Compares blood-thinning strategies in atrial fibrillation with severe kidney disease
Tests blood thinners, or none, in adults with atrial fibrillation and advanced kidney disease.
Plain-language title generated from the registry record
Registry title: Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
Key facts
- Where
- Bragança Paulista, Brasília, Campo Grande, Ponta Grossa, Salvador, and São Paulo, BrazilSee the 6 sites
- Phase
- Phase 4
Where in Brazil
- Hospital Universitário São Francisco na Providência de DeusBragança Paulista, BrazilTaking people
- Instituto de Cardiologia do DFBrasília, BrazilNo longer taking part
- Hospital Universitário Maria Aparecida Pedrossian - EBSERHCampo Grande, BrazilNo longer taking part
- Santa Casa de Misericórdia de Ponta GrossaPonta Grossa, BrazilTaking people
- Hospital Ana NerySalvador, BrazilNo longer taking part
- Sociedade Beneficente de Senhoras Hospital Sirio LibanesSão Paulo, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Sirio-Libanes
- Trial code
- NCT06402851
- Record updated
- 21 February 2025
- Original description
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 diseaseRead full original descriptionShow less
A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction
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
Inclusion: 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: Prior kidney transplantation; Prior intracranial hemorrhage; Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker; Active bleeding or severe bleeding < 1 month; Severe chronic liver disease (Child C); Other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism); Bleeding disorder (other than uremia); Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months; Platelet count < 50,000 / mm3 ; Refusal de provide consent; Pregnancy or breastfeeding; Mechanical valvar prosthesis; Moderate to severe mitral stenosis.