Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT00332020
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2006-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
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': 'D017984', 'term': 'Enoxaparin'}], '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': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2457}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-26', 'studyFirstSubmitDate': '2006-05-30', 'studyFirstSubmitQcDate': '2006-05-30', 'lastUpdatePostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes', 'timeFrame': 'Treatment period: up to day 35+/-6'}], 'secondaryOutcomes': [{'measure': 'Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)', 'timeFrame': 'Treatment period: up to day 35+/-6'}, {'measure': 'Incidence of symptomatic VTE (DVT, PE)', 'timeFrame': 'Treatment period: up to day 35+/-6'}, {'measure': 'Incidence of DVT (total, proximal, distal)', 'timeFrame': 'Treatment period: up to day 35+/-6'}, {'measure': 'Incidence of symptomatic VTE during follow-up', 'timeFrame': 'Follow-up period: following 35+/-6 days'}, {'measure': 'The composite endpoint comprising major VTE and treatment-emergent major bleeding', 'timeFrame': 'For major VTE, treatment period: up to Day 35+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication'}, {'measure': 'Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death', 'timeFrame': 'Treatment period: up to day 35+/-6'}, {'measure': 'Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death', 'timeFrame': 'Treatment period: up to day 35+/-6'}, {'measure': 'Treatment-emergent major bleedings', 'timeFrame': 'From first dose of double-blind study medication to up to two days after last dose of double-blind study medication'}]}, 'conditionsModule': {'conditions': ['Prevention', 'Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '18582928', 'type': 'DERIVED', 'citation': 'Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008 Jul 5;372(9632):31-9. doi: 10.1016/S0140-6736(08)60880-6. Epub 2008 Jun 24.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 18 years or above\n* Patients scheduled for elective total hip replacement\n\nExclusion Criteria:\n\n* Planned, staged total bilateral hip replacement\n* Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin\n* Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin\n* Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)'}, 'identificationModule': {'nctId': 'NCT00332020', 'acronym': 'RECORD 2', 'briefTitle': 'Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement.', 'orgStudyIdInfo': {'id': '11357'}, 'secondaryIdInfos': [{'id': '2005-004691-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Rivaroxaban (BAY59-7939)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 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