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

NCT02606552 | Terminated Phase 4 DMC

• 1 other identifier: 1-2014-0074
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

drug eluting stent; atrial appendage closure

Outcome Measures

Primary Outcomes (2)

• MACCE (Major adverse cardiac and cerebrovascular events)

  5 years

• GUSTO bleeding

  5 years

Secondary Outcomes (1)

• Occurence of procedural related complications

  5 years

Study Arms (3)

Dabigatran plus aspirin

ACTIVE COMPARATOR

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

Drug: Dabigatrain plus aspirin

Dabigatran plus clopidogrel

EXPERIMENTAL

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

Drug: Dabigatrain plus clopidogrel

Amplazter Cardiac Plug (ACP)

OTHER

Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure

Device: Amplazter Cardiac Plug (ACP)

Interventions

Dabigatrain plus aspirin 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 aspirin

Dabigatrain plus clopidogrel 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.

Dabigatran plus clopidogrel

Amplazter Cardiac Plug (ACP) 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).

Amplazter Cardiac Plug (ACP)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Severance Cardiovascular Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 17, 2015
• Study Start: July 20, 2016
• Primary Completion: June 23, 2017
• Study Completion: June 23, 2017
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

KR (1)