Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction
Hospital Sirio-Libanes
1,500 participants
Dec 18, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria3
- 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 Criteria13
- 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.
Interventions
Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06402851