Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-31 @ 1:47 AM
Study NCT ID:
NCT02591732
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2015-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Nationwide Registry Study of Patients With Nonvalvular Atrial Fibrillation Initiating Oral Anticoagulation Therapies In The Early Period Following Apixaban Marketing In Denmark
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2015-10-08', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sociodemographic characteristics of all patients with nonvalvular atrial fibrillation (NVAF) who initiated an OAT based on data available in Danish National Patient Registry', 'timeFrame': 'Approximately 4 years', 'description': 'Sociodemographic characteristics: Age,sex, ethnicity, region of residence, education, income and employment status'}, {'measure': 'Clinical characteristics of all patients with NVAF who initiated an Oral anticoagulant therapy (OAT) based on data available in Danish National Patient Registry', 'timeFrame': 'Approximately 4 years', 'description': 'Clinical characteristics: Myocardial infarction, Stroke, Thromboembolism, Hypertension, Peripheral artery disease, Congestive cardiac failure'}, {'measure': 'Previous Oral anticoagulant therapy of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry', 'timeFrame': 'Approximately 4 years', 'description': 'Oral anticoagulant: Apixaban, Dabigatran, Rivaroxaban and Vitamin K antagonist'}, {'measure': 'Concomitant medications of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry', 'timeFrame': 'Approximately 4 years', 'description': 'Concomitant medication Drug classes: Anti-arrhythmic agents, Antidiabetic agents, Antihypertensive agents, Proton pump inhibitors'}], 'secondaryOutcomes': [{'measure': 'Persistence to each OAT after initiation as monotherapy', 'timeFrame': 'Approximately 4 years', 'description': 'Persistence will be defined as treatment discontinuation and will be measured by estimating the following:\n\nDiscontinuation - the absence of any delivery of this product and of any other anticoagulation therapy of interest for 30 days. The date of discontinuation the OAT will be determined according to predefined algorithms to calculate treatment duration in the national prescription registry. Sensitivity analysis including a 30 and 60 day grace period will be performed to take into account incomplete adherence to treatment and dose modifications'}, {'measure': 'Persistence between apixaban and other OAT', 'timeFrame': 'Approximately 4 years', 'description': 'Oral anticoagulant: Dabigatran, Rivaroxaban and Vitamin K antagonist'}, {'measure': 'Clinically relevant bleeding events after initiating an OAT as monotherapy', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Bleeding events requiring hospitalization in patients treated with apixaban', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Bleeding events requiring out-patient care in patients treated with apixaban', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Bleeding events requiring hospitalization in patients treated with rivaroxaban', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Bleeding events requiring out-patient care in patients treated with rivaroxaban', 'timeFrame': 'Approximately 4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anticoagulation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the characteristics of patients treated with different OATs and whether these characteristics differ between treatments.\n\nFurthermore to describe persistence to each OAT and risk of bleeding after initiating each OAT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject must be over 18 years of age, male and females are eligible', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe study population will consist of all patients in Denmark who meet the following criteria:\n\n* Adult (≥18 years) at time of anticoagulant initiation\n* Diagnosed with atrial fibrillation without recorded valvular disease\n* Initiated a new OAT during the study period (January 1, 2011 and December 31, 2014).\n* For the identification of NVAF cases, the appearance at least one hospital discharge diagnosis of AF will be searched in the databases.\n\nExclusion Criteria:\n\n* Patients with prosthetic heart valves , rheumatic mitral or aortic valve disorders, and mitral aortic stenosis will be excluded'}, 'identificationModule': {'nctId': 'NCT02591732', 'briefTitle': 'A Nationwide Registry Study of Patients With Nonvalvular Atrial Fibrillation Initiating Oral Anticoagulation Therapies In The Early Period Following Apixaban Marketing In Denmark', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Nation-wide Registry Study of Patients With Non-valvular Atrial Fibrillation Initiating Anticoagulation Therapies in the Early Period Follow Apixaban Marketing in Denmark: Patient Characteristics, Treatment Patterns, and Early Bleeding Events', 'orgStudyIdInfo': {'id': 'CV185-377'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient treated with Apixaban'}, {'label': 'Patient treated with Rivaroxaban'}, {'label': 'Patient treated with Dabigatran'}, {'label': 'Patient treated with vitamin K antagonists'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Local Institution', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}