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
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|ClinicalTrials.gov Identifier: NCT02606552|
Recruitment Status : Terminated (The number of patients registered for the study was low and it was expected to be difficult to derive the study results.)
First Posted : November 17, 2015
Last Update Posted : January 28, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Coronary Artery Disease||Drug: Dabigatrain plus aspirin Drug: Dabigatrain plus clopidogrel Device: Amplazter Cardiac Plug (ACP)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 20, 2016|
|Actual Primary Completion Date :||June 23, 2017|
|Actual Study Completion Date :||June 23, 2017|
Active Comparator: Dabigatran plus aspirin
Medical treatment with dabigatran plus aspirin after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy))
Drug: Dabigatrain plus aspirin
Dabigatran (Pradaxa®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with atrial fibrillation. Aspirin is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop clopidogrel (maintain dabigatran + aspirin) at 3 months after PCI.
Experimental: Dabigatran plus clopidogrel
medical treatment with dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT)
Drug: Dabigatrain plus clopidogrel
Clopidogrel is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop aspirin (maintain dabigatran + clopidogrel) at 3 months after PCI.
Amplazter Cardiac Plug (ACP)
Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure
Device: Amplazter Cardiac Plug (ACP)
Patients allocated to the intervention group should be received percutaneous closure of the LAA by use of the ACP device (St. Jude Medical, St Paul, MN, USA).
- MACCE (Major adverse cardiac and cerebrovascular events) [ Time Frame: 5 years ]
- GUSTO bleeding [ Time Frame: 5 years ]
- Occurence of procedural related complications [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606552
|Korea, Republic of|
|Division of Cardiology, Severance Cardiovascular Hospital|
|Seoul, Korea, Republic of, 120-752|