Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT04736420
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2021-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Replication of the EINSTEIN-DVT 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'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D014859', 'term': 'Warfarin'}], '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'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-14', 'size': 2179409, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-14T15:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78605}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative hazard of venous thromboembolism', 'timeFrame': 'Through study completion or point of censoring, up to 12 months', 'description': 'Claims-based algorithm: see attached protocol for full definition'}], 'secondaryOutcomes': [{'measure': 'Relative hazard of a major bleeding event', 'timeFrame': 'Through study completion or point of censoring, up to 12 months', 'description': 'Claims-based algorithm: see attached protocol for full definition'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Thromboembolism']}, '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'], '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 warfarin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or warfarin (index date). We will restrict the analyses to patients with a diagnosis of proximal DVT without symptomatic PE.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria:\n\nPlease see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.\n\nInclusion Criteria:\n\n\\- Confirmed acute symptomatic proximal DVT without symptomatic PE\n\nExclusion Criteria:\n\n* Age ≤ 18\n* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT or PE two weeks prior to and including day of enrollment\n* Other indications for VKA than DVT and/or PE six months prior to and including day of enrollment\n* Any of the following six months prior to and including day of enrollment:\n\n * Creatine clearance \\< 30 ml/min\n * Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT\\>3 ULN\n * Bacterial endocarditis\n * Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA\n * Systolic blood pressure \\> 180 mgHg or diastolic blood pressure \\> 110 mgHg\n * Childbearing potential without proper contraceptive measures, pregnancy, or breastfeeding\n* Life expectancy \\< 3 months in the last year prior to and including day of enrollment\n* Concomitant use of strong CYP3A4 inhibitors (e.g. HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers two weeks prior to and including day of enrollment\n* Symptomatic pulmonary embolism two weeks prior to and including day of enrollment'}, 'identificationModule': {'nctId': 'NCT04736420', 'briefTitle': 'Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data', 'orgStudyIdInfo': {'id': '2018P002966-DUP-EINSTEIN-DVT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Warfarin', 'description': 'Reference group', 'interventionNames': ['Drug: Warfarin']}, {'label': 'Rivaroxaban', 'description': 'Exposure group', 'interventionNames': ['Drug: Rivaroxaban']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'description': 'Rivaroxaban dispensing claim is used as the exposure group', 'armGroupLabels': ['Rivaroxaban']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Warfarin dispensing claim is used as the reference group', 'armGroupLabels': ['Warfarin']}]}, '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': 'Assistant Professor', 'investigatorFullName': 'Shirley Vichy Wang', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}