Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05471505
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2022-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding
Sponsor:
Organization:
Raw JSON
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Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Not applicable as safety data was not planned to be collected during the study', 'description': 'This study involved data that existed as structured data by the time of study start. In these data sources, individual participants data was not retrieved or validated, and it was not possible to link (i.e., identify a potential association between) a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event (AE) (i.e., identifiable patient, identifiable reporter, a suspect product, and event) could not be met.', 'eventGroups': [{'id': 'EG000', 'title': 'Apixaban', 'description': 'Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. 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IPTW method was applied to balance the participants' characteristics."}], 'classes': [{'categories': [{'measurements': [{'value': '49.038', 'groupId': 'OG000', 'lowerLimit': '47.317', 'upperLimit': '50.823'}, {'value': '48.917', 'groupId': 'OG001', 'lowerLimit': '47.071', 'upperLimit': '50.835'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.909', 'ciLowerLimit': '0.862', 'ciUpperLimit': '0.958', 'statisticalMethod': 'COX Proportional Hazards Regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study', 'description': 'Incidence rate per 1000 participant-years for the first occurrence of ischemic stroke event after index date was reported. Ischemic stroke after index date not including the index date was identified using hospital claims which had an ischemic stroke diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.', 'unitOfMeasure': 'Events Per 1000 Participant-Years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. 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Extracted data was evaluated for objectives of this study in approximately 1 month of this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72095', 'groupId': 'BG000'}, {'value': '48627', 'groupId': 'BG001'}, {'value': '120722', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Apixaban', 'description': 'Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively.'}, {'id': 'BG001', 'title': 'Warfarin', 'description': 'Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72095', 'groupId': 'BG000'}, {'value': '48627', 'groupId': 'BG001'}, {'value': '120722', 'groupId': 'BG002'}]}], 'categories': [{'title': '<= 64 years', 'measurements': [{'value': '4471', 'groupId': 'BG000'}, {'value': '4030', 'groupId': 'BG001'}, {'value': '8501', 'groupId': 'BG002'}]}, {'title': '65-69 years', 'measurements': [{'value': '4978', 'groupId': 'BG000'}, {'value': '3855', 'groupId': 'BG001'}, {'value': '8833', 'groupId': 'BG002'}]}, {'title': '70-79 years', 'measurements': [{'value': '20621', 'groupId': 'BG000'}, {'value': '14749', 'groupId': 'BG001'}, {'value': '35370', 'groupId': 'BG002'}]}, {'title': '80-89 years', 'measurements': [{'value': '33567', 'groupId': 'BG000'}, {'value': '20677', 'groupId': 'BG001'}, {'value': '54244', 'groupId': 'BG002'}]}, {'title': '=>90 years', 'measurements': [{'value': '8458', 'groupId': 'BG000'}, {'value': '5316', 'groupId': 'BG001'}, {'value': '13774', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72095', 'groupId': 'BG000'}, {'value': '48627', 'groupId': 'BG001'}, {'value': '120722', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '31786', 'groupId': 'BG000'}, {'value': '19856', 'groupId': 'BG001'}, {'value': '51642', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40309', 'groupId': 'BG000'}, {'value': '28771', 'groupId': 'BG001'}, {'value': '69080', 'groupId': 'BG002'}]}]}], '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'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All eligible participants whose data were extracted from database and observed in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-01', 'size': 1915266, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-21T13:40', 'hasProtocol': True}, {'date': '2022-06-29', 'size': 543872, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-21T13:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120722}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2022-06-28', 'resultsFirstSubmitDate': '2023-09-21', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-17', 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate Per 1000 Participant-Years For First Occurrence of Composite Stroke and Systemic Embolism (SE) Events After Index Date: Balanced Cohorts', 'timeFrame': 'Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study', 'description': 'Incidence rate per 1000 participant-years for the first occurrence of composite stroke and SE events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (excluding non-traumatic extradural hemorrhage). Stroke after index date not including the index date was identified using hospital claims which had a stroke diagnosis code as the first listed International Classification of Diseases 10th Revision (ICD-10) diagnosis code. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.'}, {'measure': 'Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Bleeding Event After Index Date: Balanced Cohorts', 'timeFrame': 'Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study', 'description': 'Incidence rate per 1000 participant-years for the first occurrence of major bleeding event after index date was reported. Major bleeding was defined as any bleeding that required hospitalization for treatment. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Incidence Rate Per 1000 Participant-Years For First Occurrence of Ischemic Stroke Event After Index Date: Balanced Cohorts', 'timeFrame': 'Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study', 'description': 'Incidence rate per 1000 participant-years for the first occurrence of ischemic stroke event after index date was reported. Ischemic stroke after index date not including the index date was identified using hospital claims which had an ischemic stroke diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.'}, {'measure': 'Incidence Rate Per 1000 Participant-Years For First Occurrence of Hemorrhagic Stroke Event After Index Date: Balanced Cohorts', 'timeFrame': 'Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study', 'description': 'Incidence rate per 1000 participant-years for the first occurrence of hemorrhagic stroke event after index date was reported. Hemorrhagic stroke after index date not including the index date was identified using hospital claims which had a hemorrhagic stroke diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.'}, {'measure': 'Incidence Rate Per 1000 Participant-Years For First Occurrence of Systemic Embolism (SE) Event After Index Date: Balanced Cohorts', 'timeFrame': 'Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study', 'description': 'Incidence rate per 1000 participant-years for the first occurrence of SE event after index date was reported. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.'}, {'measure': 'Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Intracranial Bleeding Event After Index Date: Balanced Cohorts', 'timeFrame': 'Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study', 'description': 'Incidence rate per 1000 participant-years for the first occurrence of major intracranial bleeding event after index date was reported. Major intracranial bleeding after index date was identified using hospital claims which had an intracranial bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.'}, {'measure': 'Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Gastrointestinal (GI) Bleeding Event After Index Date: Balanced Cohorts', 'timeFrame': 'Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study', 'description': 'Incidence rate per 1000 participant-years for the first occurrence of major GI bleeding event after index date was reported. Any GI bleeding after index date was identified using hospital claims which had a GI bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.'}]}, 'conditionsModule': {'conditions': ['Non-valvular Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B0661178', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '* The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database.\n* Atrial fibrillation (AF) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots.\n* An anticoagulation therapy is a critical treatment to prevent thromboembolism in NVAF patients.\n* Apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF in Phase 3 clinical trial.\n* Previously we have shown that bleeding risks as well as stroke/SE risks are less in real world clinical practice in Japan compared to warfarin. However there are limited apixaban data for Japanese NVAF patients with high bleeding risk(s).\n* This study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in Japanese patients with NVAF who has higher chance of bleeding'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study uses data from the MDV database, which includes the data used for both inpatient and outpatient insurance claims by hospitals according to the Diagnosis Procedure Combination (DPC) procedure.\n\nThe study population will consist of adults with NVAF who are newly prescribed apixaban or warfarin.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with atrial fibrillation (AF) anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.\n* Prescribed apixaban or warfarin on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort\n* No use of the any oral anticoagulants (OACs) during the baseline period (the 180 days before the index date)\n* Age of 18 years or older on the index date\n\nExclusion Criteria:\n\n* Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period\n* Having a procedure of prosthetic heart valve during the baseline period\n* Having a cardiac surgery procedure record during the baseline period\n* Having a diagnosis of venous thromboembolism during the baseline period\n* Having a hemodialysis during the baseline period\n* Female patients with pregnancy during the baseline and follow-up period\n* Patients prescribed apixaban other than approved daily dose (\\<5 mg or \\>10 mg)\n* Patients prescribed OACs during baseline period"}, 'identificationModule': {'nctId': 'NCT05471505', 'briefTitle': 'Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Safety and Effectiveness of Apixaban Compared to Warfarin in NVAF Patients at Higher Risk of Bleeding.', 'orgStudyIdInfo': {'id': 'B0661178'}}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}