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

Phase 4

Recruiting

• Conditions: Chronic Kidney Diseases; Atrium; Fibrillation
• Interventions: Drug: Anticoagulant Oral

• Registration Number: NCT06402851
• Lead Sponsor: Hospital Sirio-Libanes

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Study First Posted: 2024-05-07
• Study Start: 2024-12-18
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edoxaban	Anticoagulant Oral	Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD.
Warfarin	Anticoagulant Oral	Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Net clinical endpoint	24 months (median follow-up)	Time to first occurrence of CV death, MI, stroke, systemic embolism, fatal bleeding or bleeding into a critical organ
Secondary efficacy endpoints	24 months (median follow-up)	All cause death
Secondary safety endpoint	24 months (median follow-up)	Fatal or intra-cranial bleeding

Trial Locations

Locations (6)

Hospital Ana Nery; 🇧🇷 Salvador, BA, Brazil

Instituto de Cardiologia do DF; 🇧🇷 Brasilia, DF, Brazil

Hospital Universitário Maria Aparecida Pedrossian - EBSERH; 🇧🇷 Campo Grande, MS, Brazil

Sociedade Beneficente de Senhoras Hospital Sírio-Libanês; 🇧🇷 Sao Paulo, São Paulo, Brazil

Hospital Universitário São Francisco na Providência de Deus; 🇧🇷 Braganca Paulista, Brazil

Santa Casa de Misericórdia de Ponta Grossa; 🇧🇷 Ponta Grossa, Brazil