Atrium; Fibrillation, Chronic Kidney Diseases
Conditions
Keywords
atrial fibrillation, atrial flutter, oral anticoagulation, dialysis
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
Interventions
Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.
Sponsors
Daiichi Sankyo
Hospital Sirio-Libanes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All study endpoints will be assessed by an independent Clinical Events Committee (CEC), whose members will be unaware of randomized treatment assignment.
Intervention model description
Patients will be randomized in 1:1:2 to warfarin, edoxaban or no OAC, stratified by renal replacement status.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary efficacy endpoint | 24 months (median follow-up) | Time to first occurrence of the composite of stroke or systemic embolism |
| Primary safety endpoint: | 24 months (median follow-up) | Major or clinically relevant non-major bleeding according to the ISTH criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary safety endpoint | 24 months (median follow-up) | Time to first occurrence of major bleeding (ISTH) |
| Secondary efficacy endpoints | 24 months (median follow-up) | Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism |
| Net clinical endpoint | 24 months (median follow-up) | Time to first occurrence of CV death, MI, stroke, systemic embolism, fatal bleeding or bleeding into a critical organ |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory endpoint | 12 months | Quality of life by EQ-5D |
Countries
Brazil
Contacts
Primary ContactLilian Barbosa, MBA
Outcome results
None listed