NCT06402851 Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
| NCT ID | NCT06402851 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital Sirio-Libanes |
| Condition | Atrium; Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,500 participants in total. It began in 2024-12-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent); * CHA2DS2-Vasc ≥ 2 points (≥ 3 if female); * Chronic kidney disease with estimated glomerular filtration rate (eGFR) ≤ 15 ml/min/1.73 m2 by the CKD-EPI equation (confirmed by two lab results at least 3 months apart) or on chronic renal replacement therapy (Of note: number of patients included in no renal replacement therapy stratum will be capped at around 30% from the total study population). Exclusion Criteria: * Active bleeding or severe bleeding \< 1 month; * Prior kidney transplantation; * Refusal de provide consent * Severe chronic liver disease (Child C); * Other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism); * Prior intracranial hemorrhage; * Bleeding disorder (other than uremia); * Platelet count \< 50,000 / mm3 ; * Pregnancy or breastfeeding; * Mechanical valvar prosthesis; * Moderate to severe mitral stenosis; * Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker; * Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06402851 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrium; Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06402851 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06402851 currently recruiting?
Yes, NCT06402851 is actively recruiting participants. Contact the research team at lilian@bcri.org.br for enrollment information.
Where is the NCT06402851 trial being conducted?
This trial is being conducted at Salvador, Brazil, Brasília, Brazil, Campo Grande, Brazil, São Paulo, Brazil and 2 additional locations.
Who is sponsoring the NCT06402851 clinical trial?
NCT06402851 is sponsored by Hospital Sirio-Libanes. The trial plans to enroll 1,500 participants.