A Phase 4 interventional study of Anticoagulant Oral in Atrium; Fibrillation and Chronic Kidney Diseases, sponsored by Hospital Sirio-Libanes. Recruiting at 6 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Hospital Sirio-Libanes · Phase 4, Interventional, and Treatment
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
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Hospital Sirio-Libanes is the lead sponsor of 44 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin.
Drug: Anticoagulant Oral
Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD.
Drug: Anticoagulant Oral
No oral anticoagulation should be used
Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.
Also known as: Edoxaban, Warfarin
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)
Secondary 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)
Exploratory endpoint
Quality of life by EQ-5D
Time frame: 12 months
Exploratory endpoint
Access site bleeding
Time frame: 24 months (median follow-up)
Exploratory endpoint
Fistula or catheter thrombosis
Time frame: 24 months (median follow-up)
Exploratory endpoint
Fistula or catheter failure
Time frame: 24 months (median follow-up)
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No — After publication of study primary results in a peer-reviewed scientific medical journal, interested parts in data sharing are welcome to contact the corresponding author directly.
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.
Of 129 non-industry phase 4 interventional studies under Atrial Fibrillation, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 81. This study's planned 24 months is below that.
Counting every sponsor, half of 141 studies reached it within 48 months; a quarter within 27 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Hospital Sirio-Libanes