NCT04432220

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 840 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is atrial fibrillation patients with moderate or high stroke risk (CHA2DS2-VASc\>=1 male, and \>=2 female) who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. Anticoagulation (Apixaban group) will take apixaban (5 mg bid or 2.5 mg bid according to dose guideline) for 2 years, and nonanticoagulation group will not take any oral anticoagulants for the same period. If the patients have the recurrence of AF, they will take anticoagulation according to standard treatment, and will be censored. We will analyze and compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in these patients.

Conditions

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

Interventions

Type	Name	Description
DRUG	Anticoagulation group(Apixaban group)	Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years

Timeline

• Start date: 2020-07-28
• Primary completion: 2026-07-01
• Completion: 2028-10-01
• First posted: 2020-06-16
• Last updated: 2023-02-06

Locations

1 site across 1 country: South Korea