RecruitingPhase 4NCT04432220

AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)

Sponsor

Yonsei University

Enrollment

840 participants

Start Date

Jul 28, 2020

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation

Summary

There has no evidence for the anticoagulation in patients who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. However, anticoagulation can increase the risk of bleeding, the study evaluating the role of oral anticoagulation is needed in this patients. This study will compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in patient with sinus rhythm one year after catheter ablation of AF.

Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people with atrial fibrillation (an irregular heart rhythm) who have had a successful ablation procedure still need to continue taking blood thinners one year after the procedure. **You may be eligible if...** - You are between 19 and 80 years old - You had a catheter ablation for atrial fibrillation and have had no recurrence of the irregular rhythm for one year - You have at least one stroke risk factor (based on a score called CHA2DS2-VASc) - You do not have a mechanical heart valve **You may NOT be eligible if...** - You have severe liver or kidney disease - You have a thyroid disorder - You are pregnant or breastfeeding - You have a serious untreated cancer - You have severe structural heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnticoagulation group(Apixaban group)

Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years

Locations(1)

Severance Cardiovascular Hospital Yonsei University

Seoul, South Korea

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NCT04432220