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NCT Number: NCT06402851

Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)

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

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anticoagulant Oral

Drug

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

Other names: Edoxaban, Warfarin

Primary outcomes

  1. Primary efficacy endpoint

    Time frame: 24 months (median follow-up)

    Time to first occurrence of the composite of stroke or systemic embolism

  2. Primary safety endpoint:

    Time frame: 24 months (median follow-up)

    Major or clinically relevant non-major bleeding according to the ISTH criteria

Secondary outcomes

  1. Secondary efficacy endpoints

    Time frame: 24 months (median follow-up)

    Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism

  2. Secondary efficacy endpoints

    Time frame: 24 months (median follow-up)

    Time to first occurrence of the composite of: CV death, MI, or stroke

  3. Secondary efficacy endpoints

    Time frame: 24 months (median follow-up)

    Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke

  4. Secondary efficacy endpoints

    Time frame: 24 months (median follow-up)

    All cause death

  5. Secondary safety endpoint

    Time frame: 24 months (median follow-up)

    Time to first occurrence of major bleeding (ISTH)

  6. Secondary safety endpoint

    Time frame: 24 months (median follow-up)

    Time to first occurrence of GUSTO moderate or severe bleeding

  7. Secondary safety endpoint

    Time frame: 24 months (median follow-up)

    Time to first occurrence of TIMI minor and major bleeding

  8. Secondary safety endpoint

    Time frame: 24 months (median follow-up)

    Fatal or intra-cranial bleeding

  9. Net clinical endpoint

    Time frame: 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 outcomes

  1. Exploratory endpoint

    Time frame: 12 months

    Quality of life by EQ-5D

  2. Exploratory endpoint

    Time frame: 24 months (median follow-up)

    Access site bleeding

  3. Exploratory endpoint

    Time frame: 24 months (median follow-up)

    Fistula or catheter thrombosis

  4. Exploratory endpoint

    Time frame: 24 months (median follow-up)

    Fistula or catheter failure

Study contacts

Contact information is provided by the study sponsor or research team.

Lilian Barbosa, MBA

CONTACT

[email protected]

+55 11 98966 0550

Sponsors and collaborators

Lead sponsor

Hospital Sirio-Libanes

Other

Collaborators

  • Daiichi Sankyo

Registry information

Official study title

A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction

Acronym: VISIONAIRE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 7, 2024
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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