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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Severance Cardiovascular Hospital Yonsei University
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.