NCT04432220 AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
| NCT ID | NCT04432220 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yonsei University |
| Condition | Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 840 participants |
| Start Date | 2020-07-28 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 840 participants in total. It began in 2020-07-28 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04432220 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04432220 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04432220 currently recruiting?
Yes, NCT04432220 is actively recruiting participants. Contact the research team at cby6908@yuhs.ac for enrollment information.
Where is the NCT04432220 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT04432220 clinical trial?
NCT04432220 is sponsored by Yonsei University. The trial plans to enroll 840 participants.
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