Clinical Trials - DataSource by Daiichi Sankyo

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

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

PRODUCT

Edoxaban

GENDER

ALL

AGE

18 Years

SPONSOR

Hospital Sirio-Libanes

COLLABORATOR

Daiichi Sankyo

TRIAL RUNS IN

6 Global Locations

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

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).

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.

This was last updated on 2025-11-06 19:34:45.414.

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