RecruitingPhase 4NCT06402851

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


Sponsor

Hospital Sirio-Libanes

Enrollment

1,500 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (VISIONAIRE) is comparing three approaches to preventing strokes in patients with both atrial fibrillation and severe kidney disease (end-stage renal disease): a vitamin K antagonist, a factor Xa inhibitor, or no anticoagulation. **You may be eligible if...** - You have confirmed atrial fibrillation or flutter (paroxysmal, persistent, or permanent) - Your stroke risk score (CHA2DS2-VASc) is 2 or higher (3 or higher if female) - You have severe kidney disease (eGFR ≤15 or on dialysis) **You may NOT be eligible if...** - You are actively bleeding or had a serious bleed within the past month - You have had a prior kidney transplant - You have a mechanical heart valve or significant mitral valve narrowing - You have had a prior bleed inside the skull - You have severe liver disease (Child-Pugh class C) - You are pregnant or breastfeeding - You have another reason requiring blood thinners (e.g., recent blood clots) - Your platelet count is very low (below 50,000/mm³) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnticoagulant 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

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NCT06402851


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