Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-03-04 @ 7:35 AM
Study NCT ID:
NCT02687867
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2016-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'C008208', 'term': 'acarboxyprothrombin'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56039}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-02-17', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Hospitalization Events (composite endpoint)', 'timeFrame': 'Within 2 years of starting treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-valvular atrial fibrillation (NVAF)', 'Prevention', 'Stroke'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'To obtain a better understanding on the comparative effectiveness of dabigatran versus Vitamin K antagonist (VKA) for stroke prevention in patients with Non-valvular atrial fibrillation (NVAF) in a real-life setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-valvular atrial fibrillation (NVAF).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-valvular atrial fibrillation will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 (International Classification of Disease, Ninth Revision, Clinical Modification) as the diagnosis code at any time in the patient's data history prior to inclusion\n* Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics\n* CHA2DS2-Vasc (Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category ) score ≥2 during the 180 days prior to index dabigatran use baseline period\n\nExclusion Criteria:\n\n* Patients \\<18 years of age\n* Patients with valvular Atrial fibrillation\n* Pregnancy\n* Malignant cancers\n* Transient cause of Atrial fibrillation\n* Patients with Venous thromboembolism (pulmonary embolism or Deep Vein Thrombosis)\n* Patients with major surgery defined as hip or knee replacement\n* Prescriptions of Oral anticoagulants (OACs) {apixaban, warfarin, dabigatran, rivaroxaban} before index date\n* Prescription of more than one OAC on the index date\n* Patient with any of the events defined in the composite endpoint"}, 'identificationModule': {'nctId': 'NCT02687867', 'acronym': 'DABI-F', 'briefTitle': 'Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Real-world Comparative Effectiveness of Dabigatran Versus VKA', 'orgStudyIdInfo': {'id': '18732'}, 'secondaryIdInfos': [{'id': 'NN1513US', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dabigatran', 'description': 'Non-valvular atrial fibrillation patients who were initiated on dabigatran for stroke prevention.', 'interventionNames': ['Drug: Dabigatran (Pradaxa)']}, {'label': 'Vitamin K antagonist', 'description': 'Non-valvular atrial fibrillation patients who were initiated on VKA for stroke prevention.', 'interventionNames': ['Drug: Vitamin K antagonist']}], 'interventions': [{'name': 'Dabigatran (Pradaxa)', 'type': 'DRUG', 'description': 'As prescribed by treating physicians', 'armGroupLabels': ['Dabigatran']}, {'name': 'Vitamin K antagonist', 'type': 'DRUG', 'otherNames': ['As prescribed by treating physicians'], 'description': 'As prescribed by treating physicians', 'armGroupLabels': ['Vitamin K antagonist']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}