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ATEMS-AF: Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation

Sponsor
Korea University Guro Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03073850
Collaborator
(none)
48
Enrollment
4
Locations
3
Arms
33.7
Actual Duration (Months)
12
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate the best strategy for long-term stroke prevention in patients who have sinus rhythm after a successful catheter ablation for atrial fibrillation (AF) and who are at risk of thromboembolic events (CHA2DS2-VASc score ≥2). The investigators are going to compare antiplatelet therapy to oral anticoagulation (OAC) with different doses of edoxaban (30mg and 60mg).

Condition or Disease Intervention/Treatment Phase
  • Drug: Antiplatelet
  • Drug: Low dose oral anticoagulant
  • Drug: Standard dose oral anticoagulant
 Phase 4

Detailed Description

The investigators hypothesize that the strategy of OAC will be superior to antiplatelet therapy, but low dose edoxaban (30mg) will be non-inferior to standard dose edoxaban (60mg) for reducing the risk of stroke or systemic embolism in patients who underwent successful AF ablation. Although AF ablation is an effective therapy for reducing and/or eliminating the burden of AF, there may continue to be a risk of late recurrence or asymptomatic recurrence of atrial tachyarrhythmias. Until now, the guideline has recommended the continuation of OAC in patients who are at risk of stroke or systemic embolism based on the CHA2DS2-VASc score, even though they have maintained sinus rhythm. The annual rate of stroke, however, is still lower compared to that predicted by the scoring system, because AF ablation reduced the AF burden by 86% and the remaining episodes were significantly shorter in duration (median 6 minutes) than those pre-ablation reported by the previous study. Based on recent studies which demonstrated that both standard-dose and low-dose non-vitamin K OACs (NOAC) performed equally well with regard to the stroke prevention in patients with AF, low dose NOACs may also be sufficient for stroke prevention of briefly lasting AF episodes after successful AF ablation.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (The ATEMS-AF Study)
Actual Study Start Date :
Feb 23, 2017
Actual Primary Completion Date :
Dec 15, 2019
Actual Study Completion Date :
Dec 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antiplatelet therapy

acetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA

Drug: Antiplatelet
ASA or clopidogrel
Other Names:
  • aspirin 100mg or clopidogrel 75mg

    		•
    Experimental: Low-dose OAC therapy

    Edoxaban of 30mg (Reduced dose of 15mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)

    Drug: Low dose oral anticoagulant
    Edoxaban of 30mg
    Other Names:
  • Edoxaban of 30mg

    		•
    Active Comparator: Standard-dose OAC therapy

    Edoxaban of 60mg (Reduced dose of 30mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)

    Drug: Standard dose oral anticoagulant
    Edoxaban of 60mg
    Other Names:
  • Edoxaban of 60mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Freedom rate of stroke or systemic embolism during 2 years after successful AF ablation procedure [2 year]

      Check stroke or systemic embolism through neurologic examination or imaging studies

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients without evidence of any clinically apparent arrhythmia recurrence during at least six months after last catheter ablation of AF.

    • Willing and able to provide informed consent

    Exclusion Criteria:

    • Patients who do not meet all of the above listed inclusion criteria.

    • Patients with significant valvular heart disease or mechanical valve.

    • Patients with hypertrophic cardiomyopathy.

    • Patients with chronic renal impairment with creatinine clearance rate of < 30 mg/dl.

    • Patients with contraindication to long-term OAC.

    • Patients who had a stroke within one year prior to enrolment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Anam Hospital Seoul Korea, Republic of
    2 Korea University Guro Hospital Seoul Korea, Republic of
    3 Seoul National University Hospital Seoul Korea, Republic of
    4 Yonsei University Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Korea University Guro Hospital

    Investigators

    • Principal Investigator: Hong Euy Lim, Dr., Korea University Guro Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hong Euy Lim, MD, Professor, Korea University Guro Hospital
    ClinicalTrials.gov Identifier:
    NCT03073850
    Other Study ID Numbers:
    • KUGH12078-001
    First Posted:
    Mar 8, 2017
    Last Update Posted:
    Sep 9, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Aspirin
    Edoxaban
    Anticoagulants
    Clopidogrel

    Study Results

    No Results Posted as of Sep 9, 2020