Back to resultsSafety 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
Primary Purpose
Atrial Fibrillation, Coronary Artery Disease
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dabigatrain plus aspirin
Dabigatrain plus clopidogrel
Amplazter Cardiac Plug (ACP)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring drug eluting stent, atrial appendage closure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Division of Cardiology, Severance Cardiovascular Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Other
Arm Label
Dabigatran plus aspirin
Dabigatran plus clopidogrel
Amplazter Cardiac Plug (ACP)
Arm Description
Medical treatment with dabigatran plus aspirin after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy))
medical treatment with dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT)
Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure
Outcomes
Primary Outcome Measures
MACCE (Major adverse cardiac and cerebrovascular events)
GUSTO bleeding
Secondary Outcome Measures
Occurence of procedural related complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02606552
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
The number of patients registered for the study was low and it was expected to be difficult to derive the study results.
Study Start Date
July 20, 2016 (undefined)
Primary Completion Date
June 23, 2017 (Actual)
Study Completion Date
June 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Coronary Artery Disease
Keywords
drug eluting stent, atrial appendage closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dabigatran plus aspirin
Arm Type
Active Comparator
Arm Description
Medical treatment with dabigatran plus aspirin after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy))
Arm Title
Dabigatran plus clopidogrel
Arm Type
Experimental
Arm Description
medical treatment with dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT)
Arm Title
Amplazter Cardiac Plug (ACP)
Arm Type
Other
Arm Description
Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure
Intervention Type
Drug
Intervention Name(s)
Dabigatrain plus aspirin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dabigatrain plus clopidogrel
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Amplazter Cardiac Plug (ACP)
Intervention Description
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).
Primary Outcome Measure Information:
Title
MACCE (Major adverse cardiac and cerebrovascular events)
Time Frame
5 years
Title
GUSTO bleeding
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Occurence of procedural related complications
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Division of Cardiology, Severance Cardiovascular Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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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