Last updated 31 days ago
Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
1500 patients around the world
Available in Brazil
Hospital Sirio-Libanes
1Research sites
1500Patients around the world
This study is for people with
Renal disease
End-stage renal disease
Cardiac arrhythmia
Atrial fibrillation
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent).CHA2DS2-Vasc ≥ 2 points (≥ 3 if female).Chronic kidney disease with estimated glomerular filtration rate (eGFR) ≤ 15 ml/min/1.73 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).
- Active bleeding or severe bleeding < 1 month.Prior kidney transplantation.Refusal de provide consent.Severe chronic liver disease (Child C).Other indication of oral anticoagulation (e.g., venous thromboembolism or pulmonary embolism).Prior intracranial hemorrhage.Bleeding disorder (other than uremia).Platelet count < 50,000 / mm3.Pregnancy or breastfeeding.Mechanical valvar prosthesis.Moderate to severe mitral stenosis.Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker.Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.
Sites
Hospital Universitario Sao Francisco na Providencia de Deus
Recruiting
StudyVISIONAIRE
SponsorHospital Sirio-Libanes
Study typeInterventional
Conditions
End-stage renal diseaseAtrial fibrillation
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06402851
