Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-04-12 @ 7:53 PM
Study NCT ID:
NCT02792335
Status:
COMPLETED
Last Update Posted:
2016-06-07
First Post:
2016-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients
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': 28000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discontinuation rate of patients with prior warfarin use', 'timeFrame': 'up to 31 months'}, {'measure': 'Rate of major bleeding events of patients with prior warfarin use', 'timeFrame': 'up to 31 months'}, {'measure': 'Rate of hospitalization due to major bleeding events of patients with warfarin use', 'timeFrame': 'up to 31 months'}, {'measure': 'Discontinuation rate of patients who were naïve to oral anticoagulant', 'timeFrame': 'up to 31 months'}, {'measure': 'Rate of major bleeding events of patients who were naïve to oral anticoagulant', 'timeFrame': 'up to 31 months'}, {'measure': 'Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant', 'timeFrame': 'up to 31 months'}], 'secondaryOutcomes': [{'measure': 'Rate of All-Cause Hospitalization', 'timeFrame': 'up to 31 months'}, {'measure': 'Rate of Atrial Fibrillation(AF)-Related Hospitalization', 'timeFrame': 'up to 31 months'}, {'measure': 'Rate of All-Cause Any Rehospitalization', 'timeFrame': 'up to 31 months'}, {'measure': 'Rate of AF-Related Any Rehospitalization', 'timeFrame': 'up to 31 months'}, {'measure': 'Rate of All-Cause Early Hospitalization', 'timeFrame': 'up to 31 months'}, {'measure': 'Rate of AF-Related Early Hospitalization', 'timeFrame': 'up to 31 months'}, {'measure': 'All-Cause Healthcare per patient per month (PPPM) cost', 'timeFrame': 'up to 31 months'}, {'measure': 'AF-related Healthcare per patient per month (PPPM) cost', 'timeFrame': 'up to 31 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': 'To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The initial study population will include Non-valvular atrial fibrillation (NVAF) patients who initiated warfarin or Novel oral anticoagulants (NOACs) between January 01, 2012 and August 31, 2014. The date of the first NOAC prescription claim during the enrollment period will serve as the index date. The patients who have at least 1 year of baseline data available will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with NVAF who were on warfarin and have switched to the NOACs (dabigatran, rivaroxaban and apixaban) within the study period January 01, 2013 through March 31, 2014\n* Individuals ≥18 years old on the index date\n* At least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date\n* At least 1 diagnosis of AF in the 12 months prior to index date\n* Continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date\n\nExclusion Criteria:\n\n* Individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date'}, 'identificationModule': {'nctId': 'NCT02792335', 'briefTitle': 'Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients', 'orgStudyIdInfo': {'id': 'CV185-412'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients naive to oral anticoagulant treatment', 'description': 'NVAF patients naïve to oral anticoagulant treatment (Naïve)', 'interventionNames': ['Drug: apixaban', 'Drug: dabigatran', 'Drug: rivaroxaban']}, {'label': 'patients with prior warfarin therapy', 'description': 'NVAF patients with prior warfarin therapy (Warfarin treated)', 'interventionNames': ['Drug: apixaban', 'Drug: dabigatran', 'Drug: rivaroxaban', 'Drug: warfarin']}], 'interventions': [{'name': 'apixaban', 'type': 'DRUG', 'armGroupLabels': ['patients naive to oral anticoagulant treatment', 'patients with prior warfarin therapy']}, {'name': 'dabigatran', 'type': 'DRUG', 'armGroupLabels': ['patients naive to oral anticoagulant treatment', 'patients with prior warfarin therapy']}, {'name': 'rivaroxaban', 'type': 'DRUG', 'armGroupLabels': ['patients naive to oral anticoagulant treatment', 'patients with prior warfarin therapy']}, {'name': 'warfarin', 'type': 'DRUG', 'armGroupLabels': ['patients with prior warfarin therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}