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

NCT ID: NCT03073850

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-23
• Study Completion Date: 2019-12-15

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Antiplatelet therapy

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

Group Type: EXPERIMENTAL

Antiplatelet

Intervention Type: DRUG

ASA or clopidogrel

Low-dose OAC therapy

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

Group Type: EXPERIMENTAL

Low dose oral anticoagulant

Intervention Type: DRUG

Edoxaban of 30mg

Standard-dose OAC therapy

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

Group Type: ACTIVE_COMPARATOR

Standard dose oral anticoagulant

Intervention Type: DRUG

Edoxaban of 60mg

Interventions

Antiplatelet

ASA or clopidogrel

Intervention Type: DRUG

Low dose oral anticoagulant

Edoxaban of 30mg

Intervention Type: DRUG

Standard dose oral anticoagulant

Edoxaban of 60mg

Intervention Type: DRUG

Other Intervention Names

aspirin 100mg or clopidogrel 75mg; Edoxaban of 30mg; Edoxaban of 60mg

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hong Euy Lim, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Euy Lim, Dr.

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

Korea University Anam Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Yonsei University Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KUGH12078-001

Identifier Type: -

Identifier Source: org_study_id