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

NCT06402851 | Recruiting Phase 4 DMC

• 1 other identifier: AVAP-NG 3353
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 6

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

Conditions

Atrium; Fibrillation; Chronic Kidney Diseases

Keywords

atrial fibrillation; atrial flutter; oral anticoagulation; dialysis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Secondary efficacy endpoints

  24 months (median follow-up)

• Secondary efficacy endpoints

  24 months (median follow-up)

• Secondary efficacy endpoints

  24 months (median follow-up)

• Secondary efficacy endpoints

  24 months (median follow-up)

• Secondary safety endpoint

  24 months (median follow-up)

Other Outcomes (4)

• Exploratory endpoint

  12 months

• Exploratory endpoint

  24 months (median follow-up)

• Exploratory endpoint

  24 months (median follow-up)

Study Arms (3)

Warfarin

ACTIVE COMPARATOR

Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin.

Drug: Anticoagulant Oral

Edoxaban

EXPERIMENTAL

Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD.

Drug: Anticoagulant Oral

No anticoagulation

NO INTERVENTION

No oral anticoagulation should be used

Interventions

Anticoagulant Oral DRUG

Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.

Also known as: Edoxaban, Warfarin

Edoxaban; Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead
• Daiichi Sankyo: collaborator

Study Sites (6)

Hospital Ana Nery

Salvador, Estado de Bahia, Brazil

ACTIVE NOT RECRUITING

Instituto de Cardiologia do DF

Brasília, Federal District, Brazil

ACTIVE NOT RECRUITING

Hospital Universitário Maria Aparecida Pedrossian - EBSERH

Campo Grande, Mato Grosso do Sul, Brazil

ACTIVE NOT RECRUITING

Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

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

MeSH Terms

Conditions

Atrial Fibrillation; Renal Insufficiency, Chronic; Atrial Flutter

Interventions

Anticoagulants; edoxaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Lilian Barbosa, MBA

CONTACT

+55 11 98966 0550; lilian@bcri.org.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study endpoints will be assessed by an independent Clinical Events Committee (CEC), whose members will be unaware of randomized treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in 1:1:2 to warfarin, edoxaban or no OAC, stratified by renal replacement status.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (6)