Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT04432220
Status:
RECRUITING
Last Update Posted:
2023-02-06
First Post:
2020-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 840}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2020-06-12', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite outcome', 'timeFrame': 'Baseline', 'description': 'composite outcome including stroke/systemic embolism and major bleeding'}, {'measure': 'Composite outcome', 'timeFrame': '1 month', 'description': 'composite outcome including stroke/systemic embolism and major bleeding'}, {'measure': 'Composite outcome', 'timeFrame': '6 months', 'description': 'composite outcome including stroke/systemic embolism and major bleeding'}, {'measure': 'Composite outcome', 'timeFrame': '12 months', 'description': 'composite outcome including stroke/systemic embolism and major bleeding'}, {'measure': 'Composite outcome', 'timeFrame': '18 months', 'description': 'composite outcome including stroke/systemic embolism and major bleeding'}, {'measure': 'Composite outcome', 'timeFrame': '24 months', 'description': 'composite outcome including stroke/systemic embolism and major bleeding'}], 'secondaryOutcomes': [{'measure': 'Stroke', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Stroke', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Stroke', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Stroke', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Stroke', 'timeFrame': '18 months', 'description': '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.'}, {'measure': 'Stroke', 'timeFrame': '24 months', 'description': '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.'}, {'measure': 'Major bleeding', 'timeFrame': 'Baseline', 'description': '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.\n\n1\\. 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.'}, {'measure': 'Major bleeding', 'timeFrame': '1 month', 'description': '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.\n\n1\\. 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.'}, {'measure': 'Major bleeding', 'timeFrame': '6 months', 'description': '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.\n\n1\\. 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.'}, {'measure': 'Major bleeding', 'timeFrame': '12 months', 'description': '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.\n\n1\\. 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.'}, {'measure': 'Major bleeding', 'timeFrame': '18 months', 'description': '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.\n\n1\\. 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.'}, {'measure': 'Major bleeding', 'timeFrame': '24 months', 'description': '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.\n\n1\\. 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.'}, {'measure': 'Clinically Relivant Non-Major Bleeding (CRNMB)', 'timeFrame': 'Baseline, 1month, 6 month, 12 month, 18 month, 24 month', 'description': '\\- Clinically Relivant Non-Major Bleeding (CRNMB) :\n\n1. 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:\n2. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1:'}, {'measure': 'Death', 'timeFrame': 'Baseline, 1month, 6 month, 12 month, 18 month, 24 month', 'description': 'Death: the permanent stopping of all the vital bodily activities'}, {'measure': 'Transient ischemic attack (TIA)', 'timeFrame': 'Baseline, 1month, 6 month, 12 month, 18 month, 24 month', 'description': 'TIA is brief episodes of neurological dysfunction resulting from focal cerebral ischemia not associated with permanent cerebral infarction.'}, {'measure': 'Hospital admission', 'timeFrame': 'Baseline, 1month, 6 month, 12 month, 18 month, 24 month', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['catheter ablation', 'anticoagulation', 'efficacy', 'safety'], 'conditions': ['Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '40886309', 'type': 'DERIVED', 'citation': 'Kim D, Shim J, Choi EK, Oh IY, Kim J, Lee YS, Park J, Ko JS, Park KM, Sung JH, Park HW, Park HS, Kim JY, Kang KW, Kim D, Park JK, Kim DH, Kim JB, Yu HT, Kim TH, Uhm JS, Pak HN, Joung B; ALONE-AF Investigators. Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized Clinical Trial. JAMA. 2025 Oct 14;334(14):1246-1254. doi: 10.1001/jama.2025.14679.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'CHA2DS2-VASc score over 1point male or CHA2DS2-VASc score over 2points female.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. no recurrence of atrial fibrillation one year after catheter ablation of atrial fibrillation\n2. CHA2DS2-VASc score \\>=1 (male) or \\>=2 (female)\n3. age: 19 to 80 years\n4. non-valvular atrial fibrillation\n5. those who consent the study.\n6. those who can be followed after enrollment\n\nExclusion Criteria:\n\n1. Severe liver or kidney dysfunction\n2. Thyroid dysfunction\n3. Pregnant or breastfeeding women\n4. Malignant tumors that have not been completely cured\n5. Severe structural heart disease\n6. Predicted survival is less than 12 months\n7. Patients who do not understand the content of the study or disagree with it'}, 'identificationModule': {'nctId': 'NCT04432220', 'briefTitle': 'AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)', 'orgStudyIdInfo': {'id': '4-2020-0391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anticoagulation group(Apixaban group)', 'description': 'Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years', 'interventionNames': ['Drug: Anticoagulation group(Apixaban group)']}, {'type': 'NO_INTERVENTION', 'label': 'Nonanticoagulation group', 'description': 'Standard treatment except anticoagulant for 2 years'}], 'interventions': [{'name': 'Anticoagulation group(Apixaban group)', 'type': 'DRUG', 'description': 'Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years', 'armGroupLabels': ['Anticoagulation group(Apixaban group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Boyoung Joung, Ph.D', 'role': 'CONTACT', 'email': 'cby6908@yuhs.ac', 'phone': '82-2-2228-8447'}], 'facility': 'Severance Cardiovascular Hospital Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Boyoung Joung, Ph.D', 'role': 'CONTACT', 'email': 'cby6908@yuhs.ac', 'phone': '82-2-2228-8447'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}