[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547044":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":31,"locations":37,"responsibleParty":104,"collaborators":106,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":23,"enrollmentInfo":120,"targetDuration":23,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":79,"whyStopped":23,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"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",[38,51,60,69,77,91],{"facility":39,"status":40,"city":41,"state":42,"zip":23,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":23},"Hospital Ana Nery","ACTIVE_NOT_RECRUITING","Salvador","Estado de Bahia","Brazil","BR",{"type":46,"coordinates":47},"Point",[48,49],-38.49096,-12.97563,{"lat":49,"lon":48},{"facility":52,"status":40,"city":53,"state":54,"zip":23,"country":43,"countryCode":44,"cosmosGeoPoint":55,"geoPoint":59,"contacts":23},"Instituto de Cardiologia do DF","Brasília","Federal District",{"type":46,"coordinates":56},[57,58],-47.92972,-15.77972,{"lat":58,"lon":57},{"facility":61,"status":40,"city":62,"state":63,"zip":23,"country":43,"countryCode":44,"cosmosGeoPoint":64,"geoPoint":68,"contacts":23},"Hospital Universitário Maria Aparecida Pedrossian - EBSERH","Campo Grande","Mato Grosso do Sul",{"type":46,"coordinates":65},[66,67],-54.64639,-20.44278,{"lat":67,"lon":66},{"facility":70,"status":40,"city":71,"state":71,"zip":23,"country":43,"countryCode":44,"cosmosGeoPoint":72,"geoPoint":76,"contacts":23},"Sociedade Beneficente de Senhoras Hospital Sírio-Libanês","São Paulo",{"type":46,"coordinates":73},[74,75],-46.63611,-23.5475,{"lat":75,"lon":74},{"facility":78,"status":79,"city":80,"state":23,"zip":23,"country":43,"countryCode":44,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Hospital Universitário São Francisco na Providência de Deus","RECRUITING","Bragança Paulista",{"type":46,"coordinates":82},[83,84],-46.54418,-22.9527,{"lat":84,"lon":83},[87],{"name":88,"role":34,"phone":89,"phoneExt":23,"email":90},"Murillo O Antunes","+55 11 2503-377","dr.murilloantunes@gmail.com",{"facility":92,"status":79,"city":93,"state":23,"zip":23,"country":43,"countryCode":44,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Santa Casa de Misericórdia de Ponta Grossa","Ponta Grossa",{"type":46,"coordinates":95},[96,97],-50.16194,-25.095,{"lat":97,"lon":96},[100],{"name":101,"role":34,"phone":102,"phoneExt":23,"email":103},"Mario Cray","+55 42 3028-9494","mariocraydacosta@gmail.com",{"type":105,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[107],{"name":108,"class":109},"Daiichi Sankyo","INDUSTRY","100547044","phase-4-vitamin-k-antagonist-factor-xa-inhibitor-or-no-anticoagulation-in-atrial-fibrillation-and-dialytic-end-stage-renal-disease-visionaire-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":121,"type":122},1500,"ESTIMATED","INTERVENTIONAL",[125],"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",[128,129],"Atrium; Fibrillation","Chronic Kidney Diseases",[131,132,133,134],"atrial fibrillation","atrial flutter","oral anticoagulation","dialysis","2025-02-19",{"date":137,"type":138},"2025-02-21","ACTUAL",{"date":140,"type":138},"2024-12-18",{"date":142,"type":122},"2026-12",{"name":5,"class":6},6]