Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-02-21 @ 8:47 PM
Study NCT ID:
NCT04169269
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2019-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized to one of two medications.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2019-11-15', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adherence to medication regimen', 'timeFrame': '2 weeks', 'description': 'measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen'}, {'measure': 'adherence to medication regimen', 'timeFrame': '6 weeks', 'description': 'measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen'}, {'measure': 'patient satisfaction with treatment regimen', 'timeFrame': '2 weeks', 'description': 'measured with Treatment Satisfaction Questionnaire for Medication (TSQM-9) instrument. TSQM-9 scores have a range of 0 to 100, with higher scores indicating higher satisfaction.'}, {'measure': 'patient satisfaction with treatment regimen', 'timeFrame': '6 weeks', 'description': 'measured with Treatment Satisfaction Questionnaire for Medication (TSQM-9) instrument. TSQM-9 scores have a range of 0 to 100, with higher scores indicating higher satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with a bleeding event', 'timeFrame': '2 weeks', 'description': 'measured through record review and participant reporting'}, {'measure': 'Number of participants with a bleeding event', 'timeFrame': '6 weeks', 'description': 'measured through record review and participant reporting'}, {'measure': 'Number of participants with a bleeding event', 'timeFrame': '3 months', 'description': 'measured through record review and participant reporting'}, {'measure': 'Number of participants with a clotting event', 'timeFrame': '2 weeks', 'description': 'measured through record review and participant reporting'}, {'measure': 'Number of participants with a clotting event', 'timeFrame': '6 weeks', 'description': 'measured through record review and participant reporting'}, {'measure': 'Number of participants with a clotting event', 'timeFrame': '3 months weeks', 'description': 'measured through record review and participant reporting'}, {'measure': 'treatment cost', 'timeFrame': '3 months', 'description': 'cost in U.S. dollars for 20 days of treatment drug'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Vein Thrombosis', 'Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '36399673', 'type': 'DERIVED', 'citation': 'John MP 2nd, Streufert BD, Downes K, Chase CB, Mir HR. A Prospective Randomized Controlled Trial Comparing Enoxaparin & Rivaroxaban for Venous Thromboembolism Prophylaxis in Orthopaedic Trauma. J Orthop Trauma. 2022 Dec 1;36(12):615-622. doi: 10.1097/BOT.0000000000002454.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare oral rivaroxaban with injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.', 'detailedDescription': 'This study is a randomized, controlled trial of orthopaedic trauma patients presenting to a single academic level one trauma center that require an extended course of venous thromboembolism event chemoprophylaxis. The goal is to compare oral rivaroxaban with our standard-of-care, injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.\n\nAll patients included in the study would be treated with the standard enoxaparin 40 milligram injection while an inpatient. Upon hospital discharge, those requiring extended venous thromboembolism event chemoprophylaxis will be randomized to receive 20 days of either self-injected enoxaparin 40 milligrams or oral rivaroxaban,10 milligrams, a non-vitamin K oral anticoagulant. Both groups will then receive our current standard of care, aspirin 81 milligrams once daily for the remaining 3 weeks, for a total of 6 weeks of venous thromboembolism event chemoprophylaxis. Routine postoperative care will be provided by the treating surgeon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Orthopaedic trauma patients deemed by the attending, treating surgeon to require an extended duration of venous thromboembolism chemoprophylaxis beyond that provided as an inpatient.\n\n * Patients being discharged directly to home.\n\nExclusion Criteria:\n\n* • Patients being discharged to a rehabilitation center or a skilled nursing facility.\n\n * A contraindication to anticoagulation such as traumatic or other hemorrhage, as determined by the treating surgeon and/or consulting services.\n * Ongoing venous thromboembolism treatment or extended prophylaxis (i.e. past history of multiple deep vein thrombosis/pulmonary embolism) for current or recent deep vein thrombosis, pulmonary embolism or other coagulopathic disorder\n * Chronic anticoagulation for atrial fibrillation or other medical disorder requiring chronic anticoagulation therapy.\n * Perceived low-risk patients requiring only aspirin or no pharmacological venous thromboembolism prophylaxis.\n * Pregnant, prisoner, under 18 years old, or do not speak English'}, 'identificationModule': {'nctId': 'NCT04169269', 'briefTitle': 'Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban', 'organization': {'class': 'NETWORK', 'fullName': 'Florida Orthopaedic Institute'}, 'officialTitle': 'Patient Adherence to Venous Thromboembolism Prophylaxis in Orthopaedic Trauma Patients: A Randomized, Controlled Trial Comparing Subcutaneous Enoxaparin & Oral Rivaroxaban', 'orgStudyIdInfo': {'id': '20192684'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin', 'description': 'enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days', 'interventionNames': ['Drug: Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rivaroxaban', 'description': 'rivaroxaban oral 10 milligram tablet daily for 20 days', 'interventionNames': ['Drug: Rivaroxaban 10 milligram Oral Tablet']}], 'interventions': [{'name': 'Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters', 'type': 'DRUG', 'otherNames': ['Lovenox'], 'description': 'anticoagulant, subcutaneous injection', 'armGroupLabels': ['Enoxaparin']}, {'name': 'Rivaroxaban 10 milligram Oral Tablet', 'type': 'DRUG', 'otherNames': ['Xarelto'], 'description': 'anticoagulant, oral', 'armGroupLabels': ['Rivaroxaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Steverson, MHA', 'role': 'CONTACT', 'email': 'bsteverson@floridaortho.com', 'phone': '813-253-2068'}, {'name': 'Randi Alexander, MPH', 'role': 'CONTACT', 'email': 'ralexander@floridaortho.com', 'phone': '8132532068'}, {'name': 'Hassan Mir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florida Orthopaedic Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Barbara Steverson, MHA', 'role': 'CONTACT', 'email': 'bsteverson@floridaortho.com', 'phone': '8132532068'}, {'name': 'Randi Alexander, MPH', 'role': 'CONTACT', 'email': 'bsteverson@floridaortho.com', 'phone': '8132532068'}], 'overallOfficials': [{'name': 'Hassan Mir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Orthopaedic Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Orthopaedic Institute', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research, Orthopaedic Trauma Service', 'investigatorFullName': 'Barbara Steverson', 'investigatorAffiliation': 'Florida Orthopaedic Institute'}}}}