Comparing anticoagulants for patients with atrial fibrillation and severe kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitário São Francisco na Providência de Deus
  Bragança Paulista, Brazil Recruiting
• Santa Casa de Misericórdia de Ponta Grossa
  Ponta Grossa, Brazil Recruiting
• 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

Study contacts

• Study coordinator: Lilian Barbosa, MBA
• Email: lilian@bcri.org.br
• Phone: +55 11 98966 0550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.