NCT04550637招募中不适用
A Multi-center Observative Study of Apixaban After Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年7月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of adverse cardiovascular events
研究概览
简要总结
The aim of the study is to enroll approximately 200 cases from 10 research centers nationwide, completed left atrial appendage occlusion (LAAO) successfully, and give apixaban (5 mg bid) postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 to 85 years;
- •understand the purpose of the trial, sign the informed consent form voluntarily
- •successful surgery (no pericardial effusion, pericardial tamponade, or device displacement during operation; no pericardial effusion before discharge), meet COST standard during operation.
- •In accordance with the indications for left atrial appendage occlusion: CHA2DS2-VAS2 score≥2 points and/or HAS-BLED score≥3 points
- •unable or unwilling to take oral anticoagulants
- •life expectancy≥1 year
排除标准
- •History of previous cardiac surgery (valve disease, cardiomyopathy, severe coronary occlusion);
- •Inability to tolerate trans-esophageal echocardiography;
- •Preoperative trans-esophageal echocardiography suggests thrombus in left atrial appendage/left atrial;
- •Patients with severe renal insufficiency (creatinine clearance rate<15ml/min);
- •Patients with liver disease accompanied by abnormal blood coagulation and clinically related bleeding risks;
- •Clinically significant active bleeding;
- •The baseline platelet count is severely reduced: PLT≤50*10^9/L;
- •Severe cardiac insufficiency (preoperative transthoracic echocardiography indicated LVEF <35%; uncontrolled heart failure (NYHA IV))
- •Allergy or contraindication to anticoagulant drugs such as aspirin, clopidogrel, apixaban, etc .;
- •Serious heart valve disease or other structural abnormalities need do elective surgical treatment; or severe coronary heart disease require limited-term intervention;
- •Less than 45kg or more than 100kg.
- •Take strong CYP3A4 and P-gp inhibitors (including pyrrole antifungal drugs, HIV protease inhibitors, etc.) for systemic treatment;
- •Patients with other diseases besides atrial fibrillation (such as after mechanical valve replacement, spontaneous or recurrent venous thromboembolism, etc.) need anticoagulation treatment;
- •Unsuccessful surgery (serious pericardial tamponade, massive bleeding and other life-threatening complications occur within 3 days after left atrial appendage closure);
- •Pregnancy or lactation;
- •Participating in other uncompleted clinical trials;
- •Investigator considers inappropriate subjects.
研究组 & 干预措施
Anticoagulant therapy after percutaneous left atrial appendage
Oral apixaban
干预措施: Oral apixaban (Drug)
结局指标
主要结局
Incidence of adverse cardiovascular events
时间窗: within 24 weeks after surgery
all cause death, stroke, transient ischemic attack, systemic embolism
次要结局
- Bleeding event(within 24 weeks after surgery)
- Hemorrhagic/ischemic stroke events(within 24 weeks after surgery)
- Incidence of deaths(witnin 24 weeks after surgery)
- Device related thrombosis(12 weeks and 24 weeks after surgery)
- Incidence of cardiovascular disease-related rehospitalization(12 weeks and 24 weeks after surgery)
- severe adverse events(12 weeks and 24 weeks after surgery)
研究者
研究点 (1)
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