Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-04 @ 7:26 AM
Study NCT ID:
NCT03189069
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage
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': 'C522181', 'term': 'apixaban'}, {'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major bleeding', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the risk of major bleeding and stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve Medicare Advantage patients with non-valvular atrial fibrillation (NVAF) treated with apixaban, dabigatran, rivaroxaban, or warfarin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be selected from the MORE Registry according to the inclusion/exclusion criteria. Four different cohorts will be evaluated: patients who were prescribed warfarin, apixaban, dabigatran or rivaroxaban. Only users of oral anticoagulant treatment from January 1, 2013 to January 1, 2016 will be included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had at least 1 pharmacy claim for warfarin, apixaban, dabigatran, or rivaroxaban during the identification period (01-Jan-2013 through 31-Dec-2015)\n* Had continuous health plan enrollment with medical and pharmacy benefits for 6 months pre-index date (baseline period)\n* Had continuous health plan enrollment with medical and pharmacy benefits for at least 1 month following index date\n* Had at least 1 medical claim for atrial fibrillation any time before or on index date\n\nExclusion Criteria:\n\n* Had medical claims with a diagnosis code for rheumatic mitral valvular heart disease, mitral valve stenosis or heart valve replacement/transplant during the 6-month baseline period\n* Had medical claims with a diagnosis code for dialysis, kidney transplant, or end-stage chronic kidney disease during the 6 month baseline period\n* Had medical claims indicating a diagnosis of venous thromboembolism during the 6-month baseline period\n* Had claims indicating a diagnosis or procedure code of hip or knee replacement surgery within 6 weeks prior to the index date\n* Had claims for a diagnosis or procedure code for reversible atrial fibrillation\n* Had medical claims indicating pregnancy during the study period\n* Had a pharmacy claim for warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban during the 6-month baseline period\n* Had \\> 1 oral anticoagulant prescription claim on the index date'}, 'identificationModule': {'nctId': 'NCT03189069', 'briefTitle': 'A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin', 'orgStudyIdInfo': {'id': 'CV185-583'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients prescribed apixaban', 'interventionNames': ['Drug: Apixaban']}, {'label': 'Patients prescribed dabigatran', 'interventionNames': ['Drug: Dabigatran']}, {'label': 'Patients prescribed rivaroxaban', 'interventionNames': ['Drug: Rivaroxaban']}, {'label': 'Patients prescribed warfarin', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'description': 'Treatment for NVAF patients', 'armGroupLabels': ['Patients prescribed apixaban']}, {'name': 'Dabigatran', 'type': 'DRUG', 'description': 'Treatment for NVAF patients', 'armGroupLabels': ['Patients prescribed dabigatran']}, {'name': 'Rivaroxaban', 'type': 'DRUG', 'description': 'Treatment for NVAF patients', 'armGroupLabels': ['Patients prescribed rivaroxaban']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Treatment for NVAF patients', 'armGroupLabels': ['Patients prescribed warfarin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}