Clinical trial NCT04432220: AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
Official title: AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation
Keywords: catheter ablation
anticoagulation
efficacy
safety
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 840
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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

Primary outcomes:
measure: Composite outcome
timeFrame: Baseline
measure: Composite outcome
timeFrame: 1 month
measure: Composite outcome
timeFrame: 6 months
measure: Composite outcome
timeFrame: 12 months
measure: Composite outcome
timeFrame: 18 months
measure: Composite outcome
timeFrame: 24 months
Secondary outcomes:
measure: Stroke
timeFrame: Baseline
measure: Stroke
timeFrame: 1 month
measure: Stroke
timeFrame: 6 months
measure: Stroke
timeFrame: 12 months
measure: Stroke
timeFrame: 18 months
measure: Stroke
timeFrame: 24 months
measure: Major bleeding
timeFrame: Baseline
measure: Major bleeding
timeFrame: 1 month
measure: Major bleeding
timeFrame: 6 months
measure: Major bleeding
timeFrame: 12 months
measure: Major bleeding
timeFrame: 18 months
measure: Major bleeding
timeFrame: 24 months
measure: Clinically Relivant Non-Major Bleeding (CRNMB)
timeFrame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
measure: Death
timeFrame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
measure: Transient ischemic attack (TIA)
timeFrame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
measure: Hospital admission
timeFrame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital Yonsei University
Study officials:
References: