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

NCT ID: NCT02606552

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-20
• Study Completion Date: 2017-06-23

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).

Conditions

Atrial Fibrillation; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dabigatran plus aspirin

Medical treatment with dabigatran plus aspirin after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy))

Group Type: ACTIVE_COMPARATOR

Dabigatrain plus aspirin

Intervention Type: DRUG

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.

Dabigatran plus clopidogrel

medical treatment with dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT)

Group Type: EXPERIMENTAL

Dabigatrain plus clopidogrel

Intervention Type: DRUG

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

Group Type: OTHER

Amplazter Cardiac Plug (ACP)

Intervention Type: DEVICE

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).

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients older than 20 years accompanying chronic atrial fibrillation with CHADS2 score ≥2

2. Patients with coronary artery disease (which requires DES) should receive the 2nd generation drug-eluting stent insertion treatment

3. 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.

4. Subjects should agree with the follow-up studies as (coronary angiography) and transesophageal echocardiography, etc.

5. Subjects should agree to follow our requests for post-operative follow-up visits.

Exclusion Criteria

1. 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.

2. Comorbidities other than atrial fibrillation that required chronic warfarin use.

3. Patients diagnosed with progressive infection condition or endocarditis.

4. Patients who have been diagnosed with progressive gastric ulcer or upper gastrointestinal bleeding for last 3 months.

5. Hemodynamically unstable patients who needs inotropic supports.

6. Senile dementia patients who have experienced any cerebrovascular accident (CVA) for last 6 weeks.

7. Patients who have been diagnosed with intracardiac mass, thrombus, or vegetation as echocardiographic findings.

8. Patients diagnosed with severe left ventricular dysfunction (<LVEF 30%).

9. 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.

10. Patients showing life expectancy less than 12 months because of noncardiac comorbidities.

11. Patients having severe vein occlusion at femoral vein, ceiling vein, or inferior vena cava.

12. A patent foramen ovale with atrial septal aneurysm and right-to-left shunt

13. Symptomatic carotid artery disease

14. Patients with severe valvular heart disease

15. Patients who are currently participating in other clinical trials for any drug or medical device.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology, Severance Cardiovascular Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1-2014-0074

Identifier Type: -

Identifier Source: org_study_id