Vitamin K AntagonISt, Factor Xa Inhibitor Or Nothing In Atrial Fibrillation And DIalytic End-stage Renal DiseasE (VISIONAIRE)

Chronic Kidney Diseases Clinical Trial

— VISIONAIRE  

Official title:

A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies For Patients With Atrial Fibrillation And Severe Chronic Kidney Dysfunction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06402851
• Other study ID #: AVAP-NG 3353
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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 investigator´s opinion, may impact survival in 12 months.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrium; Fibrillation
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

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)