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);
Parallel
Anticoagulant Oral
DrugPatients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.
Primary efficacy endpoint
Time to first occurrence of the composite of stroke or systemic embolism
Primary safety endpoint:
Major or clinically relevant non-major bleeding according to the ISTH criteria
Secondary efficacy endpoints
Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism
Secondary efficacy endpoints
Time to first occurrence of the composite of: CV death, MI, or stroke
Secondary efficacy endpoints
Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke
Secondary efficacy endpoints
All cause death
Exploratory endpoint
Quality of life by EQ-5D
Exploratory endpoint
Access site bleeding
Exploratory endpoint
Fistula or catheter thrombosis
Exploratory endpoint
Fistula or catheter failure
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Hospital Sirio-Libanes
Lead sponsor
Daiichi Sankyo
Collaborator
