Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial - PILOT Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus)
研究概览
简要总结
SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device
详细描述
Background:
Transcatheter left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation in preventing cardioembolic strokes associated with atrial fibrillation. However, an optimal antithrombotic treatment regimen following successful LAAC remains an unresolved issue. The scope and duration of antiplatelet treatment following LAAC are of paramount importance as they may significantly contribute to post-procedural as well as long-term procedural safety and efficacy.
Objective:
SAFE-LAAC Trial has been designed as a comparative health effectiveness study with the following aims:
- compare the safety and efficacy of 30 days vs. 6 months of dual antiplatelet therapy following LAAC with Amplatzer or WATCHMAN device (randomized comparison)
- compare safety and efficacy of stopping all antithrombotic and antiplatelet agents 6 months after LAAC vs. long-term treatment with a single antiplatelet agent (nonrandomized comparison)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before randomization
- •Treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization
- •Participant's age 18 years or older at the time of signing the informed consent form
- •Participant is willing to follow all study procedures; especially the randomized antiplatelet treatment regimen
- •Participant is willing to sign the study informed consent form
排除标准
- •Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization)
- •Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism)
- •Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol
- •Any known inborn or acquired coagulation disorders
- •Peridevice leak >5mm on imaging study preceding enrollment
- •Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment
- •Life expectancy of fewer than 18 months
- •Participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months
- •Chronic kidney disease stage IV and V
- •Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with negative pregnancy test 24 hours prior to randomization if <55 years old) or after surgical sterilization
研究组 & 干预措施
30 days DAPT and long-term treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
干预措施: short postimplantation dual antiplatelet therapy (Drug)
30 days DAPT and long-term treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
干预措施: long-term treatment with a single antiplatelet agent (Drug)
6 months DAPT and long-term treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
干预措施: extended postimplantation dual antiplatelet therapy (Drug)
6 months DAPT and long-term treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
干预措施: long-term treatment with a single antiplatelet agent (Drug)
30 days DAPT and 6 months treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
干预措施: short postimplantation dual antiplatelet therapy (Drug)
30 days DAPT and 6 months treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
干预措施: 6 months treatment with a single antiplatelet agent (Drug)
6 months DAPT and 6 months treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
干预措施: extended postimplantation dual antiplatelet therapy (Drug)
6 months DAPT and 6 months treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
干预措施: 6 months treatment with a single antiplatelet agent (Drug)
结局指标
主要结局
Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus)
时间窗: 17 months
Event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years);
Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5)
时间窗: 17 months
Event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years);
次要结局
- All-cause mortality(17 months)
- Ischemic stroke(17 months)
- Transient ischaemic attack(17 months)
- Peripheral embolism(17 months)
- Nonfatal myocardial infarction(17 months)
- Moderate and/or severe bleeding (BARC type 2,3, and 5)(17 months)
- Left atrial appendage thrombus(17 months)
- Any bleeding(17 months)
- New moderate or major (≥4 mm) ischemic brain lesions on magnetic resonance imaging(17 months)
- Change in cognition score as detected by the Addenbrooke's cognitive examination (ACE-III)(17 months)
- Cardiovascular mortality(17 months)