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NCT Number: NCT04432220

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

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.

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Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Cardiovascular Hospital Yonsei University

Seoul, South Korea

Location status: Recruiting

Location contact

Boyoung Joung, Ph.D

CONTACT

[email protected]

82-2-2228-8447

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Severe liver or kidney dysfunction
  • Thyroid dysfunction
  • Pregnant or breastfeeding women
  • Malignant tumors that have not been completely cured
  • Severe structural heart disease
  • Predicted survival is less than 12 months
  • Patients who do not understand the content of the study or disagree with it

Treatment and study plan

Anticoagulation group(Apixaban group)

Drug

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

Primary outcomes

  1. Composite outcome

    Time frame: Baseline

    composite outcome including stroke/systemic embolism and major bleeding

  2. Composite outcome

    Time frame: 1 month

    composite outcome including stroke/systemic embolism and major bleeding

  3. Composite outcome

    Time frame: 6 months

    composite outcome including stroke/systemic embolism and major bleeding

  4. Composite outcome

    Time frame: 12 months

    composite outcome including stroke/systemic embolism and major bleeding

  5. Composite outcome

    Time frame: 18 months

    composite outcome including stroke/systemic embolism and major bleeding

  6. Composite outcome

    Time frame: 24 months

    composite outcome including stroke/systemic embolism and major bleeding

Secondary outcomes

  1. Stroke

    Time frame: Baseline

    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.

  2. Stroke

    Time frame: 1 month

    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.

  3. Stroke

    Time frame: 6 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.

  4. Stroke

    Time frame: 12 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.

  5. Stroke

    Time frame: 18 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.

  6. Stroke

    Time frame: 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.

  7. Major bleeding

    Time frame: Baseline

    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.

    • 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.

  8. Major bleeding

    Time frame: 1 month

    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.

    • 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.

  9. Major bleeding

    Time frame: 6 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.

    • 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.

  10. Major bleeding

    Time frame: 12 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.

    • 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.

  11. Major bleeding

    Time frame: 18 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.

    • 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.

  12. Major bleeding

    Time frame: 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.

    • 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.

  13. Clinically Relivant Non-Major Bleeding (CRNMB)

    Time frame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month

    • Clinically Relivant Non-Major Bleeding (CRNMB) :
    • 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:
    • ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1:

  14. Death

    Time frame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month

    Death: the permanent stopping of all the vital bodily activities

  15. Transient ischemic attack (TIA)

    Time frame: 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.

  16. Hospital admission

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Boyoung Joung, Ph.D

CONTACT

[email protected]

82-2-2228-8447

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Jun 16, 2020
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.