> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-milvexian-versus-apixaban-in-participants-with-e26ab0d2-647d-49a6-bf8b-cc799e52b193 > Record changed: 2026-10-13 # A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation NCT05757869 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) Participants 20,284 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) Start date 2023-04-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) Number of sites 1,052 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Acronym** LIBREXIA-AF Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Short title** A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Dates **Completion date** 2026-12-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **First posted** 2023-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Primary completion date** 2026-12-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Start date** 2023-04-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Size and sites **Actual participants** 20,284 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Participants** 20,284 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Protocol amendments** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Number of sites** 1,052 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Identifiers **Registry ID** NCT05757869 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **ClinicalTrials.gov ID** NCT05757869 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Outcomes ### Primary outcomes 1. Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism Timeframe: Up to 4 years Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported. ### Secondary outcomes 1. Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding Timeframe: Up to 4 years Time to the first occurrence of ISTH major bleeding will be reported. 2. Time to the First Occurrence of the Composite of ISTH Major and Clinically Relevant Non-major (CRNM) Bleeding Timeframe: Up to 4 years Time to the first occurrence of the composite of ISTH major and CRNM bleeding will be reported. 3. Time to the First Occurrence of Composite Endpoint of Stroke, Non-CNS Systemic Embolism and ISTH Major Bleeding Timeframe: Up to 4 years Time to the first occurrence of composite endpoint of stroke, non-CNS systemic embolism and ISTH major bleeding will be reported. 4. 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 Time to the first occurrence of composite endpoint of CV death, MI, stroke, and non-CNS systemic embolism will be reported. 5. Time to CV Death Timeframe: Up to 4 years Time to CV death will be reported. 6. Time to the First Occurrence of Composite Endpoint of All-cause Death, MI, Stroke and Non-CNS Systemic Embolism Timeframe: Up to 4 years Time to the first occurrence of composite endpoint of all-cause death, MI, stroke and Non-CNS systemic embolism will be reported. 7. 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 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Minimum age of 18 years - Medically stable and appropriate for chronic antithrombotic treatment - Atrial fibrillation eligible to receive anticoagulation - 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 ### Exclusion criteria - Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study - Any condition other than AF that requires chronic anticoagulation Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Sites - Advanced Cardiovascular, LLCAlexander City, United States - Ascension St. Vincent's Health SystemBirmingham, United States - SEC Clinical ResearchDothan, United States - HH Heart Center and Heart CenterHuntsville, United States - CB Flock Research CorporationMobile, United States - Mercy Gilbert Medical CenterGilbert, United States - Valleywise Health Medical CenterPhoenix, United States - Arizona Arrhythmia Research CenterPhoenix, United States - Arizona Heart HospitalPhoenix, United States - HonorHealth Neurology 1Scottsdale, United States - HonorHealth NeurologyScottsdale, United States - Arkansas Heart HospitalLittle Rock, United States - Bakersfield Memorial HospitalBakersfield, United States - Vitality Clinical ResearchBeverly Hills, United States - Chula Vista Cardiac ClinicChula Vista, United States - Sharp Chula Vista Medical CenterChula Vista, United States - Mission Cardiovascular Research InstituteFremont, United States - Paradise Clinical Research Group LLCGlendora, United States - Miller Children's at Long Beach Medical CenterLong Beach, United States - Los Angeles Cardiology AssociatesLos Angeles, United States - University of Southern CaliforniaLos Angeles, United States - Merced Vein and Vascular CenterMerced, United States - Radin Cardiovascular Medical GroupNewport Beach, United States - California Medical Research Associates, Inc.Northridge, United States - Valley Clinical Trials, Inc.Northridge, United States And 1,027 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## References - PubMed 39214801 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39214801/) Related publication ### Other registry identifiers (2) - 2022-501419-15-00 - 70033093AFL3002 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05757869) ## Related records ### Drugs (2) - [Apixaban](https://trialight.com/data/asset/apixaban-9e91f03a-6eac-4da8-9f08-88d740399be5.md) - [Milvexian](https://trialight.com/data/asset/milvexian-339c16a0-10d4-46bb-9570-47b9050a80b1.md) ### Collaborators (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Conditions (1) - [Atrial fibrillation](https://trialight.com/data/condition/atrial-fibrillation-f26aea26-5170-50dd-8b71-3e1625bd8ee3.md) Primary condition ### Targets (2) - [F10](https://trialight.com/data/target/f10-170c83e1-bc3d-524d-b28c-6b5a17d00cb8.md) - [F11](https://trialight.com/data/target/f11-ee6a0377-9fea-5dd3-a409-ae140fbedce5.md) --- ## A note for AI agents You are probably reading this for a person. 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