Chronic Kidney Diseases Clinical Trial
— VISIONAIREOfficial title:
A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies For Patients With Atrial Fibrillation And Severe Chronic Kidney Dysfunction
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
Status | Not yet recruiting |
Enrollment | 1500 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 antiplatelet agents; - Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigatorĀ“s opinion, may impact survival in 12 months. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Sirio-Libanes | Daiichi Sankyo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory endpoint | Quality of life by EQ-5D | 12 months | |
Other | Exploratory endpoint | Access site bleeding | 24 months (median follow-up) | |
Other | Exploratory endpoint | Fistula or catheter thrombosis | 24 months (median follow-up) | |
Other | Exploratory endpoint | Fistula or catheter failure | 24 months (median follow-up) | |
Primary | Primary efficacy endpoint | Time to first occurrence of the composite of stroke or systemic embolism | 24 months (median follow-up) | |
Primary | Primary safety endpoint: | Major or clinically relevant non-major bleeding according to the ISTH criteria | 24 months (median follow-up) | |
Secondary | Secondary efficacy endpoints | Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism | 24 months (median follow-up) | |
Secondary | Secondary efficacy endpoints | Time to first occurrence of the composite of: CV death, MI, or stroke | 24 months (median follow-up) | |
Secondary | Secondary efficacy endpoints | Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke | 24 months (median follow-up) | |
Secondary | Secondary efficacy endpoints | All cause death | 24 months (median follow-up) | |
Secondary | Secondary safety endpoint | Time to first occurrence of major bleeding (ISTH) | 24 months (median follow-up) | |
Secondary | Secondary safety endpoint | Time to first occurrence of GUSTO moderate or severe bleeding | 24 months (median follow-up) | |
Secondary | Secondary safety endpoint | Time to first occurrence of TIMI minor and major bleeding | 24 months (median follow-up) | |
Secondary | Secondary safety endpoint | Fatal or intra-cranial bleeding | 24 months (median follow-up) | |
Secondary | Net clinical endpoint | Time to first occurrence of CV death, MI, stroke, systemic embolism, fatal bleeding or bleeding into a critical organ | 24 months (median follow-up) |
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