NCT04432220RecruitingPhase 4
AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
Source: ClinicalTrials.gov · Last updated 6 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 840 (estimated)
- First submitted
- 12 Jun 2020
- Start date
- 28 Jul 2020
- Primary completion date
- Jul 2026
- Lead sponsor
- Yonsei University
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT04432220
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 840
- From 28 Jul 2020 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Malignant tumors that have not been completely cured
- Severe structural heart disease
Other
- Severe liver or kidney dysfunction
- Thyroid dysfunction
- Pregnant or breastfeeding women
- Predicted survival is less than 12 months
- Patients who do not understand the content of the study or disagree with it
Who the study is looking for
- 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
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance Cardiovascular Hospital Yonsei University Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
Related publications
- Stroke Risk-Based Anticoagulation After Atrial Fibrillation Ablation: ALONE-AF Post-Hoc Analysis.Heart Rhythm · 2026 · PMID 42887624
This page is information, not medical advice. Discuss any trial with your doctor.