Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-08 @ 1:26 PM
Study NCT ID:
NCT03254134
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2017-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness and Safety Between Warfarin and Dabigatran
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D014859', 'term': 'Warfarin'}, {'id': 'D000069604', 'term': 'Dabigatran'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'This is a cohort study using based on existing data; therefore, it is not feasible to make a causality assessment at the individual case level.', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran', 'description': 'Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Warfarin', 'description': 'Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Stroke and Systemic Embolism (SE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4606', 'groupId': 'OG000'}, {'value': '4606', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.898', 'groupId': 'OG000'}, {'value': '3.563', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.720', 'ciLowerLimit': '0.534', 'ciUpperLimit': '0.970', 'groupDescription': 'There was no formal hypothesis testing.', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'The hazard ratio of stroke for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable'}], 'paramType': 'NUMBER', 'timeFrame': 'From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.', 'description': 'Incidence rate of stroke and systemic embolism (SE).', 'unitOfMeasure': 'per patient-year', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4606', 'groupId': 'OG000'}, {'value': '4606', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.639', 'groupId': 'OG000'}, {'value': '1.128', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.549', 'ciLowerLimit': '0.303', 'ciUpperLimit': '0.994', 'groupDescription': 'There was no formal hypothesis testing.', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'The hazard ratio of systemic embolism for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable'}], 'paramType': 'NUMBER', 'timeFrame': 'From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.', 'description': 'Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.', 'unitOfMeasure': 'per patient-year', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran', 'description': 'Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.'}, {'id': 'FG001', 'title': 'Warfarin', 'description': 'Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5745'}, {'groupId': 'FG001', 'numSubjects': '16745'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5146'}, {'groupId': 'FG001', 'numSubjects': '13115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '599'}, {'groupId': 'FG001', 'numSubjects': '3630'}]}], 'dropWithdraws': [{'type': 'Not eligible patients', 'reasons': [{'groupId': 'FG000', 'numSubjects': '599'}, {'groupId': 'FG001', 'numSubjects': '3630'}]}]}], 'recruitmentDetails': 'A non-interventional study based on existing health insurance claims data. 5,146 and 13,115 patients were prescribed dabigatran and warfarin.', 'preAssignmentDetails': 'The Japanese patients diagnosed as Non-Valvular Atrial Fibrillation (NVAF) and newly treated with dabigatran and warfarin in the real world Japanese setting between April 2010 and June 2016 using the Medical Data Vision (MDV) database.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5146', 'groupId': 'BG000'}, {'value': '13115', 'groupId': 'BG001'}, {'value': '18261', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran', 'description': 'Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.'}, {'id': 'BG001', 'title': 'Warfarin', 'description': 'Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5146', 'groupId': 'BG000'}, {'value': '13115', 'groupId': 'BG001'}, {'value': '18261', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72', 'spread': '10', 'groupId': 'BG000'}, {'value': '78', 'spread': '10', 'groupId': 'BG001'}, {'value': '76', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Eligible patients who were prescribed dabigatran and warfarin as the first OACs'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5146', 'groupId': 'BG000'}, {'value': '13115', 'groupId': 'BG001'}, {'value': '18261', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1695', 'groupId': 'BG000'}, {'value': '5294', 'groupId': 'BG001'}, {'value': '6989', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3451', 'groupId': 'BG000'}, {'value': '7821', 'groupId': 'BG001'}, {'value': '11272', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Eligible patients who were prescribed dabigatran and warfarin as the first OACs'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Eligible patients who were prescribed dabigatran and warfarin as the first OACs'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-06', 'size': 437735, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-22T07:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22490}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-04', 'studyFirstSubmitDate': '2017-08-17', 'resultsFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2017-08-17', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-04', 'studyFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Stroke and Systemic Embolism (SE)', 'timeFrame': 'From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.', 'description': 'Incidence rate of stroke and systemic embolism (SE).'}], 'secondaryOutcomes': [{'measure': 'Incidence Rate of Major Bleeding', 'timeFrame': 'From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.', 'description': 'Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.', 'detailedDescription': 'This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patients with atrial fibrillation contained in the Medical Data Vision (MDVI) database which is a Japanese, nationwide claims data containing approximately 16 million patients cumulatively. The data cut is between March 2011 to June 2016, and the patients in the MDV database are those who have visited DPC hospitals (diagnostic procedure combination, a lump-sum payment system based on disease diagnosis to be treated similar to Medicare/Medicaid in the USA) hospitals which provide acute in-patient, as well as outpatient care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged \\>18 year-old with confirmed diagnosis of Non-Valvular Atrial Fibrillation (NVAF) (ICD 10 code I48)\n* having a first prescription (index date) of either dabigatran or warfarin between 14 March 2011 to 30 June 2016\n* having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the index date (this period is defined as the baseline period)\n\nExclusion Criteria:\n\n* patients having less than 12 months of enrolment prior to the index date\n* being dialysis or kidney transplant recipients in baseline period\n* having either atrial flutter, valvular atrial fibrillation (AF)\n* mechanical valve placement, rheumatic AF\n* and/or mitral valve prolapse/regurge/stenosis in baseline period\n* having record of deep vein thrombosis or pulmonary embolism \\< 6 months before AF diagnosis in baseline period'}, 'identificationModule': {'nctId': 'NCT03254134', 'briefTitle': 'Comparative Effectiveness and Safety Between Warfarin and Dabigatran', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients', 'orgStudyIdInfo': {'id': '1160-0288'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial Fibrillation', 'description': 'patients with atrial fibrillation', 'interventionNames': ['Drug: Warfarin', 'Drug: Dabigatran']}], 'interventions': [{'name': 'Warfarin', 'type': 'DRUG', 'description': 'patients treated with warfarin', 'armGroupLabels': ['Atrial Fibrillation']}, {'name': 'Dabigatran', 'type': 'DRUG', 'otherNames': ['PRADAXA'], 'description': 'patients treated with Dabigatran', 'armGroupLabels': ['Atrial Fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Nippon Boehringer Ingelheim Co., Ltd.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}