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

Phase 4

Recruiting

• Conditions: Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation
• Interventions: Drug: Anticoagulation group(Apixaban group)

• Registration Number: NCT04432220
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Study Start: 2020-07-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-06
• Primary Completion: 2026-07
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Composite outcome	24 months	composite outcome including stroke/systemic embolism and major bleeding

Secondary Outcome Measures

Name	Time	Method
Stroke	24 months	Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.
Major bleeding	24 months	The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.; 1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
Clinically Relivant Non-Major Bleeding (CRNMB)	Baseline, 1month, 6 month, 12 month, 18 month, 24 month	- Clinically Relivant Non-Major Bleeding (CRNMB) : 1. Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: 2. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1:
Death	Baseline, 1month, 6 month, 12 month, 18 month, 24 month	Death: the permanent stopping of all the vital bodily activities
Transient ischemic attack (TIA)	Baseline, 1month, 6 month, 12 month, 18 month, 24 month	TIA is brief episodes of neurological dysfunction resulting from focal cerebral ischemia not associated with permanent cerebral infarction.
Hospital admission	Baseline, 1month, 6 month, 12 month, 18 month, 24 month	Hospital admission means admission of a covered person to a hospital as an inpatient for medically necessary and appropriate care and treatment of an Illness or Injury.

Trial Locations

Locations (1)

Severance Cardiovascular Hospital Yonsei University; 🇰🇷 Seoul, Korea, Republic of