Actively Recruiting
Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
Led by Hospital Sirio-Libanes · Updated on 2025-02-21
1500
Participants Needed
6
Research Sites
101 weeks
Total Duration
On this page
Sponsors
H
Hospital Sirio-Libanes
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
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
CONDITIONS
Official Title
Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent)
- CHA2DS2-Vasc score of 2 or more points (3 or more if female)
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) 15 ml/min/1.73 m2 or less confirmed by two lab tests at least 3 months apart, or on chronic renal replacement therapy
- Patients must be 18 years or older
You will not qualify if you...
- Active bleeding or severe bleeding within the last month
- Prior kidney transplantation
- Refusal to provide consent
- Severe chronic liver disease (Child C)
- Other reasons for oral anticoagulation such as venous thromboembolism or pulmonary embolism
- Prior intracranial hemorrhage
- Bleeding disorders other than uremia
- Platelet count below 50,000 per mm3
- Pregnancy or breastfeeding
- Mechanical heart valve prosthesis
- Moderate to severe mitral valve stenosis
- Need for antithrombotic drugs other than a single antiplatelet agent, or need for dual antiplatelet therapy
- Any other serious health condition beyond chronic kidney disease and cardiovascular disease that may affect survival within 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
Active, Not Recruiting
2
Instituto de Cardiologia do DF
Brasília, Federal District, Brazil
Active, Not Recruiting
3
Hospital Universitário Maria Aparecida Pedrossian - EBSERH
Campo Grande, Mato Grosso do Sul, Brazil
Active, Not Recruiting
4
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Active, Not Recruiting
5
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, Brazil
Actively Recruiting
6
Santa Casa de Misericórdia de Ponta Grossa
Ponta Grossa, Brazil
Actively Recruiting
Research Team
L
Lilian Barbosa, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here