Atrium; FibrillationPhase 4VISIONAIRENCT06402851
Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
A Phase 4 study testing Anticoagulant Oral in people with Atrium; Fibrillation and Chronic Kidney Diseases, run by Hospital Sirio-Libanes at 6 sites in Brazil.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrium; Fibrillation, Chronic Kidney Diseases
- What is being tested?
- Anticoagulant Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 6 sitesBrazil
- Study dates
- 18 Dec 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Brazil6 sites, 2 recruiting
- Recruiting
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista
Murillo O Antunes, +55 11 2503-377, dr.murilloantunes@gmail.com
- Active, not recruiting
Instituto de Cardiologia do DF
Brasília, Federal District
- Active, not recruiting
Hospital Universitário Maria Aparecida Pedrossian - EBSERH
Campo Grande, Mato Grosso do Sul
- Recruiting
Santa Casa de Misericórdia de Ponta Grossa
Ponta Grossa
Mario Cray, +55 42 3028-9494, mariocraydacosta@gmail.com
- Active, not recruiting
Hospital Ana Nery
Salvador, Estado de Bahia
- Active, not recruiting
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo, São Paulo
About this study
Official 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
- Conditions
- Atrium; Fibrillation, Chronic Kidney Diseases
- Being tested
- Anticoagulant Oral
- Keywords
- atrial fibrillation, atrial flutter, oral anticoagulation, dialysis
- Medical subject headings
- Atrial Fibrillation, Renal Insufficiency, Chronic, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulant OralDrug
Also called Edoxaban, Warfarin
Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Active comparator | Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin. Receives: Drug: Anticoagulant Oral |
| Edoxaban | Experimental | Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD. Receives: Drug: Anticoagulant Oral |
| No anticoagulation | No intervention | No oral anticoagulation should be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
Time to first occurrence of the composite of stroke or systemic embolism
Measured: 24 months (median follow-up)
Primary safety endpoint:
Major or clinically relevant non-major bleeding according to the ISTH criteria
Measured: 24 months (median follow-up)
Secondary outcomes (9)
Secondary efficacy endpoints
Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism
Measured: 24 months (median follow-up)
Secondary efficacy endpoints
Time to first occurrence of the composite of: CV death, MI, or stroke
Measured: 24 months (median follow-up)
Secondary efficacy endpoints
Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke
Measured: 24 months (median follow-up)
Secondary efficacy endpoints
All cause death
Measured: 24 months (median follow-up)
Secondary safety endpoint
Time to first occurrence of major bleeding (ISTH)
Measured: 24 months (median follow-up)
Secondary safety endpoint
Time to first occurrence of GUSTO moderate or severe bleeding
Measured: 24 months (median follow-up)
Secondary safety endpoint
Time to first occurrence of TIMI minor and major bleeding
Measured: 24 months (median follow-up)
Secondary safety endpoint
Fatal or intra-cranial bleeding
Measured: 24 months (median follow-up)
Net clinical endpoint
Time to first occurrence of CV death, MI, stroke, systemic embolism, fatal bleeding or bleeding into a critical organ
Measured: 24 months (median follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start18 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrium; FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in 1:1:2 to warfarin, edoxaban or no OAC, stratified by renal replacement status.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402851
- Sponsor's protocol ID
- AVAP-NG 3353
- Acronym
- VISIONAIRE
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction
- ClinicalTrials.gov ID
- NCT06402851
- Acronym / sponsor ID
- VISIONAIRE / AVAP-NG 3353
- Conditions
- Atrium; Fibrillation, Chronic Kidney Diseases
- Keywords
- atrial fibrillation, atrial flutter, oral anticoagulation, dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Collaborators
- Daiichi Sankyo
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized in 1:1:2 to warfarin, edoxaban or no OAC, stratified by renal replacement status.
| Arm | Type | Receives |
|---|---|---|
| Warfarin | Active comparator | Drug: Anticoagulant OralFull-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin. |
| Edoxaban | Experimental | Drug: Anticoagulant OralDose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD. |
| No anticoagulation | No intervention | –No oral anticoagulation should be used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulant OralAlso: Edoxaban, WarfarinPatients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0. | Drug | Edoxaban, Warfarin |
Primary outcome
Primary efficacy endpoint
Time frame: 24 months (median follow-up)
Time to first occurrence of the composite of stroke or systemic embolism
Primary safety endpoint:
Time frame: 24 months (median follow-up)
Major or clinically relevant non-major bleeding according to the ISTH criteria
9 secondary outcomes
Secondary efficacy endpoints
Time frame: 24 months (median follow-up)
Secondary efficacy endpoints
Time frame: 24 months (median follow-up)
Secondary efficacy endpoints
Time frame: 24 months (median follow-up)
Secondary efficacy endpoints
Time frame: 24 months (median follow-up)
Secondary safety endpoint
Time frame: 24 months (median follow-up)
Secondary safety endpoint
Time frame: 24 months (median follow-up)
Secondary safety endpoint
Time frame: 24 months (median follow-up)
Secondary safety endpoint
Time frame: 24 months (median follow-up)
Net clinical endpoint
Time frame: 24 months (median follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anticoagulant Oral in people with Atrium; Fibrillation and Chronic Kidney Diseases, run by Hospital Sirio-Libanes at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lilian Barbosa, MBA (+55 11 98966 0550, lilian@bcri.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint (time frame: 24 months (median follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.