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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-28

Study Completion Date

2028-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation

NCT03108872

Atrial Fibrillation

UNKNOWN

Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation

NCT02504177

Atrial Fibrillation

UNKNOWN NA

Treatment of Atrial Fibrillation by Minimal Invasive Surgery

NCT00448656

Atrial Fibrillation

COMPLETED PHASE2

LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.

NCT06021808

Non-paroxysmal Atrial Fibrillation

RECRUITING NA

Use of Anticoagulant, and Associated Factors of Anticoagulant Refusal Atrial Fibrillation Patients

NCT04062071

Atrial Fibrillation

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is atrial fibrillation patients with moderate or high stroke risk (CHA2DS2-VASc\>=1 male, and \>=2 female) who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. Anticoagulation (Apixaban group) will take apixaban (5 mg bid or 2.5 mg bid according to dose guideline) for 2 years, and nonanticoagulation group will not take any oral anticoagulants for the same period. If the patients have the recurrence of AF, they will take anticoagulation according to standard treatment, and will be censored. We will analyze and compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in these patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anticoagulation group(Apixaban group)

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

Group Type EXPERIMENTAL

Anticoagulation group(Apixaban group)

Intervention Type DRUG

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

Nonanticoagulation group

Standard treatment except anticoagulant for 2 years

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anticoagulation group(Apixaban group)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No