Clinical trial NCT06402851: Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
Official title: A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atrium; Fibrillation
Chronic Kidney Diseases
Keywords: atrial fibrillation
atrial flutter
oral anticoagulation
dialysis
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
First posted: 2024-05-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in 1:1:2 to warfarin, edoxaban or no OAC, stratified by renal replacement status.
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Primary efficacy endpoint
timeFrame: 24 months (median follow-up)
measure: Primary safety endpoint:
timeFrame: 24 months (median follow-up)
Secondary outcomes:
measure: Secondary efficacy endpoints
timeFrame: 24 months (median follow-up)
measure: Secondary efficacy endpoints
timeFrame: 24 months (median follow-up)
measure: Secondary efficacy endpoints
timeFrame: 24 months (median follow-up)
measure: Secondary efficacy endpoints
timeFrame: 24 months (median follow-up)
measure: Secondary safety endpoint
timeFrame: 24 months (median follow-up)
measure: Secondary safety endpoint
timeFrame: 24 months (median follow-up)
measure: Secondary safety endpoint
timeFrame: 24 months (median follow-up)
measure: Secondary safety endpoint
timeFrame: 24 months (median follow-up)
measure: Net clinical endpoint
timeFrame: 24 months (median follow-up)
Other outcomes:
measure: Exploratory endpoint
timeFrame: 12 months
measure: Exploratory endpoint
timeFrame: 24 months (median follow-up)
measure: Exploratory endpoint
timeFrame: 24 months (median follow-up)
measure: Exploratory endpoint
timeFrame: 24 months (median follow-up)
Locations:
city: Salvador
country: Brazil
facility: Hospital Ana Nery
state: BA
city: Brasilia
country: Brazil
facility: Instituto de Cardiologia do DF
state: DF
city: Campo Grande
country: Brazil
facility: Hospital Universitário Maria Aparecida Pedrossian - EBSERH
state: MS
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
state: São Paulo
city: Braganca Paulista
country: Brazil
facility: Hospital Universitário São Francisco na Providência de Deus
city: Ponta Grossa
country: Brazil
facility: Santa Casa de Misericórdia de Ponta Grossa
Study officials:
References: