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Clinical Trials in South Korea / NCT04432220
Recruiting Phase 4

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

NCT04432220 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Phase 4
Started
2020-07-28
Last updated
2023-02-06

Condition(s) studied

Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation

Investigational drug(s) / intervention(s)

Anticoagulation group(Apixaban group)

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

Study 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

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite outcome — Baseline
    composite outcome including stroke/systemic embolism and major bleeding
  • Composite outcome — 1 month
    composite outcome including stroke/systemic embolism and major bleeding
  • Composite outcome — 6 months
    composite outcome including stroke/systemic embolism and major bleeding
  • Composite outcome — 12 months
    composite outcome including stroke/systemic embolism and major bleeding
  • Composite outcome — 18 months
    composite outcome including stroke/systemic embolism and major bleeding
  • Composite outcome — 24 months
    composite outcome including stroke/systemic embolism and major bleeding

Trial sites (1)

FacilityCityRegionStatus
Severance Cardiovascular Hospital Yonsei University Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04432220 on ClinicalTrials.gov ↗ ← All trials in South Korea