Anticoagulant Oral: Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Primary efficacy endpoint — 24 months (median follow-up) Time to first occurrence of the composite of stroke or systemic embolism
Primary safety endpoint: — 24 months (median follow-up) Major or clinically relevant non-major bleeding according to the ISTH criteria
Trial sites (6)
Facility
City
Region
Status
Hospital Ana Nery
Salvador
Estado de Bahia
Active Not Recruiting
Instituto de Cardiologia do DF
Brasília
Federal District
Active Not Recruiting
Hospital Universitário Maria Aparecida Pedrossian - EBSERH
Campo Grande
Mato Grosso do Sul
Active Not Recruiting
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo
São Paulo
Active Not Recruiting
Hospital Universitário São Francisco na Providência de Deus
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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