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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,500
Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
ACTIVE_NOT_RECRUITINGInstituto de Cardiologia do DF
Brasília, Federal District, Brazil
ACTIVE_NOT_RECRUITINGHospital Universitário Maria Aparecida Pedrossian - EBSERH
Campo Grande, Mato Grosso do Sul, Brazil
Primary efficacy endpoint
Time to first occurrence of the composite of stroke or systemic embolism
Time frame: 24 months (median follow-up)
Primary safety endpoint:
Major or clinically relevant non-major bleeding according to the ISTH criteria
Time frame: 24 months (median follow-up)
Secondary efficacy endpoints
Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism
Time frame: 24 months (median follow-up)
Secondary efficacy endpoints
Time to first occurrence of the composite of: CV death, MI, or stroke
Time frame: 24 months (median follow-up)
Secondary efficacy endpoints
Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke
Time frame: 24 months (median follow-up)
Secondary efficacy endpoints
All cause death
Time frame: 24 months (median follow-up)
Secondary safety endpoint
Time to first occurrence of major bleeding (ISTH)
Time frame: 24 months (median follow-up)
Secondary safety endpoint
Time to first occurrence of GUSTO moderate or severe bleeding
Time frame: 24 months (median follow-up)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
ACTIVE_NOT_RECRUITINGHospital Universitário São Francisco na Providência de Deus
Bragança Paulista, Brazil
RECRUITINGSanta Casa de Misericórdia de Ponta Grossa
Ponta Grossa, Brazil
RECRUITINGSecondary safety endpoint
Time to first occurrence of TIMI minor and major bleeding
Time frame: 24 months (median follow-up)
Secondary safety endpoint
Fatal or intra-cranial bleeding
Time frame: 24 months (median follow-up)
Net clinical endpoint
Time to first occurrence of CV death, MI, stroke, systemic embolism, fatal bleeding or bleeding into a critical organ
Time frame: 24 months (median follow-up)