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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-18

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Atrium; Fibrillation Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

All study endpoints will be assessed by an independent Clinical Events Committee (CEC), whose members will be unaware of randomized treatment assignment.

Study Groups

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Warfarin

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

Group Type ACTIVE_COMPARATOR

Anticoagulant Oral

Intervention Type DRUG

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

Edoxaban

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

Group Type EXPERIMENTAL

Anticoagulant Oral

Intervention Type DRUG

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

No anticoagulation

No oral anticoagulation should be used

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Anticoagulant Oral

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

Intervention Type DRUG

Other Intervention Names

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Edoxaban Warfarin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No