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

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Atrium; Fibrillation
• Intervention / Treatment: Drug: Anticoagulant Oral

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lilian Barbosa, MBA; Phone Number: +55 11 98966 0550; Email: lilian@bcri.org.br

Study Locations

• Brazil
  • Braganca Paulista, Brazil
    • Recruiting
    • Hospital Universitário São Francisco na Providência de Deus
    • Contact: Murillo O Antunes; Phone Number: +55 11 2503-377; Email: dr.murilloantunes@gmail.com
  • Ponta Grossa, Brazil
    • Recruiting
    • Santa Casa de Misericórdia de Ponta Grossa
    • Contact: Mario Cray; Phone Number: +55 42 3028-9494; Email: mariocraydacosta@gmail.com
  • BA
    • Salvador, BA, Brazil
      • Active, not recruiting
      • Hospital Ana Nery
  • DF
    • Brasilia, DF, Brazil
      • Active, not recruiting
      • Instituto de Cardiologia do DF
  • MS
    • Campo Grande, MS, Brazil
      • Active, not recruiting
      • Hospital Universitário Maria Aparecida Pedrossian - EBSERH
  • São Paulo
    • Sao Paulo, São Paulo, Brazil
      • Active, not recruiting
      • Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No anticoagulation; No oral anticoagulation should be used
Active Comparator: Warfarin; Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin.	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.; Other Names: Edoxaban; Warfarin
Experimental: Edoxaban; Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD.	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.; Other Names: Edoxaban; Warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy endpoint	Time to first occurrence of the composite of stroke or systemic embolism	24 months (median follow-up)
Primary safety endpoint:	Major or clinically relevant non-major bleeding according to the ISTH criteria	24 months (median follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary efficacy endpoints	Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism	24 months (median follow-up)
Secondary efficacy endpoints	Time to first occurrence of the composite of: CV death, MI, or stroke	24 months (median follow-up)
Secondary efficacy endpoints	Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke	24 months (median follow-up)
Secondary efficacy endpoints	All cause death	24 months (median follow-up)
Secondary safety endpoint	Time to first occurrence of major bleeding (ISTH)	24 months (median follow-up)
Secondary safety endpoint	Time to first occurrence of GUSTO moderate or severe bleeding	24 months (median follow-up)
Secondary safety endpoint	Time to first occurrence of TIMI minor and major bleeding	24 months (median follow-up)
Secondary safety endpoint	Fatal or intra-cranial bleeding	24 months (median follow-up)
Net clinical endpoint	Time to first occurrence of CV death, MI, stroke, systemic embolism, fatal bleeding or bleeding into a critical organ	24 months (median follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory endpoint	Quality of life by EQ-5D	12 months
Exploratory endpoint	Access site bleeding	24 months (median follow-up)
Exploratory endpoint	Fistula or catheter thrombosis	24 months (median follow-up)
Exploratory endpoint	Fistula or catheter failure	24 months (median follow-up)

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes
• Collaborators: Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: atrial fibrillation; dialysis; oral anticoagulation; atrial flutter
• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Arrhythmias, Cardiac; Renal Insufficiency; Atrial Fibrillation; Kidney Diseases; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Warfarin; Anticoagulants; Edoxaban
• Other Study ID Numbers: AVAP-NG 3353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After publication of study primary results in a peer-reviewed scientific medical journal, interested parts in data sharing are welcome to contact the corresponding author directly.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No