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

Last updated: January 24, 2019
Sponsor: Yonsei University
Overall Status: Terminated

Phase

4

Condition

Hypercholesterolemia

Chest Pain

Thrombosis

Treatment

N/A

Clinical Study ID

NCT02606552
1-2014-0074
  • Ages > 20
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients older than 20 years accompanying chronic atrial fibrillation with CHADS2score ≥2

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

  3. Subjects and their legal representatives must understand the main purpose of thisstudy, agree with relevant provisions, and sign to consent forms approved by IRBs ofeach institution.

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

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

Exclusion

Exclusion Criteria:

  1. Patients showing any hypersensitive reaction or reason for restriction to aspirin,heparin, clopidogrel, or warfarin, or otherwise, susceptible to contrast media, andtherefore, 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 uppergastrointestinal bleeding for last 3 months.

  5. Hemodynamically unstable patients who needs inotropic supports.

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

  7. Patients who have been diagnosed with intracardiac mass, thrombus, or vegetation asechocardiographic 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 orclotting disorders.

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

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

  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 ormedical device.

Study Design

Total Participants: 9
Study Start date:
July 20, 2016
Estimated Completion Date:
June 23, 2017

Connect with a study center

  • Division of Cardiology, Severance Cardiovascular Hospital

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.