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

Inclusion Criteria6

no recurrence of atrial fibrillation one year after catheter ablation of atrial fibrillation
CHA2DS2-VASc score \>=1 (male) or \>=2 (female)
age: 19 to 80 years
non-valvular atrial fibrillation
those who consent the study.
those who can be followed after enrollment

Exclusion Criteria7

Severe liver or kidney dysfunction
Thyroid dysfunction
Pregnant or breastfeeding women
Malignant tumors that have not been completely cured
Severe structural heart disease
Predicted survival is less than 12 months
Patients who do not understand the content of the study or disagree with it

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04432220