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

  • STATUS
    Recruiting
  • End date
    Oct 24, 2028
  • participants needed
    840
  • sponsor
    Yonsei University
Updated on 24 January 2021

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.

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.

Details
Condition Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation
Treatment Anticoagulation group(Apixaban group)
Clinical Study IdentifierNCT04432220
SponsorYonsei University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 19 yrs and 80 yrs?
Gender: Male or Female
Do you have Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation?
Do you have any of these conditions: Do you have Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation??
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 Criteria

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
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