[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547044":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":31,"locations":37,"responsibleParty":103,"collaborators":105,"id":109,"slug":23,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":23,"enrollmentInfo":118,"targetDuration":23,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":78,"whyStopped":23,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Hospital Sirio-Libanes","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Warfarin","ACTIVE_COMPARATOR","Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin.",[13],"Drug: Anticoagulant Oral",{"label":15,"type":16,"description":17,"interventionNames":18},"Edoxaban","EXPERIMENTAL","Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"No anticoagulation","NO_INTERVENTION","No oral anticoagulation should be used",null,[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Anticoagulant Oral","Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.",[15,9],[15,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":23,"email":36},"Lilian Barbosa, MBA","CONTACT","+55 11 98966 0550","lilian@bcri.org.br",[38,50,59,68,76,90],{"facility":39,"status":40,"city":41,"state":42,"zip":23,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":23},"Hospital Ana Nery","ACTIVE_NOT_RECRUITING","Salvador","Estado de Bahia","Brazil",{"type":45,"coordinates":46},"Point",[47,48],-38.49096,-12.97563,{"lat":48,"lon":47},{"facility":51,"status":40,"city":52,"state":53,"zip":23,"country":43,"cosmosGeoPoint":54,"geoPoint":58,"contacts":23},"Instituto de Cardiologia do DF","Brasília","Federal District",{"type":45,"coordinates":55},[56,57],-47.92972,-15.77972,{"lat":57,"lon":56},{"facility":60,"status":40,"city":61,"state":62,"zip":23,"country":43,"cosmosGeoPoint":63,"geoPoint":67,"contacts":23},"Hospital Universitário Maria Aparecida Pedrossian - EBSERH","Campo Grande","Mato Grosso do Sul",{"type":45,"coordinates":64},[65,66],-54.64639,-20.44278,{"lat":66,"lon":65},{"facility":69,"status":40,"city":70,"state":70,"zip":23,"country":43,"cosmosGeoPoint":71,"geoPoint":75,"contacts":23},"Sociedade Beneficente de Senhoras Hospital Sírio-Libanês","São Paulo",{"type":45,"coordinates":72},[73,74],-46.63611,-23.5475,{"lat":74,"lon":73},{"facility":77,"status":78,"city":79,"state":23,"zip":23,"country":43,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Hospital Universitário São Francisco na Providência de Deus","RECRUITING","Bragança Paulista",{"type":45,"coordinates":81},[82,83],-46.54418,-22.9527,{"lat":83,"lon":82},[86],{"name":87,"role":34,"phone":88,"phoneExt":23,"email":89},"Murillo O Antunes","+55 11 2503-377","dr.murilloantunes@gmail.com",{"facility":91,"status":78,"city":92,"state":23,"zip":23,"country":43,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Santa Casa de Misericórdia de Ponta Grossa","Ponta Grossa",{"type":45,"coordinates":94},[95,96],-50.16194,-25.095,{"lat":96,"lon":95},[99],{"name":100,"role":34,"phone":101,"phoneExt":23,"email":102},"Mario Cray","+55 42 3028-9494","mariocraydacosta@gmail.com",{"type":104,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[106],{"name":107,"class":108},"Daiichi Sankyo","INDUSTRY","100547044",false,"NCT06402851","Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)","A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction","VISIONAIRE","Inclusion Criteria:\n\n* Patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent);\n* CHA2DS2-Vasc ≥ 2 points (≥ 3 if female);\n* Chronic kidney disease with estimated glomerular filtration rate (eGFR) ≤ 15 ml\u002Fmin\u002F1.73 m2 by the CKD-EPI equation (confirmed by two lab results at least 3 months apart) or on chronic renal replacement therapy (Of note: number of patients included in no renal replacement therapy stratum will be capped at around 30% from the total study population).\n\nExclusion Criteria:\n\n* Active bleeding or severe bleeding \\\u003C 1 month;\n* Prior kidney transplantation;\n* Refusal de provide consent\n* Severe chronic liver disease (Child C);\n* Other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism);\n* Prior intracranial hemorrhage;\n* Bleeding disorder (other than uremia);\n* Platelet count \\\u003C 50,000 \u002F mm3 ;\n* Pregnancy or breastfeeding;\n* Mechanical valvar prosthesis;\n* Moderate to severe mitral stenosis;\n* Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker;\n* Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.","ALL","18 Years",{"count":119,"type":120},1500,"ESTIMATED","INTERVENTIONAL",[123],"PHASE4","VISIONAIRE (Vitamin K AntagonISt, Factor Xa Inhibitor Or Nothing In Atrial Fibrillation And DIalytic End-stage Renal DiseasE) trial will be a prospective randomized open-label with blinded endpoint adjudication trial including 1500 patients with atrial fibrillation or atrial flutter and advanced chronic kidney disease",[126,127],"Atrium; Fibrillation","Chronic Kidney Diseases",[129,130,131,132],"atrial fibrillation","atrial flutter","oral anticoagulation","dialysis","2025-02-19",{"date":135,"type":136},"2025-02-21","ACTUAL",{"date":138,"type":136},"2024-12-18",{"date":140,"type":120},"2026-12",{"name":5,"class":6},6]