Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Device thrombosis (efficacy outcome)
研究概览
简要总结
The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.
详细描述
Transcatheter left atrial appendage closure (LAAC) has emerged as an alternative to anticoagulation for preventing thromboembolic events in patients with atrial fibrillation. Whereas most complications associated with LAAC have decreased over time, the occurrence of device thrombosis remains a concern, with an incidence of 1 to 17%. Antithrombotic therapy for preventing device thrombosis following LAAC has evolved empirically, with antiplatelet therapy being the most commonly prescribed treatment. However, the rates of device thrombosis post-LAAC remain relatively high and have not decreased over time despite of increasing operator/center experience and the arrival of newer generation devices. This is of particular concern if we consider that LAAC is a preventive treatment. Experimental and mechanistic studies have suggested enhanced thrombin generation (and not platelet activation) within the days-weeks following the procedure as the most important mechanism involved in device thrombosis and appropriate short-term anticoagulation therapy with DOAC should translate into a significant reduction in the rate of device thrombosis post-LAAC.
Therefore, the objective of the study is to compare short-term (60 days) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.
It is estimated that 350 patients will take part in the study.
Update: A blinded interim analysis was performed with the analysis of clinical and TEE (central echo core lab) data from the initial 155 patients included in the study. Based on the results of the interim analysis, and considering the total number of events and the high rate (20%) of patients with either early cessation of the allocated treatment (before the 60-day TEE examination) or missing TEE at 60 days, it was decided to increase the sample size by 160 patients up to a total of 510 patients. This would ensure to include at least 350 patients with a TEE examination performed while receiving the allocated antithrombotic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Successful transcatheter LAAC with any approved device
- •Age≥18 years old
排除标准
- •Absolute contraindications for anticoagulation therapy
- •Absolute contraindications for antiplatelet therapy
- •End-stage renal disease (CrCl <15 ml/min)
- •Recent percutaneous revascularization with drug-eluting stents requiring dual antiplatelet therapy
- •Prior intracranial hemorrhage
- •Contraindications for TEE
- •Severe pericardial effusion within the first 24 hrs following LAAC
- •Major/life-threatening bleeding event within the month prior to LAAC
- •Multiple bleeding events (minor or major) within the month prior to LAAC
- •Major/life-threatening bleeding within the first 24 hrs following LAAC
研究组 & 干预措施
Anticoagulation therapy
Direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, or edoxaban; with dosage according to guideline recommendations) for 60 days.
干预措施: Rivaroxaban, dabigatran, apixaban, or edoxaban (Drug)
Antiplatelet therapy
Dual antiplatelet therapy with clopidogrel -75 mg/day- and low dose aspirin -80 to 125 mg/day for 60 days.
干预措施: Clopidogrel -75 mg/day (Drug)
Antiplatelet therapy
Dual antiplatelet therapy with clopidogrel -75 mg/day- and low dose aspirin -80 to 125 mg/day for 60 days.
干预措施: Low dose aspirin -80 to 125 mg/day- (Drug)
结局指标
主要结局
Device thrombosis (efficacy outcome)
时间窗: 60 days after LAAC
Evaluated by TEE
Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome)
时间窗: 60 days after LAAC
Clinically evaluated and diagnosed by the center investigators and determining a treatment change.
次要结局
- Device thrombosis(12 months after LAAC)
- Bleeding events(60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up)
- Major or Life-threatening bleeding events(60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up)
- Ischemic events(60 days, 12-month, 2-year, 3-year, 4-year and 5-year follow-up)
- Mortality(60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up)
研究者
Josep Rodes-Cabau
Principal Investigator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec