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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06402851
Other study ID # AVAP-NG 3353
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date July 2024
Est. completion date December 2026

Study information

Verified date May 2024
Source Hospital Sirio-Libanes
Contact Lilian Barbosa, MBA
Phone +55 11 98966 0550
Email lilian@bcri.org.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Anticoagulant Oral
Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Hospital Sirio-Libanes Daiichi Sankyo

Outcome

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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