Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT05051904
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Based on Japanese Medical Records That Looks at Bleeding Events in People With Atrial Fibrillation and Coronary Artery Disease Who Start Taking Either Dabigatran, Rivaroxaban, or Warfarin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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}, 'limitationsAndCaveats': {'description': 'This was a Non interventional study (NIS) based on existing data. Therefore, the study might be subject to potential residual confounding due to the absence of certain key data.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was not applicable for this study.', 'description': 'As this is a non-interventional study with secondary use of data, safety reporting on an individual case level is not applicable. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not collected in the database. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed".', 'eventGroups': [{'id': 'EG000', 'title': 'Warfarin', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dabigatran', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Rivaroxaban', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Fatal or Non-fatal Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6682', 'groupId': 'OG000'}, {'value': '12231', 'groupId': 'OG001'}, {'value': '20422', 'groupId': 'OG002'}, {'value': '12231', 'groupId': 'OG003'}, {'value': '6682', 'groupId': 'OG004'}, {'value': '20422', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran - Matched With Warfarin Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG001', 'title': 'Warfarin - Matched With Dabigatran Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG002', 'title': 'Rivaroxaban - Matched With Warfarin Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG003', 'title': 'Warfarin - Matched With Rivaroxaban Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG004', 'title': 'Dabigatran - Matched With Rivaroxaban Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG005', 'title': 'Rivaroxaban - Matched With Dabigatran Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection)'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '31'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '57'}, {'value': '41', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '44'}, {'value': '52', 'groupId': 'OG003', 'lowerLimit': '47', 'upperLimit': '57'}, {'value': '26', 'groupId': 'OG004', 'lowerLimit': '22', 'upperLimit': '31'}, {'value': '41', 'groupId': 'OG005', 'lowerLimit': '38', 'upperLimit': '44'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.402', 'ciUpperLimit': '0.622', 'estimateComment': 'Hazard ratio \\<1 favors Dabigatran.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios."}, {'pValue': '0.0004', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.784', 'ciLowerLimit': '0.686', 'ciUpperLimit': '0.896', 'estimateComment': 'Hazard ratio \\<1 favors Rivaroxaban.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios."}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.637', 'ciLowerLimit': '0.514', 'ciUpperLimit': '0.791', 'estimateComment': 'Hazard ratio \\<1 favors Dabigatran.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios."}], 'paramType': 'NUMBER', 'timeFrame': 'From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.', 'description': 'Incidence rate of fatal or non-fatal major bleeding per number of person-years, defined as any blood transfusion and/or any hospitalization with associated bleeding in all three patient groups. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000\\*person-years)).', 'unitOfMeasure': 'Events per 1,000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched cohort of initiators of Dabigatran, Warfarin, Rivaroxaban using the inverse probability of treatment weighting (IPTW) method, identified from the Japan Medical Data Vision Co. Ltd. (MDV) database on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Composite Outcome of Stroke/SE/MI/All-cause Mortality (Inpatient) /Major Bleeding/Major GI Bleeding/ICH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6682', 'groupId': 'OG000'}, {'value': '12231', 'groupId': 'OG001'}, {'value': '20422', 'groupId': 'OG002'}, {'value': '12231', 'groupId': 'OG003'}, {'value': '6682', 'groupId': 'OG004'}, {'value': '20422', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran - Matched With Warfarin Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG001', 'title': 'Warfarin - Matched With Dabigatran Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG002', 'title': 'Rivaroxaban - Matched With Warfarin Using the s-IPTW Method', 'description': 'Rivaroxaban - matched with Warfarin using the s-IPTW method Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG003', 'title': 'Warfarin - Matched With Rivaroxaban Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG004', 'title': 'Dabigatran - Matched With Rivaroxaban Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'OG005', 'title': 'Rivaroxaban - Matched With Dabigatran Using the s-IPTW Method', 'description': 'Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection)'}], 'classes': [{'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000', 'lowerLimit': '200', 'upperLimit': '228'}, {'value': '275', 'groupId': 'OG001', 'lowerLimit': '264', 'upperLimit': '288'}, {'value': '228', 'groupId': 'OG002', 'lowerLimit': '220', 'upperLimit': '237'}, {'value': '275', 'groupId': 'OG003', 'lowerLimit': '264', 'upperLimit': '288'}, {'value': '213', 'groupId': 'OG004', 'lowerLimit': '200', 'upperLimit': '228'}, {'value': '228', 'groupId': 'OG005', 'lowerLimit': '220', 'upperLimit': '237'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.714', 'ciUpperLimit': '0.851', 'estimateComment': 'Hazard ratio \\<1 favors Dabigatran.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios."}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.827', 'ciLowerLimit': '0.777', 'ciUpperLimit': '0.88', 'estimateComment': 'Hazard ratio\\<1 favors Rivaroxaban', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios."}], 'paramType': 'NUMBER', 'timeFrame': 'From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.', 'description': 'Incidence rate of the Composite outcome of stroke/SE/MI/all-cause mortality (inpatient) /major bleeding/major GI bleeding (hospitalization due to gastrointestinal bleeding)/ICH (Intracraneal hemorrhage) per number of person-years. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000\\*person-years)). The propensity scores were estimated using the multivariable logistic regression model. Statistical analysis for comparisons: Dabigatran-Warfarin, and Rivaroxaban-Warfarin are presented as per protocol.', 'unitOfMeasure': 'Events per 1,000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched cohort of initiators of Dabigatran, Warfarin, Rivaroxaban using the inverse probability of treatment weighting (IPTW) method, identified from the Japan Medical Data Vision Co. Ltd. (MDV) database on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Warfarin', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'FG001', 'title': 'Dabigatran', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'FG002', 'title': 'Rivaroxaban', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12316'}, {'groupId': 'FG001', 'numSubjects': '6712'}, {'groupId': 'FG002', 'numSubjects': '20329'}]}, {'type': 'Crude', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12316'}, {'groupId': 'FG001', 'numSubjects': '6712'}, {'groupId': 'FG002', 'numSubjects': '20329'}]}, {'type': 's-IPTW Adjusted', 'comment': 'Balanced to account for potential confounding effects through an inverse probability of treatment weighting (IPTW) method', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12231'}, {'groupId': 'FG001', 'numSubjects': '6682'}, {'groupId': 'FG002', 'numSubjects': '20422'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12316'}, {'groupId': 'FG001', 'numSubjects': '6712'}, {'groupId': 'FG002', 'numSubjects': '20329'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A Real world, non-interventional cohort study based on existing data from The Medical Data Vision Co. Ltd. (Tokyo, Japan). The study aimed to make safety and effectiveness comparisons between warfarin, dabigatran, and rivaroxaban in routine clinical practice among Japanese non-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD).', 'preAssignmentDetails': 'Every patient who fulfilled inclusion and exclusion criteria and agreed to participate in the study was selected until the required sample size was achieved.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12316', 'groupId': 'BG000'}, {'value': '6712', 'groupId': 'BG001'}, {'value': '20329', 'groupId': 'BG002'}, {'value': '39357', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Warfarin', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'BG001', 'title': 'Dabigatran', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'BG002', 'title': 'Rivaroxaban', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12316', 'groupId': 'BG000'}, {'value': '6712', 'groupId': 'BG001'}, {'value': '20329', 'groupId': 'BG002'}, {'value': '39357', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '77.0', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '71.8', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '74.2', 'spread': '10.6', 'groupId': 'BG002'}, {'value': '74.7', 'spread': '10.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12316', 'groupId': 'BG000'}, {'value': '6712', 'groupId': 'BG001'}, {'value': '20329', 'groupId': 'BG002'}, {'value': '39357', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4448', 'groupId': 'BG000'}, {'value': '1820', 'groupId': 'BG001'}, {'value': '6411', 'groupId': 'BG002'}, {'value': '12679', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7868', 'groupId': 'BG000'}, {'value': '4892', 'groupId': 'BG001'}, {'value': '13918', 'groupId': 'BG002'}, {'value': '26678', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All Eligible: patients fulfilling all inclusion criteria and no exclusion criteria (Crude)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-15', 'size': 2190512, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-12T10:11', 'hasProtocol': True}, {'date': '2021-02-03', 'size': 448812, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-12T10:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39357}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2021-09-15', 'resultsFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2021-09-15', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-26', 'studyFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Fatal or Non-fatal Major Bleeding', 'timeFrame': 'From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.', 'description': 'Incidence rate of fatal or non-fatal major bleeding per number of person-years, defined as any blood transfusion and/or any hospitalization with associated bleeding in all three patient groups. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000\\*person-years)).'}], 'secondaryOutcomes': [{'measure': 'Incidence Rate of Composite Outcome of Stroke/SE/MI/All-cause Mortality (Inpatient) /Major Bleeding/Major GI Bleeding/ICH', 'timeFrame': 'From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.', 'description': 'Incidence rate of the Composite outcome of stroke/SE/MI/all-cause mortality (inpatient) /major bleeding/major GI bleeding (hospitalization due to gastrointestinal bleeding)/ICH (Intracraneal hemorrhage) per number of person-years. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000\\*person-years)). The propensity scores were estimated using the multivariable logistic regression model. Statistical analysis for comparisons: Dabigatran-Warfarin, and Rivaroxaban-Warfarin are presented as per protocol.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '38020057', 'type': 'DERIVED', 'citation': 'Chen Y, Gong X, Bao H. Real-world clinical outcomes of oral anticoagulants among Japanese patients with atrial fibrillation and concomitant coronary artery disease. Int J Cardiol Heart Vasc. 2023 Nov 2;49:101285. doi: 10.1016/j.ijcha.2023.101285. eCollection 2023 Dec.'}], 'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the safety and effectiveness comparisons between warfarin, dabigatran, and rivaroxaban in routine clinical practice among Japanese non-valvular atrial fibrillation (NVAF) patients with concomitant coronary artery disease (CAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Japanese patients with non-valvular atrial fibrillation and concomitant coronary artery disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-≥18 years of age\n\n* Has one year of look-back period prior to the index date (defined as the first date of prescription for dabigatran, rivaroxaban, or warfarin during the study period)\n* New users of warfarin, dabigatran, and rivaroxaban, defined as patients without historic use of any oral anticoagulants during the look-back period\n* Has at least 1 diagnosis of NVAF during the look-back period prior to or on the index date\n* Has at least 1 diagnosis of CAD during the look-back period prior to or on the index date\n\nExclusion Criteria:\n\n* Diagnosed with end-stage renal disease, or undergo hemodialysis, or experience pregnancy during the study period\n* Initiate warfarin, dabigatran, rivaroxaban due to valvular Atrial Fibrillation (AF), AF associated with mechanical valve malfunction or mechanical complication of heart valve prosthesis, or rheumatic AF\n* Underwent joint replacement procedures or diagnosed with venous thromboembolism during the look-back period prior to or on the index date\n* Prescribed with more than 1 oral anticoagulation (OAC) on the index date\n* Prescribed with more than 2 anti-platelet drugs per prescription (triple or quadruple anti-platelet use), or prescribed with any anti-platelet injection\n* Patients with missing or ambiguous age or sex information'}, 'identificationModule': {'nctId': 'NCT05051904', 'briefTitle': 'A Study Based on Japanese Medical Records That Looks at Bleeding Events in People With Atrial Fibrillation and Coronary Artery Disease Who Start Taking Either Dabigatran, Rivaroxaban, or Warfarin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Comparative Safety and Effectiveness of Warfarin, Dabigatran, and Rivaroxaban Among Japanese Patients With Non-valvular Atrial Fibrillation (NVAF) and Concomitant Coronary Artery Disease (CAD)', 'orgStudyIdInfo': {'id': '1160-0308'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Warfarin', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'label': 'Dabigatran', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}, {'label': 'Rivaroxaban', 'description': 'All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size.\n\nThe study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55216', 'city': 'Ingelheim', 'country': 'Germany', 'facility': 'Boehringer Ingelheim - International GmbH', 'geoPoint': {'lat': 49.97078, 'lon': 8.05883}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}