Cabau
Scientific
Centre Hospitalier Universite De Laval