Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
Study NCT ID:
NCT05027061
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2021-08-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Participants With Non-Valvular Atrial Fibrillation (NVAF) Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11776}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specialization of the treating physician', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of socio-demographic characteristics of NVAF participants: Age group', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of socio-demographic characteristics of NVAF participants: Gender', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of socio-demographic characteristics of NVAF participants: Body weight', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of socio-demographic characteristics of NVAF participants: Height', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI)', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of outcomes of NVAF participants: Drinking information', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of outcomes of NVAF participants: Smoking information', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of outcomes of NVAF participants: Internal medical device information', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of outcomes of NVAF participants: Degree of life freedom', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of outcomes of NVAF participants: Hospitalization/outpatient status', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of outcomes of NVAF participants: Pulse rate', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of NVAF participants: Risk factors for stroke', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of NVAF participants: Comorbidities', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of outcomes of NVAF participants: OAC prescription and administration status', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE)', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: calcium antagonist', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: Antiarrhythmic drug', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: Statin', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: H2-receptor antagonist', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: aspirin', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: P2Y12 inhibitor', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: Other antiplatelet drugs', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: Other anticoagulants', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of medication prescribed during baseline: P-glycoprotein inhibitor', 'timeFrame': 'At Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-562247', 'Apixaban', 'Atrial fibrillation', 'Oral Anticoagulants', 'Japan', 'Retrospective Study'], 'conditions': ['Non-Valvular Atrial Fibrillation (NVAF)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to understand real-world oral anticoagulants (OAC) (warfarin, apixaban, dabigatran, edoxaban and rivaroxaban) usage for non-valvular atrial fibrillation (NVAF) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population will consist of an estimated 12,000 Non-valvular atrial fibrillation (NVAF) participants' medical charts that will fulfill the study eligibility criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n• Participants received medical treatment for NVAF between 10-Jan-2012 and 31-Aug-2020.\n\nExclusion Criteria:\n\n* Had no data of serum creatinine in the participant's medical records\n* Had no data of body weight in the participant's medical records\n* Were given oral anticoagulant (OAC) for treatment of diseases other than atrial fibrillation (AF)\n\nOther protocol-defined inclusion/exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT05027061', 'briefTitle': 'A Study of Participants With Non-Valvular Atrial Fibrillation (NVAF) Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Retrospective Medical Chart Review Study for Non-valvular Atrial Fibrillation Patients Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan', 'orgStudyIdInfo': {'id': 'CV185-771'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Non-valvular atrial fibrillation (NVAF) participants receiving oral anticoagulant - Warfarin'}, {'label': 'Cohort 2', 'description': 'NVAF participants receiving oral anticoagulant - Apixaban'}, {'label': 'Cohort 3', 'description': 'NVAF participants receiving oral anticoagulant - Dabigatran'}, {'label': 'Cohort 4', 'description': 'NVAF participants receiving oral anticoagulant - Edoxaban'}, {'label': 'Cohort 5', 'description': 'NVAF participants receiving oral anticoagulant - Rivaroxaban'}, {'label': 'Cohort 6', 'description': 'NVAF participants not receiving oral anticoagulants'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070052', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}