Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2025-12-27 @ 5:28 AM
Study NCT ID:
NCT03073850
Status:
TERMINATED
Last Update Posted:
2020-09-09
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation
Sponsor:
Korea University Guro Hospital
Organization:
Study Overview
Official Title:
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (The ATEMS-AF Study)
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Majority of enrolled patients have withdrawn.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATEMS-AF
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: