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Recruiting NCT04432220

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anticoagulation group(Apixaban group).
Who it may be relevant to
Registry conditions: Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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.

Interventions

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

Primary outcome measures

  • Composite outcome [Time frame: Baseline]
  • Composite outcome [Time frame: 1 month]
  • Composite outcome [Time frame: 6 months]
  • Composite outcome [Time frame: 12 months]
  • Composite outcome [Time frame: 18 months]
  • Composite outcome [Time frame: 24 months]
Secondary outcome measures (12)
  • Stroke [Time frame: Baseline]
  • Stroke [Time frame: 1 month]
  • Stroke [Time frame: 6 months]
  • Stroke [Time frame: 12 months]
  • Stroke [Time frame: 18 months]
  • Stroke [Time frame: 24 months]
  • Major bleeding [Time frame: Baseline]
  • Major bleeding [Time frame: 1 month]
  • Major bleeding [Time frame: 6 months]
  • Major bleeding [Time frame: 12 months]
  • Major bleeding [Time frame: 18 months]
  • Major bleeding [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Severance Cardiovascular Hospital Yonsei University — Seoul

Publications

  • Kim D, Shim J, Choi EK, Oh IY, Kim J, Lee YS, Park J, Ko JS, Park KM, Sung JH, Park HW, Park HS, Kim JY, Kang KW, Kim D, Park JK, Kim DH, Kim JB, Yu HT, Kim TH, Uhm JS, Pak HN, Joung B; ALONE-AF Investigators. Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized Clinical Trial. JAMA. 2025 Oct 14;334(14):1246-1254. doi: 10.1001/jama.2025 PMID 40886309

Identifiers

NCT: NCT04432220 · 4-2020-0391

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗