Evaluating anticoagulation after atrial fibrillation ablation
Official title: AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
Run by Yonsei University · NCT04432220 · Data updated 2026-11-12
This study is testing if taking the blood thinner apixaban helps people who have had heart surgery for atrial fibrillation and are at risk for strokes, compared to not taking any blood thinner at all.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Enrollment | 840 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | July 28, 2020 |
| Main results expected | July 2026 |
| Study ends | October 2028 |
| Registry record updated | February 6, 2023 |
| Trial ID | NCT04432220 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 19 to 80 with non-valvular atrial fibrillation, a CHA2DS2-VASc score of 1 or higher for males and 2 or higher for females, who have not experienced a recurrence of atrial fibrillation for over a year after catheter ablation.
✕Probably not a fit
Patients with severe liver or kidney dysfunction, thyroid dysfunction, or those who are pregnant or breastfeeding will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the role of oral anticoagulation in patients who have undergone catheter ablation for atrial fibrillation and have maintained sinus rhythm for over a year. It is a prospective randomized trial conducted at Severance Cardiovascular Hospital in Korea, comparing the efficacy and safety of the non-vitamin K anticoagulant apixaban against no oral anticoagulation in patients at moderate to high stroke risk. Participants will be monitored for two years to assess outcomes related to stroke prevention and bleeding risks.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the management of anticoagulation in patients post-ablation, potentially reducing stroke risk without increasing bleeding complications.
How similar studies have gone: While there is limited evidence on anticoagulation post-ablation, similar studies have shown promising results in managing anticoagulation in atrial fibrillation patients, making this approach both relevant and necessary.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Severance Cardiovascular Hospital Yonsei University
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Boyoung Joung, Ph.D
- Email: cby6908@yuhs.ac
- Phone: 82-2-2228-8447
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.