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

Hospital Sirio-Libanes

Status and phase: Enrolling; Phase 4

Conditions: Chronic Kidney Diseases; Atrium; Fibrillation

Treatments: Drug: Anticoagulant Oral

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06402851

AVAP-NG 3353

Details and patient eligibility

About

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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 3 patient groups

Warfarin

Active Comparator group

Description:

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

Treatment:

Drug: Anticoagulant Oral

Edoxaban

Experimental group

Description:

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

Treatment:

Drug: Anticoagulant Oral

No anticoagulation

No Intervention group

Description:

No oral anticoagulation should be used