NCT06402851RecruitingPhase 4
Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction
Source: ClinicalTrials.gov · Last updated 21 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 3 May 2024
- Start date
- 18 Dec 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Hospital Sirio-Libanes
- NCT number
- NCT06402851
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1500
- From 18 Dec 2024 to the primary completion date, Dec 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior kidney transplantation;
- Prior intracranial hemorrhage;
- Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker;
Other illness
- Active bleeding or severe bleeding \< 1 month;
- Severe chronic liver disease (Child C);
- Other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism);
- Bleeding disorder (other than uremia);
- Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.
Lab values
- Platelet count \< 50,000 / mm3 ;
Other
- Refusal de provide consent
- Pregnancy or breastfeeding;
- Mechanical valvar prosthesis;
- Moderate to severe mitral stenosis;
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitário São Francisco na Providência de Deus Coordinator of this site? Confirm its status | Bragança Paulista | Brazil | Recruiting |
| Instituto de Cardiologia do DF Coordinator of this site? Confirm its status | Brasília | Brazil | Active, not recruiting |
| Hospital Universitário Maria Aparecida Pedrossian - EBSERH Coordinator of this site? Confirm its status | Campo Grande | Brazil | Active, not recruiting |
| Santa Casa de Misericórdia de Ponta Grossa Coordinator of this site? Confirm its status | Ponta Grossa | Brazil | Recruiting |
| Hospital Ana Nery Coordinator of this site? Confirm its status | Salvador | Brazil | Active, not recruiting |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.