Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion: a Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of silent cerebral embolism (SCE) detected by MRI
研究概览
简要总结
The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.
详细描述
BACKGROUND Left atrial appendage intervention is increasingly recognized as an alternative strategy for thromboembolism prophylaxis in AF. Theoretically, a complete occlusion of left atrial appendage may eliminate the possibility of embolism from the appendage. However, residual risk exists due to blood stasis and endothelial dysfunction in the atrial fibrillation state. This may raise an issue that whether we should and how to give the patients after appendage occlusion long-term antithrombotic therapy.
Meanwhile, patients with AF have a high incidence of silent cerebral embolism (SCE), which has similar impact with clinical stroke on cognition function. We hypothesized that the SCE caused by micro embolism may act as part of the residual risk after appendage occlusion, thus, an optimal antithrombotic treatment to decrease the incidence of SCE remains unclear.
AIM OF THIS STUDY The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of SCE. The primary endpoint is incidence of SCE detected by MRI. The secondary endpoints are more than two new SCE detected by MRI, cognition function and composite endpoint of all-cause mortality, clinical thromboembolic events and major bleeding events.
DESIGN This is a randomized, prospective, multicenter design. We aim to include 150 patients 45 days after successful LAAC with WATCHMAN device. Patients are randomized in a 1:1 fashion into two arms: Standard Antiplatelet Therapy and Half-Dose NOAC. Follow-up duration of this study is 12 months. The 1-year routine follow-up strategy included DW-MRI scans performed approximately 90 days, 180 days, and 365 days post-procedure.
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
- Single (Outcomes Assessor)
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
- •AF patients over 18 years old
- •Patients had undergone left atrial appendage occlusion with WATCHMAN device and confirmed no significant peri-device leak or DRT at the 45-day CT
- •Patients have a history of ischemic thromboembolic events or have CHA2DS2-VASc score ≥3
排除标准
- •Patients with an indication of long-term antiplatelet therapy other than LAAO at the time of enrollment (eg, ACS, Intracranial vascular stenosis≥75%)
- •Absolute contraindications to OAC
- •Absolute contraindications to anti-platelet therapy
- •Contraindications to MR or unwilling to receiving MR
- •Patients with clinical thromboembolicor major bleeding events within 45 days after LAA occlusion
研究组 & 干预措施
Standard Antiplatelet Therapy
DAPT (aspirin 100 mg and clopidogrel 75 mg) from 45 days to 6 month-follow-up, then aspirin alone
干预措施: aspirin and clopidogrel (Drug)
Half-Dose NOAC
Long-term half-dose NOAC (rivaroxaban 10 mg after 45 days)
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Incidence of silent cerebral embolism (SCE) detected by MRI
时间窗: 45 days to 12 months
New SCE at any MRI during the follow-up
次要结局
- MoCA test(45 days to 12 months)
- Composite endpoint of of all-cause mortality, clinical thromboembolic events and major bleeding events(45 days to 12 months)
- More than two new SCE detected by MRI(45 days to 12 months)
- Cognition function detected by MMSE test(45 days to 12 months)