Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-02 @ 2:35 AM
Study NCT ID:
NCT03522259
Status:
COMPLETED
Last Update Posted:
2024-11-13
First Post:
2018-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery
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': 'D013607', 'term': 'Tablets'}], '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': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-11', 'studyFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with symptomatic or asymptomatic VTE', 'timeFrame': '28 days', 'description': 'Assessed by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Number of patients with symptomatic VTE within 28 days after bariatric surgery', 'timeFrame': '28 days', 'description': 'Assessed by ultrasound'}, {'measure': 'Number of patients with asymptomatic VTE within 28 days after bariatric surgery', 'timeFrame': '28 days', 'description': 'Assessed by ultrasound'}, {'measure': 'All cause mortality within 28 days after bariatric surgery', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rivaroxaban', 'Thromboembolic prophylaxis', 'Venous thromboembolism'], 'conditions': ['Bariatric Surgery']}, 'referencesModule': {'references': [{'pmid': '37227726', 'type': 'DERIVED', 'citation': 'Kroll D, Nett PC, Rommers N, Borbely Y, Deichsel F, Nocito A, Zehetner J, Kessler U, Fringeli Y, Alberio L, Candinas D, Stirnimann G. Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315241. doi: 10.1001/jamanetworkopen.2023.15241.'}, {'pmid': '36413425', 'type': 'DERIVED', 'citation': 'Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery.\n\nThe objectives are to assess the safety and feasibility of venous thromboembolism (VTE) prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. After bariatric surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days.\n\nAll clinically thromboembolic events will be assessed by ultrasound or CT, respectively, as soon as apparent. In addition, patients are screened for VTE at day 28 by ultrasound to detect clinically inapparent thromboses.\n\nIn a subgroup of study patients (patients from the University Hospital Inselspital, Bern) PK/PD parameters are assessed following the last intake of rivaroxaban at day 28.', 'detailedDescription': 'The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery.\n\nRivaroxaban as an oral anticoagulant could be an attractive option for thromboprophylaxis compared to subcutaneous standard treatment after bariatric surgery. Especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable.\n\nThe objectives are to assess the safety and feasibility of VTE prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. Especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable.\n\nAfter bariatric surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days.\n\nIn a subgroup of study patients (patients from the University Hospital Inselspital, Bern) PK/PD parameters are assessed following the last intake of rivaroxaban at day 28.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with scheduled elective bariatric surgery or redo surgery after bariatric interventions\n* Written informed consent\n\nExclusion Criteria:\n\n* DVT and/or PE in the patient history\n* Myocardial infarction, transient ischemic attack or stroke within 6 months of study entry\n* Uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT03522259', 'acronym': 'BARIVA', 'briefTitle': 'Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery', 'orgStudyIdInfo': {'id': 'UVCMBS003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A: Rivaroxaban short arm', 'description': '7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o.', 'interventionNames': ['Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B: Rivaroxaban long arm', 'description': '28 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o.\n\nSubgroup: PK/PD parameters are assessed following the last intake of Rivaroxaban at day 28', 'interventionNames': ['Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]']}], 'interventions': [{'name': 'Rivaroxaban 10 MG Oral Tablet [Xarelto]', 'type': 'DRUG', 'description': 'Rivaroxaban 10mg per os is started on the first postoperative day. Patients receive Rivaroxaban 10mg QD for 7days (short arm) or 28 days (long arm)', 'armGroupLabels': ['A: Rivaroxaban short arm', 'B: Rivaroxaban long arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baden', 'country': 'Switzerland', 'facility': 'Kantonsspital Baden', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital, Inselspital Berne', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Clinic Beau-Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Guido Stirnimann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Berne, University Hospital, University of Berne, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}, {'name': 'Janssen Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}