Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-26 @ 5:43 PM
Study NCT ID:
NCT03474757
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2018-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases
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': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10528}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2018-03-21', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age', 'timeFrame': 'At Baseline'}, {'measure': 'Sex', 'timeFrame': 'At Baseline'}, {'measure': 'Co-morbidity', 'timeFrame': 'At Baseline'}, {'measure': 'Healthcare utilization', 'timeFrame': 'Up to 2 years', 'description': 'Primary Care Physicians visits, Outpatient visits and Hospital admissions'}, {'measure': 'Proportion of Naive to non-naive patient', 'timeFrame': 'At Baseline'}, {'measure': 'Dose at first prescription', 'timeFrame': 'Up to 6 years'}, {'measure': 'Duration of treatment', 'timeFrame': 'Up to 6 years'}, {'measure': 'Discontinuation', 'timeFrame': 'Up to 6 years'}, {'measure': 'Switch to another study drug', 'timeFrame': 'Up to 6 years'}], 'secondaryOutcomes': [{'measure': 'Time trends of usage of study medications', 'timeFrame': 'Up to 6 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217261&parentIdentifier=20104&attachmentIdentifier=56598450-2870-4624-96d2-d9e0bbaf1111&fileName=20104_study_synopsis_revised_2020-03-25.pdf&versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This population-based descriptive study will characterize first-time users of three NOACs (rivaroxaban, dabigatran and apixaban) in prevention of stroke in non-valvular atrial fibrillation (SPAF) patients and will assess the patterns of drug utilization in routine general practice in Colombia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Using the population from the Audifarma database, the study will be comprised of three separate cohorts of first time users of rivaroxaban, dabigatran and apixaban using the first prescription date (index date) of the respective drug (index drug). All patients aged ≥18 years with at least one year of enrollment in the databases and one year since first encounter with healthcare provider will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First prescription of NOACs (rivaroxaban, dabigatran and apixaban) in the outpatient setting.\n* Non valvular Atrial Fibrillation (NVAF) Patients\n* aged ≥18 years\n* at least one year of enrollment in the Audifarma database\n* one year since first encounter with healthcare provider will be included in the study\n\nExclusion Criteria:\n\n* Patients with any record of index drug prescription prior to the enrolment period.\n* Patients who qualify as members of more than one cohort study on the same day'}, 'identificationModule': {'nctId': 'NCT03474757', 'acronym': 'TREND', 'briefTitle': 'Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases - TREND Colombia', 'orgStudyIdInfo': {'id': '20104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SPAF patients in Colombia_Rivaroxaban', 'description': 'First time users of rivaroxaban in the Audifarma database', 'interventionNames': ['Other: Data Collection']}, {'label': 'SPAF patients in Colombia_Dabigatran', 'description': 'First time users of dabigatran in the Audifarma database', 'interventionNames': ['Other: Data Collection']}, {'label': 'SPAF patients in Colombia_Apixaban', 'description': 'First time users of apixaban in the Audifarma database', 'interventionNames': ['Other: Data Collection']}], 'interventions': [{'name': 'Data Collection', 'type': 'OTHER', 'description': 'Data will be extracted from July 2009 to the last available database extraction', 'armGroupLabels': ['SPAF patients in Colombia_Apixaban', 'SPAF patients in Colombia_Dabigatran', 'SPAF patients in Colombia_Rivaroxaban']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Colombia', 'facility': 'Many Locations'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}