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

Korea University

Status and phase: Terminated; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Standard dose oral anticoagulant; Drug: Low dose oral anticoagulant; Drug: Antiplatelet

Study type: Interventional

Funder types: Other

Identifiers

NCT03073850

KUGH12078-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Antiplatelet therapy

Experimental group

Description:

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

Treatment:

Drug: Antiplatelet

Low-dose OAC therapy

Experimental group

Description:

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

Treatment:

Drug: Low dose oral anticoagulant

Standard-dose OAC therapy

Active Comparator group

Description:

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

Treatment:

Drug: Standard dose oral anticoagulant