Comparing anticoagulants for patients with atrial fibrillation and severe kidney disease
A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction
This study is testing whether different blood-thinning medications can help people with atrial fibrillation and severe kidney disease stay healthier and avoid complications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Sirio-Libanes Academic / other |
| Locations | 6 sites (Salvador, Estado de Bahia and 5 other locations) |
| Trial ID | NCT06402851 on ClinicalTrials.gov |
What this trial studies
The VISIONAIRE trial is a prospective randomized open-label trial that aims to evaluate the effectiveness of vitamin K antagonists, Factor Xa inhibitors, or no anticoagulation in patients with atrial fibrillation or flutter who also have advanced chronic kidney disease. The study will enroll 1500 patients with a CHA2DS2-Vasc score of 2 or higher, focusing on those with an estimated glomerular filtration rate of 15 ml/min/1.73 m² or lower. Participants will be monitored for outcomes related to anticoagulation therapy and its impact on their condition.
Who should consider this trial
Good fit: Ideal candidates include patients with atrial fibrillation or flutter and advanced chronic kidney disease requiring anticoagulation.
Not a fit: Patients with active bleeding, severe liver disease, or those who have had prior kidney transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safest and most effective anticoagulation strategies for patients with atrial fibrillation and severe kidney disease.
How similar studies have performed: Other studies have explored anticoagulation in similar populations, but this specific comparison of treatment options in patients with severe kidney disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Salvador, Estado de Bahia and 5 other locations
- Hospital Ana Nery — Salvador, Estado de Bahia, Brazil (Active_not_recruiting)
- Instituto de Cardiologia do DF — Brasília, Federal District, Brazil (Active_not_recruiting)
- Hospital Universitário Maria Aparecida Pedrossian - EBSERH — Campo Grande, Mato Grosso do Sul, Brazil (Active_not_recruiting)
- Sociedade Beneficente de Senhoras Hospital Sírio-Libanês — São Paulo, São Paulo, Brazil (Active_not_recruiting)
- Hospital Universitário São Francisco na Providência de Deus — Bragança Paulista, Brazil (Recruiting)
- Santa Casa de Misericórdia de Ponta Grossa — Ponta Grossa, Brazil (Recruiting)
Study contacts
- Study coordinator: Lilian Barbosa, MBA
- Email: lilian@bcri.org.br
- Phone: +55 11 98966 0550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.