Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT02858518
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?
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': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'classical blood sample : NFS, ionograms, CRP, TSH, albumin, vitamin D, Calcium and coagulation factors + tube for genetic study'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'scale : HEMORR2HAGES', 'timeFrame': 'at baseline', 'description': 'hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...'}, {'measure': 'scale : HAS-Bled', 'timeFrame': 'at baseline', 'description': 'arterial hypertension, renal function, liver function, cerebrovascular accident...'}, {'measure': 'scale : ATRIA', 'timeFrame': 'at baseline', 'description': 'anemia, serious kidney diseases, hypertension, antecedent...'}, {'measure': 'scale : shireman', 'timeFrame': 'at baseline', 'description': 'gender, age, hemorrhage, diabetes, anemia...'}, {'measure': 'scale charlson', 'timeFrame': 'at baseline', 'description': 'age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer'}, {'measure': 'scale : standardised geriatric assessment', 'timeFrame': 'at baseline', 'description': 'comorbidities, cognition, mobility, pain, nutrition, living environment...'}], 'secondaryOutcomes': [{'measure': 'Occurrence of major bleeding event or not major', 'timeFrame': 'at baseline and 6 months'}, {'measure': 'genotyping', 'timeFrame': 'at baseline', 'description': 'CYP2C9'}, {'measure': 'genotyping', 'timeFrame': 'at baseline', 'description': 'VKCRC1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anticoagulant'], 'conditions': ['Atrial Fibrillation', 'Gerontology']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic blood flow. It is a public health problem with 600,000 to 1 million people involved in France which 2/3 are aged over 75 years. a FA untreated exposes the patient to a significant risk of embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The anticoagulant standard treatment helps prevent the occurrence of this complication.\n\nHowever, oral anticoagulation also exposes patients to an increased risk of bleeding. The bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED, ATRIA and scores Shireman and Charlson ...).\n\nmoreover, in geriatric hospital care, every patient has a "standardized geriatric assessment" to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional status, psychological state and its environment social.\n\nThus, the objective of the investigators study was to determine the frequency of each item of each bleeding risk assessment score and geriatric assessment in patients 80 and older hospitalized geriatric ward in the department and with anticoagulant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients seniors with atrial fibrillation with anticoagulant treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalisation in geriatric unit\n* Atrial fibrillation treated by anticoagulant treatment (AVK or oral anticoagulation)\n* signed inform consent\n\nExclusion Criteria:\n\n* estimated lifetime less than 6 months\n* under guardianship or curatorship\n* without support person'}, 'identificationModule': {'nctId': 'NCT02858518', 'acronym': 'PREDIC-AGE', 'briefTitle': 'Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?', 'orgStudyIdInfo': {'id': '1408020'}, 'secondaryIdInfos': [{'id': '2014-A01664-43', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with atrial fibrillation with anticoagulant treatment', 'interventionNames': ['Other: questionnaires']}], 'interventions': [{'name': 'questionnaires', 'type': 'OTHER', 'description': 'scales : HEMORR2HAGES (hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...), HAS-Bled (arterial hypertension, renal function, liver function, cerebrovascular accident...), ATRIA (anemia, serious kidney diseases, hypertension, antecedent...), Shireman (gender, age, hemorrhage, diabetes, anemia...), Charlson (age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer) and standardised geriatric assessment (comorbidities, cognition, mobility, pain, nutrition, living environment...)', 'armGroupLabels': ['patients with atrial fibrillation with anticoagulant treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42110', 'city': 'Feurs', 'country': 'France', 'facility': 'CH de FEURS', 'geoPoint': {'lat': 45.73337, 'lon': 4.22755}}, {'zip': '42700', 'city': 'Firminy', 'country': 'France', 'facility': 'CH de FIRMINY', 'geoPoint': {'lat': 45.38956, 'lon': 4.2886}}, {'zip': '42300', 'city': 'Roanne', 'country': 'France', 'facility': 'CH de ROANNE', 'geoPoint': {'lat': 46.03624, 'lon': 4.06802}}, {'zip': '42400', 'city': 'Saint-Chamond', 'country': 'France', 'facility': 'CH de SAINT-CHAMOND', 'geoPoint': {'lat': 45.4759, 'lon': 4.51294}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de SAINT-ETIENNE', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Emilie CRAWFORD-ACHOUR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}