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

February 19, 2025 updated by: Hospital Sirio-Libanes

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • Braganca Paulista, Brazil
        • Recruiting
        • Hospital Universitário São Francisco na Providência de Deus
        • Contact:
      • Ponta Grossa, Brazil
        • Recruiting
        • Santa Casa de Misericordia de Ponta Grossa
        • Contact:
    • BA
      • Salvador, BA, Brazil
        • Active, not recruiting
        • Hospital Ana Nery
    • DF
      • Brasilia, DF, Brazil
        • Active, not recruiting
        • Instituto de Cardiologia do DF
    • MS
      • Campo Grande, MS, Brazil
        • Active, not recruiting
        • Hospital Universitário Maria Aparecida Pedrossian - EBSERH
    • São Paulo
      • Sao Paulo, São Paulo, Brazil
        • Active, not recruiting
        • Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No anticoagulation
No oral anticoagulation should be used
Active Comparator: Warfarin
Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin.
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.
Other Names:
  • Edoxaban
  • Warfarin
Experimental: Edoxaban
Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD.
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.
Other Names:
  • Edoxaban
  • Warfarin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary efficacy endpoint
Time Frame: 24 months (median follow-up)
Time to first occurrence of the composite of stroke or systemic embolism
24 months (median follow-up)
Primary safety endpoint:
Time Frame: 24 months (median follow-up)
Major or clinically relevant non-major bleeding according to the ISTH criteria
24 months (median follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 months (median follow-up)
Secondary efficacy endpoints
Time Frame: 24 months (median follow-up)
Time to first occurrence of the composite of: CV death, MI, or stroke
24 months (median follow-up)
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
24 months (median follow-up)
Secondary efficacy endpoints
Time Frame: 24 months (median follow-up)
All cause death
24 months (median follow-up)
Secondary safety endpoint
Time Frame: 24 months (median follow-up)
Time to first occurrence of major bleeding (ISTH)
24 months (median follow-up)
Secondary safety endpoint
Time Frame: 24 months (median follow-up)
Time to first occurrence of GUSTO moderate or severe bleeding
24 months (median follow-up)
Secondary safety endpoint
Time Frame: 24 months (median follow-up)
Time to first occurrence of TIMI minor and major bleeding
24 months (median follow-up)
Secondary safety endpoint
Time Frame: 24 months (median follow-up)
Fatal or intra-cranial bleeding
24 months (median follow-up)
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
24 months (median follow-up)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory endpoint
Time Frame: 12 months
Quality of life by EQ-5D
12 months
Exploratory endpoint
Time Frame: 24 months (median follow-up)
Access site bleeding
24 months (median follow-up)
Exploratory endpoint
Time Frame: 24 months (median follow-up)
Fistula or catheter thrombosis
24 months (median follow-up)
Exploratory endpoint
Time Frame: 24 months (median follow-up)
Fistula or catheter failure
24 months (median follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Sirio-Libanes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AVAP-NG 3353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After publication of study primary results in a peer-reviewed scientific medical journal, interested parts in data sharing are welcome to contact the corresponding author directly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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