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New treatment option for Atrium; Fibrillation
Official title Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
ClinicalTrials.gov ID: NCT06402851
What this study is testing
What is Anticoagulant Oral?
Anticoagulant Oral is an investigational medicine, being studied as a potential treatment for atrium; fibrillation.
Also referred to as Edoxaban, Warfarin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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;
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Salvador, Estado de Bahia, Brazil
- Brasília, Federal District, Brazil
- Campo Grande, Mato Grosso do Sul, Brazil
- São Paulo, São Paulo, Brazil
- Bragança Paulista, Brazil
- Ponta Grossa, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salvador, Estado de Bahia, Brazil; Brasília, Federal District, Brazil; Campo Grande, Mato Grosso do Sul, Brazil; São Paulo, São Paulo, Brazil; Bragança Paulista, Brazil; Ponta Grossa, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.