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Clinical Trials in Brazil / NCT06402851
Recruiting Phase 4

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

NCT06402851 · tracked via the Priya Life Science Brazil tracker
Phase
Phase 4
Started
2024-12-18
Last updated
2025-02-21

Condition(s) studied

Atrium; FibrillationChronic Kidney Diseases

Investigational drug(s) / intervention(s)

Anticoagulant Oral →

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)

Trial sites (6)

FacilityCityRegionStatus
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 Bragança Paulista Brazil Recruiting
Santa Casa de Misericórdia de Ponta Grossa Ponta Grossa Brazil Recruiting

More Hospital Sirio-Libanes trials in Brazil

Other trials for the same condition

Official registry record

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.

View NCT06402851 on ClinicalTrials.gov ↗ ← All trials in Brazil