Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-30 @ 6:56 AM
Study NCT ID:
NCT05757869
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hong Kong', 'Mexico', 'Thailand', 'Vietnam']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720754', 'term': 'milvexian'}, {'id': 'C522181', 'term': 'apixaban'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20283}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism', 'timeFrame': 'Up to 4 years', 'description': 'Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.'}], 'secondaryOutcomes': [{'measure': 'Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding', 'timeFrame': 'Up to 4 years', 'description': 'Time to the first occurrence of ISTH major bleeding will be reported.'}, {'measure': 'Time to the First Occurrence of the Composite of ISTH Major and Clinically Relevant Non-major (CRNM) Bleeding', 'timeFrame': 'Up to 4 years', 'description': 'Time to the first occurrence of the composite of ISTH major and CRNM bleeding will be reported.'}, {'measure': 'Time to the First Occurrence of Composite Endpoint of Stroke, Non-CNS Systemic Embolism and ISTH Major Bleeding', 'timeFrame': 'Up to 4 years', 'description': 'Time to the first occurrence of composite endpoint of stroke, non-CNS systemic embolism and ISTH major bleeding will be reported.'}, {'measure': 'Time to the First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, and Non-CNS Systemic Embolism', 'timeFrame': 'Up to 4 years', 'description': 'Time to the first occurrence of composite endpoint of CV death, MI, stroke, and non-CNS systemic embolism will be reported.'}, {'measure': 'Time to CV Death', 'timeFrame': 'Up to 4 years', 'description': 'Time to CV death will be reported.'}, {'measure': 'Time to the First Occurrence of Composite Endpoint of All-cause Death, MI, Stroke and Non-CNS Systemic Embolism', 'timeFrame': 'Up to 4 years', 'description': 'Time to the first occurrence of composite endpoint of all-cause death, MI, stroke and Non-CNS systemic embolism will be reported.'}, {'measure': 'Time to the First Occurrence of Composite Endpoint of CV Death, MI, Stroke, Acute Limb Ischemia (ALI), and Urgent Hospitalization for Vascular cause of Ischemic Nature', 'timeFrame': 'Up to 4 years', 'description': 'Time to the first occurrence of composite endpoint of CV death, MI, stroke, ALI \\[any unanticipated revascularization or amputation of ischemic limb\\]), and urgent hospitalization for vascular cause of ischemic nature (including deep vein thrombosis \\[DVT\\] and pulmonary embolism \\[PE\\]) will be reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '39214801', 'type': 'DERIVED', 'citation': 'Jain SS, Mahaffey KW, Pieper KS, Shimizu W, Potpara T, Ruff CT, Kamel H, Lewis BS, Cornel JH, Kowey PR, Horrow J, Strony J, Plotnikov AN, Li D, Weng S, Donahue J, Gibson CM, Steg PG, Mehran R, Weitz JI, Johnston SC, Hankey GJ, Harrington RA, Lam CSP; LIBREXIA AF Trial Investigators and Committees. Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design. Am Heart J. 2024 Nov;277:145-158. doi: 10.1016/j.ahj.2024.08.011. Epub 2024 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age of 18 years\n* Medically stable and appropriate for chronic antithrombotic treatment\n* Atrial fibrillation eligible to receive anticoagulation\n* Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure\n\nExclusion Criteria:\n\n* Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study\n* Any condition other than AF that requires chronic anticoagulation'}, 'identificationModule': {'nctId': 'NCT05757869', 'acronym': 'LIBREXIA-AF', 'briefTitle': 'A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CR109220'}, 'secondaryIdInfos': [{'id': '70033093AFL3002', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2022-501419-15-00', 'type': 'REGISTRY', 'domain': 'EUCT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Milvexian', 'description': 'Participants will receive milvexian 100 milligrams (mg) orally, twice daily and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply.', 'interventionNames': ['Drug: Milvexian', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Apixaban', 'description': 'Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply.', 'interventionNames': ['Drug: Apixaban', 'Drug: Apixaban Placebo']}], 'interventions': [{'name': 'Milvexian', 'type': 'DRUG', 'description': 'Milvexian will be administered orally.', 'armGroupLabels': ['Milvexian']}, {'name': 'Apixaban', 'type': 'DRUG', 'description': 'Apixaban will be administered orally.', 'armGroupLabels': ['Apixaban']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Milvexian matching milvexian placebo will be administered orally.', 'armGroupLabels': ['Milvexian']}, {'name': 'Apixaban Placebo', 'type': 'DRUG', 'description': 'Apixaban matching apixaban placebo will be administered orally.', 'armGroupLabels': ['Apixaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35010', 'city': 'Alexander City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Advanced 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