Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation

Phase 4

Terminated

Interventions: Drug: Low dose oral anticoagulant
Drug: Antiplatelet
Drug: Standard dose oral anticoagulant

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).

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Low-dose OAC therapy	Low dose oral anticoagulant	Edoxaban of 30mg (Reduced dose of 15mg if body weight \< 60kg, CCr\< 50 ml/min, concomittant use of P-gp)
Antiplatelet therapy	Antiplatelet	acetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA
Standard-dose OAC therapy	Standard dose oral anticoagulant	Edoxaban of 60mg (Reduced dose of 30mg if body weight \< 60kg, CCr\< 50 ml/min, concomittant use of P-gp)

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

Locations (4): Korea University Anam Hospital
🇰🇷
Seoul, Korea, Republic of
Yonsei University Severance Hospital
🇰🇷
Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷
Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of

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