Anticoagulant Oral
DrugPatients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.
Other names: Edoxaban, Warfarin
NCT Number: NCT06402851
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Hospital Ana Nery, Salvador, Estado de Bahia, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.
Other names: Edoxaban, Warfarin
Time frame: 24 months (median follow-up)
Time to first occurrence of the composite of stroke or systemic embolism
Time frame: 24 months (median follow-up)
Major or clinically relevant non-major bleeding according to the ISTH criteria
Time frame: 24 months (median follow-up)
Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism
Time frame: 24 months (median follow-up)
Time to first occurrence of the composite of: CV death, MI, or stroke
Time frame: 24 months (median follow-up)
Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke
Time frame: 24 months (median follow-up)
All cause death
Time frame: 24 months (median follow-up)
Time to first occurrence of major bleeding (ISTH)
Time frame: 24 months (median follow-up)
Time to first occurrence of GUSTO moderate or severe bleeding
Time frame: 24 months (median follow-up)
Time to first occurrence of TIMI minor and major bleeding
Time frame: 24 months (median follow-up)
Fatal or intra-cranial bleeding
Time frame: 24 months (median follow-up)
Time to first occurrence of CV death, MI, stroke, systemic embolism, fatal bleeding or bleeding into a critical organ
Time frame: 12 months
Quality of life by EQ-5D
Time frame: 24 months (median follow-up)
Access site bleeding
Time frame: 24 months (median follow-up)
Fistula or catheter thrombosis
Time frame: 24 months (median follow-up)
Fistula or catheter failure
Contact information is provided by the study sponsor or research team.
Hospital Sirio-Libanes
Other
A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction
Acronym: VISIONAIRE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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