[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583207":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":26,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Science Valley Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"study arm","EXPERIMENTAL","Rivaroxaban 2.5 mg bid + aspirin 100 mg",[13],"Drug: rivaroxaban 2.5 mg bid + aspirin 100 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"comparator","ACTIVE_COMPARATOR","clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures",[19],"Drug: clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","rivaroxaban 2.5 mg bid + aspirin 100 mg","rivaroxaban 2.5 mg bid + aspirin",[9],null,{"type":22,"name":17,"description":15,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"affiliation":32,"role":33},"Eduardo Ramacciotti, MD, Ph.D.","Science Valley","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Gabriela Oliveira Buril, MD","CONTACT","+5581991121872","gabriela.buril@ufpe.br",[41],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hospital das Clínicas, Federal University of Pernambuco","RECRUITING","Pernambuco","50740-900","Brazil","BR",{"type":49,"coordinates":50},"Point",[51,52],-37.7,-8.78333,{"lat":52,"lon":51},[55,56,57],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":36,"role":37,"phone":26,"phoneExt":26,"email":26},{"name":58,"role":37,"phone":26,"phoneExt":26,"email":26},"Eduardo Ramacciotti, MD, Ph.D",{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100583207","phase-4-vte-incidence-after-rivaroxaban--aspirin-or-sapt-after-lower-limb-revascularization-100583207",false,"NCT06873321","VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization","Incidence of Venous Thromboembolism After Lower Limb Revascularization in Patients Receiving Rivaroxaban 2.5 Mg Bid + Aspirin 100 Mg Versus Single Antiplatelet Treatment - a Randomized Clinical Trial","RESOLUTION","Inclusion Criteria:\n\n1. Be adults of any age and gender.\n2. Have critical limb ischemia with a proposed revascularization treatment (either via ATP or bypass surgery) at the Vascular Surgery Service of HC\u002FEBSERH - UFPE.\n3. Sign the informed consent form (ICF) (Appendix 2).\n\nExclusion Criteria:\n\n1. Experience a symptomatic VTE event during hospitalization, as they will require full anticoagulation rather than prophylactic anticoagulation.\n2. Have any contraindications to Rivaroxaban.\n3. Do not return for the 30-day postoperative follow-up visit.","ALL",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","Venous thromboembolism (VTE) has a high prevalence in patients with multiple comorbidities undergoing complex surgical procedures. Sometimes, extended prophylaxis for VTE with KLMWH or direct oral anticoagulants (DOACs) is necessary. Currently, there is no consensus in the literature regarding the use of DOACs for extended VTE prophylaxis in patients undergoing lower limb revascularization (LLR). Objective: To evaluate the use of DOACs (already approved to reduce MACE and MALE) in VTE prophylaxis in patients undergoing LLR.",[78,79,80,81],"Peripheral Arterial Disease","Venous Thormboembolism","Cardiovascular Diseases","Vascular Surgery Patient with PAD \u002F Carotid Stenosis",[78,83,84,85,86,87],"chronic limb-threatening ischemia","Deep Vein Thrombosis","venous thromboembolism","Factor Xa Inhibitors","rivaroxaban","2025-03-06",{"date":90,"type":91},"2025-03-12","ACTUAL",{"date":93,"type":91},"2024-02-24",{"date":95,"type":72},"2025-07-30",{"name":5,"class":6},1]