Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT06402851
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2024-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D001282', 'term': 'Atrial Flutter'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000925', 'term': 'Anticoagulants'}, {'id': 'C552171', 'term': 'edoxaban'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All study endpoints will be assessed by an independent Clinical Events Committee (CEC), whose members will be unaware of randomized treatment assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized in 1:1:2 to warfarin, edoxaban or no OAC, stratified by renal replacement status.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2024-05-03', 'studyFirstSubmitQcDate': '2024-05-03', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory endpoint', 'timeFrame': '12 months', 'description': 'Quality of life by EQ-5D'}, {'measure': 'Exploratory endpoint', 'timeFrame': '24 months (median follow-up)', 'description': 'Access site bleeding'}, {'measure': 'Exploratory endpoint', 'timeFrame': '24 months (median follow-up)', 'description': 'Fistula or catheter thrombosis'}, {'measure': 'Exploratory endpoint', 'timeFrame': '24 months (median follow-up)', 'description': 'Fistula or catheter failure'}], 'primaryOutcomes': [{'measure': 'Primary efficacy endpoint', 'timeFrame': '24 months (median follow-up)', 'description': 'Time to first occurrence of the composite of stroke or systemic embolism'}, {'measure': 'Primary safety endpoint:', 'timeFrame': '24 months (median follow-up)', 'description': 'Major or clinically relevant non-major bleeding according to the ISTH criteria'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy endpoints', 'timeFrame': '24 months (median follow-up)', 'description': 'Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism'}, {'measure': 'Secondary efficacy endpoints', 'timeFrame': '24 months (median follow-up)', 'description': 'Time to first occurrence of the composite of: CV death, MI, or stroke'}, {'measure': 'Secondary efficacy endpoints', 'timeFrame': '24 months (median follow-up)', 'description': 'Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke'}, {'measure': 'Secondary efficacy endpoints', 'timeFrame': '24 months (median follow-up)', 'description': 'All cause death'}, {'measure': 'Secondary safety endpoint', 'timeFrame': '24 months (median follow-up)', 'description': 'Time to first occurrence of major bleeding (ISTH)'}, {'measure': 'Secondary safety endpoint', 'timeFrame': '24 months (median follow-up)', 'description': 'Time to first occurrence of GUSTO moderate or severe bleeding'}, {'measure': 'Secondary safety endpoint', 'timeFrame': '24 months (median follow-up)', 'description': 'Time to first occurrence of TIMI minor and major bleeding'}, {'measure': 'Secondary safety endpoint', 'timeFrame': '24 months (median follow-up)', 'description': 'Fatal or intra-cranial bleeding'}, {'measure': 'Net clinical endpoint', 'timeFrame': '24 months (median follow-up)', 'description': 'Time to first occurrence of CV death, MI, stroke, systemic embolism, fatal bleeding or bleeding into a critical organ'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'atrial flutter', 'oral anticoagulation', 'dialysis'], 'conditions': ['Atrium; Fibrillation', 'Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent);\n* CHA2DS2-Vasc ≥ 2 points (≥ 3 if female);\n* 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).\n\nExclusion Criteria:\n\n* Active bleeding or severe bleeding \\< 1 month;\n* Prior kidney transplantation;\n* Refusal de provide consent\n* Severe chronic liver disease (Child C);\n* Other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism);\n* Prior intracranial hemorrhage;\n* Bleeding disorder (other than uremia);\n* Platelet count \\< 50,000 / mm3 ;\n* Pregnancy or breastfeeding;\n* Mechanical valvar prosthesis;\n* Moderate to severe mitral stenosis;\n* Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker;\n* Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.'}, 'identificationModule': {'nctId': 'NCT06402851', 'acronym': 'VISIONAIRE', 'briefTitle': 'Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sirio-Libanes'}, 'officialTitle': 'A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction', 'orgStudyIdInfo': {'id': 'AVAP-NG 3353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Warfarin', 'description': 'Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin.', 'interventionNames': ['Drug: Anticoagulant Oral']}, {'type': 'EXPERIMENTAL', 'label': 'Edoxaban', 'description': 'Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD.', 'interventionNames': ['Drug: Anticoagulant Oral']}, {'type': 'NO_INTERVENTION', 'label': 'No anticoagulation', 'description': 'No oral anticoagulation should be used'}], 'interventions': [{'name': 'Anticoagulant Oral', 'type': 'DRUG', 'otherNames': ['Edoxaban', 'Warfarin'], 'description': 'Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0.', 'armGroupLabels': ['Edoxaban', 'Warfarin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salvador', 'state': 'Estado de Bahia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Ana Nery', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'Brasília', 'state': 'Federal District', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia do DF', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'city': 'Campo Grande', 'state': 'Mato Grosso do Sul', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Universitário Maria Aparecida Pedrossian - EBSERH', 'geoPoint': {'lat': -20.44278, 'lon': -54.64639}}, {'city': 'São Paulo', 'state': 'São Paulo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Sociedade Beneficente de Senhoras Hospital Sírio-Libanês', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Bragança Paulista', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Murillo O Antunes', 'role': 'CONTACT', 'email': 'dr.murilloantunes@gmail.com', 'phone': '+55 11 2503-377'}], 'facility': 'Hospital Universitário São Francisco na Providência de Deus', 'geoPoint': {'lat': -22.9527, 'lon': -46.54418}}, {'city': 'Ponta Grossa', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Mario Cray', 'role': 'CONTACT', 'email': 'mariocraydacosta@gmail.com', 'phone': '+55 42 3028-9494'}], 'facility': 'Santa Casa de Misericórdia de Ponta Grossa', 'geoPoint': {'lat': -25.095, 'lon': -50.16194}}], 'centralContacts': [{'name': 'Lilian Barbosa, MBA', 'role': 'CONTACT', 'email': 'lilian@bcri.org.br', 'phone': '+55 11 98966 0550'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sirio-Libanes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}