Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-27 @ 1:23 PM
Study NCT ID:
NCT05264168
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2022-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'C522181', 'term': 'apixaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-11', 'size': 3192634, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-11T14:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41875}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2022-02-22', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative hazard of major bleeding or clinically relevant non-major bleeding events', 'timeFrame': 'Through study completion or censoring, up to 90 days', 'description': 'Claims-based algorithm: relative hazard of major bleeding or clinically relevant non-major bleeding events'}], 'secondaryOutcomes': [{'measure': 'Relative hazard of major bleeding', 'timeFrame': 'Through study completion or censoring, up to 90 days', 'description': 'Claims-based algorithm: relative hazard of major bleeding'}, {'measure': 'Relative hazard of clinically relevant non-major bleeding', 'timeFrame': 'Through study completion or censoring, up to 90 days', 'description': 'Claims-based algorithm: relative hazard of clinically relevant non-major bleeding'}, {'measure': 'Relative hazard of all-cause mortality', 'timeFrame': 'Through study completion, up to 90 days', 'description': 'Claims-based algorithm: relative hazard of all-cause mortality'}, {'measure': 'Relative hazard of recurrent VTE', 'timeFrame': 'Through study completion, up to 90 days', 'description': 'Claims-based algorithm: relative hazard of recurrent VTE'}, {'measure': 'Relative hazard of extracranial bleeding', 'timeFrame': 'Through study completion, up to 90 days', 'description': 'Claims-based algorithm: relative hazard of extracranial bleeding'}, {'measure': 'Relative hazard of intracranial bleeding', 'timeFrame': 'Through study completion, up to 90 days', 'description': 'Claims-based algorithm: relative hazard of intracranial bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Thromboembolism', 'Pulmonary Embolism', 'DVT']}, 'descriptionModule': {'briefSummary': "Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.", 'detailedDescription': "This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing rivaroxaban to apixaban users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or apixaban (index date). Analysis is restricted to patients hospitalized with a VTE.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalization for PE or Proximal DVT \\[Day -14, Day 0\\]\n* At least 18 years of age\n\nExclusion Criteria:\n\n* Prior use of a DOAC or warfarin \\[Day -180, Day 0\\]\n* Stage 4 or 5 chronic kidney disease or end-stage renal disease \\[Day -180, Day 0\\]\n* Dialysis or renal transplant \\[Day -180, Day 0\\]\n* Recent major or clinically relevant non-major bleeding \\[Day -180, Day 0\\]\n* Cancer \\[Day -180, Day 0\\]\n* Bypass surgery, obesity, or the use of a weight loss or appetite suppressor \\[Day -180, Day 0\\]\n* Significant liver disease and coagulopathy \\[Day -180, Day 0\\]\n* Use of CYP3A4 or P-gp inhibitors or inducers \\[Day -180, Day 0\\]\n* Other indications for anticoagulation (atrial fibrillation or prosthetic heart valve) \\[Day -180, Day 0\\]\n* Pregnancy or breastfeeding \\[Day -180, Day 0\\]\n* Use of an antiplatelet \\[Day -180, Day 0\\]'}, 'identificationModule': {'nctId': 'NCT05264168', 'briefTitle': 'Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data', 'orgStudyIdInfo': {'id': '2018P002966-DUP-COBRRA-VT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rivaroxaban', 'description': 'Reference group', 'interventionNames': ['Drug: Rivaroxaban']}, {'label': 'Apixaban', 'description': 'Exposure group', 'interventionNames': ['Drug: Apixaban']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'otherNames': ['Xarelto'], 'description': 'Any rivaroxaban dispensing claim is used as the reference group', 'armGroupLabels': ['Rivaroxaban']}, {'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['Eliquis'], 'description': 'Any apixaban dispensing claim is used as the exposure group', 'armGroupLabels': ['Apixaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Shirley Wang, PhD, ScM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shirley Vichy Wang', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}