A Phase 4 interventional study of Antiplatelet and Low dose oral anticoagulant in Atrial Fibrillation, sponsored by Korea University Guro Hospital. Terminated at 4 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Korea University Guro Hospital · Phase 4, Interventional, and Prevention
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).
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 48 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Korea University Guro Hospital is the lead sponsor of 83 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
acetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA
Drug: Antiplatelet
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 60mg (Reduced dose of 30mg if body weight \< 60kg, CCr\< 50 ml/min, concomittant use of P-gp)
Drug: Standard dose oral anticoagulant
ASA or clopidogrel
Also known as: aspirin 100mg or clopidogrel 75mg
Edoxaban of 30mg
Also known as: Edoxaban of 30mg
Edoxaban of 60mg
Also known as: Edoxaban of 60mg
Freedom rate of stroke or systemic embolism during 2 years after successful AF ablation procedure
Check stroke or systemic embolism through neurologic examination or imaging studies
Time frame: 2 year
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Korea University Guro Hospital