Safety and Efficacy of Left Atrial Appendage Closure Versus Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-Eluting Stent Implantation Due to Complex Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- MACCE (Major adverse cardiac and cerebrovascular events)
研究概览
简要总结
Comparatively analyze the safety and validity of Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure, and the medical treatment with dabigatran plus aspirin or dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy)) in patient with coronary artery disease treated with drug-eluting stent, accompanying atrial fibrillation.
Total of 670 patients [left atrial appendage occlusion registry with 100 ACP/ 570 anti-coagulation registry: (285 Dabigatran plus aspirin) and (285 Dabigatran plus clopidogrel) therapy)] will be comparatively analyzed the safety and efficacy. Primary endpoints were a composite of death, non-fatal myocardial infarction, stroke, systemic embolism, and GUSTO bleeding (moderate to severe).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 20 years accompanying chronic atrial fibrillation with CHADS2 score ≥2
- •Patients with coronary artery disease (which requires DES) should receive the 2nd generation drug-eluting stent insertion treatment
- •Subjects and their legal representatives must understand the main purpose of this study, agree with relevant provisions, and sign to consent forms approved by IRBs of each institution.
- •Subjects should agree with the follow-up studies as (coronary angiography) and transesophageal echocardiography, etc.
- •Subjects should agree to follow our requests for post-operative follow-up visits.
排除标准
- •Patients showing any hypersensitive reaction or reason for restriction to aspirin, heparin, clopidogrel, or warfarin, or otherwise, susceptible to contrast media, and therefore, who could not use those drugs and who were pregnant or breast feeding.
- •Comorbidities other than atrial fibrillation that required chronic warfarin use.
- •Patients diagnosed with progressive infection condition or endocarditis.
- •Patients who have been diagnosed with progressive gastric ulcer or upper gastrointestinal bleeding for last 3 months.
- •Hemodynamically unstable patients who needs inotropic supports.
- •Senile dementia patients who have experienced any cerebrovascular accident (CVA) for last 6 weeks.
- •Patients who have been diagnosed with intracardiac mass, thrombus, or vegetation as echocardiographic findings.
- •Patients diagnosed with severe left ventricular dysfunction (<LVEF 30%).
- •Patients with blood disorder as followings: leucopenia (<WBC 3,000mm3), acute anemia (<Hg 9mg %), Thrombocytopenia (<100,000 platelets/mm3), or any evidence of bleeding or clotting disorders.
- •Patients showing life expectancy less than 12 months because of noncardiac comorbidities.
- •Patients having severe vein occlusion at femoral vein, ceiling vein, or inferior vena cava.
- •A patent foramen ovale with atrial septal aneurysm and right-to-left shunt
- •Symptomatic carotid artery disease
- •Patients with severe valvular heart disease
- •Patients who are currently participating in other clinical trials for any drug or medical device.
研究组 & 干预措施
Dabigatran plus aspirin
Medical treatment with dabigatran plus aspirin after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy))
干预措施: Dabigatrain plus aspirin (Drug)
Dabigatran plus clopidogrel
medical treatment with dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT)
干预措施: Dabigatrain plus clopidogrel (Drug)
Amplazter Cardiac Plug (ACP)
Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure
干预措施: Amplazter Cardiac Plug (ACP) (Device)
结局指标
主要结局
MACCE (Major adverse cardiac and cerebrovascular events)
时间窗: 5 years
GUSTO bleeding
时间窗: 5 years
次要结局
- Occurence of procedural related complications(5 years)