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

Recruiting
19 - 80 years of age
Both
Phase 4

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Overview

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study details

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

NCT04432220

Yonsei University

25 January 2024

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