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
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);
Hospital Sirio-Libanes
Lead sponsor
Daiichi Sankyo
Collaborator