Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-01 @ 4:09 AM
Study NCT ID:
NCT05732506
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 411}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major bleeding.', 'timeFrame': '12 months', 'description': 'Proportion of patients who had a major bleeding during the 12 months of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Stroke or systemic embolism.', 'timeFrame': '12 months', 'description': 'Proportion of patients who suffered stroke or systemic embolism during the 12 months of follow-up.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Auricular Fibrillation']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to prospectively evaluate the safety of Edoxaban.', 'detailedDescription': 'The aim of the present study is to prospectively evaluate the safety of Edoxaban in daily clinical practice in Spain in elderly patients with nonvalvular atrial fibrillation who meet the criteria for frailty and who have been prescribed the drug recently (\\<6 months prior to inclusion).\n\nThe study will provide us with a clear and real-life picture of bleeding and ischemic complications and possible treatment interruptions with Edoxaban in real life and in a large subgroup, although underrepresented in the studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients ≥75 years diagnosed with NVAF who meet frailty criteria and who have been receiving anticoagulation therapy with Edoxaban for no more than 6 months prior to study inclusion according to AEMPS recommendations and the summary of product characteristics.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 75 years of age or older with a diagnosis of NVAF.\n* Patients in whom treatment had been started in the 6 months prior to enrollment in the study with Edoxaban for prevention of stroke and systemic embolism after diagnosis of NVAF and according to the drug's technical data sheet.\n* Frailty criteria according to the FRAIL scale (score of 3 to 5 points).\n* Written informed consent to participate in the study prior to any intervention.\n\nExclusion Criteria:\n\n* Creatinine clearance according to the CKD-EPI formula less than 15 ml/min/m2\n* Moderate or severe hepatic insufficiency (Defined as grade B or C of the Child-Pugh classification.\n* Contraindication to receive Edoxaban according to the Technical Data Sheet.\n* Participation in any clinical drug trial in the 2 months prior to the initial visit.\n* Absence of recorded patient or treatment information.\n* Surgical or percutaneous occlusion of the left atrial appendage or intention to perform such intervention at the time of inclusion.\n* Any circumstance that, in the opinion of the investigator, affects patient follow-up (including life expectancy of less than two years or inability to perform follow-up).\n* Persons who are legally incapacitated or unable to understand informed consent."}, 'identificationModule': {'nctId': 'NCT05732506', 'briefTitle': 'Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria', 'organization': {'class': 'NETWORK', 'fullName': 'Galaxia Empírica'}, 'officialTitle': 'Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria', 'orgStudyIdInfo': {'id': 'EDO-FRAG-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Elderly patients diagnosed with nonvalvular atrial fibrillation who meet the frailty criteria and who had been receiving anticoagulant treatment with Edoxaban for no more than 6 months prior to inclusion in the study.', 'interventionNames': ['Drug: Edoxaban']}], 'interventions': [{'name': 'Edoxaban', 'type': 'DRUG', 'otherNames': ['Lixiana'], 'description': 'There are not intervention.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15006', 'city': 'A Coruña', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15405', 'city': 'Ferrol', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Ferrol', 'geoPoint': {'lat': 43.48451, 'lon': -8.23293}}, {'zip': '01004', 'city': 'Vitoria-Gasteiz', 'state': 'ALAVA', 'country': 'Spain', 'facility': 'Hospital Universitario de Áraba', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '02006', 'city': 'Albacete', 'state': 'Albacete', 'country': 'Spain', 'facility': 'Hospital Universitario Nuestra Señora del Perpetuo Socorro', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'zip': '03314', 'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Vega Baja', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '03293', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario del Vinalopó', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '06010', 'city': 'Badajoz', 'state': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Perpetuo Socorro', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08970', 'city': 'Sant Joan Despí', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sant Juan Despí', 'geoPoint': {'lat': 41.36718, 'lon': 2.0574}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '12540', 'city': 'Ciudad Real', 'state': 'Castellón', 'country': 'Spain', 'facility': 'Hospital Universitario de La Plana', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'zip': '10003', 'city': 'Cáceres', 'state': 'Cáceres', 'country': 'Spain', 'facility': 'Hospital San Pedro de Alcántara', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '10600', 'city': 'Plasencia', 'state': 'Cáceres', 'country': 'Spain', 'facility': 'Hospital Virgen del Puerto Plasencia', 'geoPoint': {'lat': 40.03116, 'lon': -6.08845}}, {'zip': '11510', 'city': 'Puerto Real', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital Universitario Puerto Real', 'geoPoint': {'lat': 36.52819, 'lon': -6.19011}}, {'city': 'Santiago de Compostela', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '18014', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '26006', 'city': 'Logroño', 'state': 'La Rioja', 'country': 'Spain', 'facility': 'Hospital San Pedro', 'geoPoint': {'lat': 42.46615, 'lon': -2.45115}}, {'zip': '35500', 'city': 'Arrecife', 'state': 'Las Palmas', 'country': 'Spain', 'facility': 'Hospital Universitario Doctor José Molina Orosa', 'geoPoint': {'lat': 28.96302, 'lon': -13.54769}}, {'zip': '24071', 'city': 'León', 'state': 'León', 'country': 'Spain', 'facility': 'Hospital Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '24404', 'city': 'Ponferrada', 'state': 'León', 'country': 'Spain', 'facility': 'Hospital del Bierzo', 'geoPoint': {'lat': 42.54664, 'lon': -6.59619}}, {'zip': '28905', 'city': 'Getafe', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '28006', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta De Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '28702', 'city': 'San Sebastián de los Reyes', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infanta Sofia', 'geoPoint': {'lat': 40.55555, 'lon': -3.62733}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '36214', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '33012', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Monte Naranco', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'state': 'Santa Cruz De Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario Nuestra Señora de Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Consorcio Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario y Politécnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Álvaro Hermida Ameijeiras', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galaxia Empírica', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}