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

Atrial Fibrillation Clinical Trial

— ATEMS-AF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03073850
• Other study ID #: KUGH12078-001
• Status: Terminated
• Phase: Phase 4
• Start date: February 23, 2017
• Est. completion date: December 15, 2019

Study information

• Verified date: September 2020
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Antiplatelet
ASA or clopidogrel
• Low dose oral anticoagulant
Edoxaban of 30mg
• Standard dose oral anticoagulant
Edoxaban of 60mg

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 year