Evaluating anticoagulation after atrial fibrillation ablation
AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
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 |
| Enrollment | 840 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04432220 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.