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

January 24, 2019 updated by: Yonsei University

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Division of Cardiology, Severance Cardiovascular Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MACCE (Major adverse cardiac and cerebrovascular events)
Time Frame: 5 years
5 years
GUSTO bleeding
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurence of procedural related complications
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 20, 2016

Primary Completion (Actual)

June 23, 2017

Study Completion (Actual)

June 23, 2017

Study Registration Dates

First Submitted

November 12, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2014-0074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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