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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Composite outcome [Срок оценки: Baseline]
• Composite outcome [Срок оценки: 1 month]
• Composite outcome [Срок оценки: 6 months]
• Composite outcome [Срок оценки: 12 months]
• Composite outcome [Срок оценки: 18 months]
• Composite outcome [Срок оценки: 24 months]

Вторичные конечные точки (12)

• Stroke [Срок оценки: Baseline]
• Stroke [Срок оценки: 1 month]
• Stroke [Срок оценки: 6 months]
• Stroke [Срок оценки: 12 months]
• Stroke [Срок оценки: 18 months]
• Stroke [Срок оценки: 24 months]
• Major bleeding [Срок оценки: Baseline]
• Major bleeding [Срок оценки: 1 month]
• Major bleeding [Срок оценки: 6 months]
• Major bleeding [Срок оценки: 12 months]
• Major bleeding [Срок оценки: 18 months]
• Major bleeding [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Severance Cardiovascular Hospital Yonsei University — Seoul

Публикации

• 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

Идентификаторы

NCT: NCT04432220 · 4-2020-0391

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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