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Recruiting NCT06402851

Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)

Phase IV Interventional Atrium; Fibrillation Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anticoagulant Oral.
Who it may be relevant to
Registry conditions: Atrium; Fibrillation, Chronic Kidney Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Primary efficacy endpoint [Time frame: 24 months (median follow-up)]
  • Primary safety endpoint: [Time frame: 24 months (median follow-up)]
Secondary outcome measures (9)
  • Secondary efficacy endpoints [Time frame: 24 months (median follow-up)]
  • Secondary efficacy endpoints [Time frame: 24 months (median follow-up)]
  • Secondary efficacy endpoints [Time frame: 24 months (median follow-up)]
  • Secondary efficacy endpoints [Time frame: 24 months (median follow-up)]
  • Secondary safety endpoint [Time frame: 24 months (median follow-up)]
  • Secondary safety endpoint [Time frame: 24 months (median follow-up)]
  • Secondary safety endpoint [Time frame: 24 months (median follow-up)]
  • Secondary safety endpoint [Time frame: 24 months (median follow-up)]
  • Net clinical endpoint [Time frame: 24 months (median follow-up)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Brazil · 6 centers
  • Hospital Ana Nery — Salvador
  • Instituto de Cardiologia do DF — Brasília
  • Hospital Universitário Maria Aparecida Pedrossian - EBSERH — Campo Grande
  • Sociedade Beneficente de Senhoras Hospital Sírio-Libanês — São Paulo
  • Hospital Universitário São Francisco na Providência de Deus — Bragança Paulista
  • Santa Casa de Misericórdia de Ponta Grossa — Ponta Grossa

Identifiers

NCT: NCT06402851 · AVAP-NG 3353

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗