Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0333
Source ID: NCT06402851
Associated Drug: Anticoagulant Oral
Title: Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
Acronym: VISIONAIRE
Status: RECRUITING
Study Results: NO
Results:
Conditions: Atrium; Fibrillation|Chronic Kidney Diseases
Interventions: DRUG: Anticoagulant Oral
Outcome Measures: Primary: Primary efficacy endpoint, Time to first occurrence of the composite of stroke or systemic embolism, 24 months (median follow-up)|Primary safety endpoint:, Major or clinically relevant non-major bleeding according to the ISTH criteria, 24 months (median follow-up) | Secondary: Secondary efficacy endpoints, Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism, 24 months (median follow-up)|Secondary efficacy endpoints, Time to first occurrence of the composite of: CV death, MI, or stroke, 24 months (median follow-up)|Secondary efficacy endpoints, Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke, 24 months (median follow-up)|Secondary efficacy endpoints, All cause death, 24 months (median follow-up)|Secondary safety endpoint, Time to first occurrence of major bleeding (ISTH), 24 months (median follow-up)|Secondary safety endpoint, Time to first occurrence of GUSTO moderate or severe bleeding, 24 months (median follow-up)|Secondary safety endpoint, Time to first occurrence of TIMI minor and major bleeding, 24 months (median follow-up)|Secondary safety endpoint, Fatal or intra-cranial bleeding, 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, 24 months (median follow-up) | Other: Exploratory endpoint, Quality of life by EQ-5D, 12 months|Exploratory endpoint, Access site bleeding, 24 months (median follow-up)|Exploratory endpoint, Fistula or catheter thrombosis, 24 months (median follow-up)|Exploratory endpoint, Fistula or catheter failure, 24 months (median follow-up)
Sponsor/Collaborators: Sponsor: Hospital Sirio-Libanes | Collaborators: Daiichi Sankyo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 1500
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-18
Completion Date: 2026-12
Results First Posted:
Last Update Posted: 2025-02-21
Locations: Hospital Ana Nery, Salvador, BA, Brazil|Instituto de Cardiologia do DF, Brasilia, DF, Brazil|Hospital Universitário Maria Aparecida Pedrossian - EBSERH, Campo Grande, MS, Brazil|Sociedade Beneficente de Senhoras Hospital Sírio-Libanês, Sao Paulo, São Paulo, Brazil|Hospital Universitário São Francisco na Providência de Deus, Braganca Paulista, Brazil|Santa Casa de Misericórdia de Ponta Grossa, Ponta Grossa, Brazil
URL: https://clinicaltrials.gov/show/NCT06402851

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress