> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-milvexian-in-participants-after-a-recent-acute-0b485d43-2b27-4d92-b8a0-1716a132b945 > Record changed: 2026-10-13 # A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome NCT05754957 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) Participants 14,194 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) Start date 2023-04-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) Number of sites 1,003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Title and summary **Summary** The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular \\\[CV\\\] death, myocardial infarction \\\[MI\\\], and ischemic stroke). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Acronym** LIBREXIA-ACS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Short title** A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Official title** A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Dates **Completion date** 2026-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **First posted** 2023-03-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Registry last updated** 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Primary completion date** 2026-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Start date** 2023-04-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Size and sites **Actual participants** 14,194 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Participants** 14,194 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Number of sites** 1,003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Identifiers **Registry ID** NCT05754957 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **ClinicalTrials.gov ID** NCT05754957 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Outcomes ### Primary outcomes 1. Time to First Occurrence of Major Adverse Cardiovascular Event (MACE) Timeframe: Up to 3 years 6 months Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke. ### Secondary outcomes 1. Time to the First Occurrence of Major Adverse Vascular Event (MAVE) Timeframe: Up to 3 years 6 months Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of CV death, MI, ischemic stroke, major adverse limb event (MALE), and symptomatic venous thromboembolism (VTE). 2. Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke Timeframe: Up to 3 years 6 months Time to the first occurrence of composite of ACM, MI and ischemic stroke will be reported. 3. Time to Cardiovascular (CV) Death Timeframe: Up to 3 years 6 months Time to CV death will be reported. 4. Time to All-cause Mortality (ACM) Timeframe: Up to 3 years 6 months Time to ACM will reported. ACM will be categorized into CV death, non-CV death, and death due to unknown cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction \[STEMI\], non-STEMI, or unstable angina \[UA\]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB \[CK-MB\]) above the upper limit of normal as determined by the local laboratory - Participants must have at least 2 of the following risk factors:a) age 65 or older, b) diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis, intracranial artery stenosis, g) conservative management (that is, no percutaneous intervention \[PCI\] or CABG after index ACS event), h) Any one or more of the following high-risk angiographic features i) total stent length of greater than (>) 30 millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with more than one stent, iv) calcified target lesion treated with atherectomy, v) treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI) - All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening - A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention ### Exclusion criteria - MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event - Planned CABG or staged PCI after randomization - Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines - Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Sites - Advanced Cardiovascular, LLCAlexander City, United States - SORRA ResearchBirmingham, United States - Ascension St. Vincent's Health SystemBirmingham, United States - IMC-Diagnostic and Medical ClinicMobile, United States - Cardiology Associates of Mobile IncMobile, United States - Mercy Gilbert Medical CenterGilbert, United States - Valleywise Health Medical CenterPhoenix, United States - HonorHealth NeurologyScottsdale, United States - Arkansas Heart HospitalLittle Rock, United States - Bakersfield Memorial HospitalBakersfield, United States - Mission Cardiovascular Research InstituteFremont, United States - Radin Cardiovascular Medical GroupNewport Beach, United States - Valley Clinical Trials, Inc.Northridge, United States - Stanford University School of MedicinePalo Alto, United States - VA Palo Alto Healthcare SystemPalo Alto, United States - Huntington HospitalPasadena, United States - The Cardiovascular CenterRedding, United States - University Of California San DiegoSan Diego, United States - San Diego Cardiac CenterSan Diego, United States - VA San Diego Health Care SystemSan Diego, United States - UCLASanta Monica, United States - NorthBay Clinical Research, LLCSanta Rosa, United States - Ramin Manshadi, MDStockton, United States - South Denver Cardiology Associates PCLittleton, United States - Nuvance Health Medical Practices Cardiology DanburyDanbury, United States And 978 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## References - PubMed 39986336 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39986336/) Related publication ### Other registry identifiers (2) - 2022-501418-69-00 - 70033093ACS3003 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05754957) ## Related records ### Drugs (1) - [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) - [Acute coronary syndrome](https://trialight.com/data/condition/acute-coronary-syndrome-3d7c2c1f-86ca-5a25-913a-6f9a7e95f989.md) Primary condition ### Targets (1) - [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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