Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Composite of Stroke, Systemic Embolism, and Device-related Thrombosis
研究概览
简要总结
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.
详细描述
Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg) and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued indefinitely. Nonetheless, a significant number of patients continues to suffer from device-related thrombosis which carries a high risk of thromboembolic events. Other AT strategies have been tested in order to reduce the risk of thrombus-formation on device. Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients with genetic resistance to this drug has been recently reported to reduce the incidence of DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin generation compared to DAPT.
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
- 否
入选标准
- •Men and women ≥18 years of age
- •Successful LAAC procedure (device implanted without procedural or bleeding complication).
- •Patients contraindicated or unsuitable for long-term OAC.
- •History of AF (permanent or persistent or paroxysmal).
- •Written informed consent by the patient or designee if the patient is unable to consent
排除标准
- •Life expectancy < 2 years.
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
研究组 & 干预措施
Standard Antithrombotic Therapy
OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone
干预措施: ASA plus Clopidogrel (Drug)
Genetic-Tailored AntiThrombotic Strategy
OAC for 6 weeks followed by DAPT (clopidogrel responders) or aspirin plus half-dose OAC (clopidogrel non-responders) until 6 month-follow-up, then aspirin alone
干预措施: Genetic-Tailored AntiThrombotic Strategy (Drug)
Half-Dose NOAC
Half Dose of Novel OAC
干预措施: Half-Dose of novel OAC (Drug)
结局指标
主要结局
Composite of Stroke, Systemic Embolism, and Device-related Thrombosis
时间窗: 1 year
Incidence of Major Bleeding Events
时间窗: 1 year
次要结局
- Incidence of Minor Bleeding Events(1 year)
研究者
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation