Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-04-23 @ 3:51 PM
Study NCT ID:
NCT02631057
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan
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': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D014859', 'term': 'Warfarin'}], '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'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Serious and other (non-serious) adverse events were not of interest in this study and therefore were not collected or assessed as part of the study, in addition individual patient data is not available therefore adverse event data is not presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran Etexilate [Prazaxa®]', 'description': 'The patients were administered Dabigatran Etexilate 75 mg\\*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Warfarin', 'description': 'Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '899', 'groupId': 'OG000'}, {'value': '3414', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate [Prazaxa®]', 'description': 'The patients were administered Dabigatran Etexilate 75 mg\\*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '19.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.484', 'ciLowerLimit': '-3.717', 'ciUpperLimit': '-1.251', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.629', 'estimateComment': 'The ATET of LoS from oral anticoagulant initiation to hospital discharge was calculated as \\[Dabigatran - Warfarin\\] in the matched cohort of matching ratio 1:3.', 'statisticalMethod': 'Abadie-Imbens', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "LoS Average Treatment Effect on the Treated (ATET) \\[Dabigatran group\\], dispersion analysed with Abadie-Imbens's standard error."}], 'paramType': 'MEAN', 'timeFrame': 'From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.', 'description': 'The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included patients who received the treatment Dabigatran Etexilate \\[Prazaxa®\\] or Warfarin.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran Etexilate [Prazaxa®]', 'description': 'The patients were administered Dabigatran Etexilate 75 mg\\*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).'}, {'id': 'FG001', 'title': 'Warfarin', 'description': 'Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '899'}, {'groupId': 'FG001', 'numSubjects': '3414'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '899'}, {'groupId': 'FG001', 'numSubjects': '3414'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '899', 'groupId': 'BG000'}, {'value': '3414', 'groupId': 'BG001'}, {'value': '4313', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran Etexilate [Prazaxa®]', 'description': 'The patients were administered Dabigatran Etexilate 75 mg\\*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).'}, {'id': 'BG001', 'title': 'Warfarin', 'description': 'Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.2', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '76.1', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '74.9', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '1398', 'groupId': 'BG001'}, {'value': '1695', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '602', 'groupId': 'BG000'}, {'value': '2016', 'groupId': 'BG001'}, {'value': '2618', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis set included patients who received the treatment Dabigatran Etexilate \\[Prazaxa®\\] or Warfarin.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4313}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-30', 'studyFirstSubmitDate': '2015-12-08', 'resultsFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-30', 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline', 'timeFrame': 'From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.', 'description': 'The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the Length of Stay from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequently treated with dabigatran or warfarin for non-valvular atrial fibrillation in a real-world Japanese clinical practice. The secondary objective of the study is to compare LoS of patients hospitalized with 1) acute ischemic stroke, and 2) due to non-valvular atrial fibrillation. Other objectives are (1) to compare the in-hospital direct and indirect-related costs between dabigatran and warfarin, and (2) to compare the rates of patients directly discharged at home after the index hospitalization between dabigatran and warfarin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Japan', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1\\. Hospitalized patients among patients having a visit record with a confirmed diagnosis of NVAF (ICD-10 Code: I48) and prescribed dabigatran or warfarin in the hospitalization period\n\nExclusion criteria:\n\n1. Having a record with a diagnosis of atrial flutter, valvular atrial fibrillation or postoperative atrial fibrillation diagnosis as standard disease name during the study period.\n2. Having a record with a diagnosis of rheumatic atrial fibrillation (ICD-10 code I05 to I09 \\[chronic rheumatic atrial fibrillation\\])or mechanical-valvular atrial fibrillation (ICD-10 code T820 \\[artificial cardiac valve mechanical complication\\]) during the study period.\n3. Having a record with a confirmed diagnosis of cancer (ICD-10 code C00-C97 \\[malignant neoplasm\\]) during the study period.\n4. Having a record of dialysis (class J038 artificial kidney) during the study period.\n5. Having a record of dabigatran use for a purpose other than prevention of ischemic stroke and systemic embolism in non-valvular atrial fibrillation patients.\n6. Having a record of dabigatran or warfarin before the hospitalization\n7. Having a record of new diagnosis of atrial fibrillation after the initiation of dabigatran or warfarin treatment in the hospitalization period.'}, 'identificationModule': {'nctId': 'NCT02631057', 'briefTitle': 'Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Comparison of the Length of Stay in Patients Hospitalized and Initiated With Dabigatran or Warfarin for a Concomitant Non-Valvular Atrial Fibrillation in Real-world Japanese Therapeutic Practice (SHORT-J)', 'orgStudyIdInfo': {'id': '1160.254'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-Valvular Atrial Fibrillation', 'interventionNames': ['Drug: Dabigatran']}, {'label': 'acute ischemic stroke', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Dabigatran', 'type': 'DRUG', 'description': 'Dabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day', 'armGroupLabels': ['Non-Valvular Atrial Fibrillation']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Warfarin tablet (adjustment by each patients)', 'armGroupLabels': ['acute ischemic stroke']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shinagawa City', 'country': 'Japan', 'facility': '1160.254.81001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.63627, 'lon': 133.00572}}, {'zip': '1416017', 'city': 'Tokyo, Shinagawa', 'country': 'Japan', 'facility': 'NISED Center'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}