Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
Recruiting · NCT06402851 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Sirio-Libanes
View the official record on ClinicalTrials.gov →Interventions studied
Anticoagulant Oral
What this trial is 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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
12 locations listed.
- Hospital Universitário São Francisco na Providência de Deus - Bragança Paulista, Brazil
- Hospital Universitário São Francisco na Providência de Deus - Bragança Paulista, Brazil
- Santa Casa de Misericórdia de Ponta Grossa - Ponta Grossa, Brazil
- Santa Casa de Misericórdia de Ponta Grossa - Ponta Grossa, Brazil
- Hospital Ana Nery - Salvador, Estado de Bahia, Brazil
- Hospital Ana Nery - Salvador, Estado de Bahia, Brazil
- Instituto de Cardiologia do DF - Brasília, Federal District, Brazil
- Instituto de Cardiologia do DF - Brasília, Federal District, Brazil
- Hospital Universitário Maria Aparecida Pedrossian - EBSERH - Campo Grande, Mato Grosso do Sul, Brazil
- Hospital Universitário Maria Aparecida Pedrossian - EBSERH - Campo Grande, Mato Grosso do Sul, Brazil
- Sociedade Beneficente de Senhoras Hospital Sírio-Libanês - São Paulo, São Paulo, Brazil
- Sociedade Beneficente de Senhoras Hospital Sírio-Libanês - São Paulo, São Paulo, Brazil