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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (6)

Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
Instituto de Cardiologia do DF
Brasília, Federal District, Brazil
Hospital Universitário Maria Aparecida Pedrossian - EBSERH
Campo Grande, Mato Grosso do Sul, Brazil
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, Brazil
Santa Casa de Misericórdia de Ponta Grossa
Ponta Grossa, Brazil