> 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-an-acute-ischemic-ef73fb8c-7882-4291-a1aa-bb4cc7f9d2a3 > Record changed: 2026-10-13 # A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE NCT05702034 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) Participants 12,523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) Start date 2023-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) Number of sites 880 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## Title and summary **Summary** The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Acronym** LIBREXIA-STROK Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Short title** A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Official title** A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## Dates **Completion date** 2026-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **First posted** 2023-01-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Primary completion date** 2026-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Start date** 2023-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## Size and sites **Actual participants** 12,523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Participants** 12,523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Number of sites** 880 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## Identifiers **Registry ID** NCT05702034 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **ClinicalTrials.gov ID** NCT05702034 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## 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/NCT05702034) ## Outcomes ### Primary outcomes 1. Time to First Occurrence of Ischemic Stroke Timeframe: Up to global targeted endpoint date (approximately 41 months) Time to first occurrence of ischemic stroke will be reported. ### Secondary outcomes 1. Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke Timeframe: Up to global targeted endpoint date (approximately 41 months) Time to first occurrence of any component of the composite of CVD, MI, or ischemic stroke will be reported. 2. Time to First Occurrence of Ischemic Stroke Timeframe: Up to Day 90 Time to first occurrence of ischemic stroke in the first 90 days will be reported. 3. Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE) Timeframe: Up to global targeted endpoint date (approximately 41 months) Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of (CVD), myocardial infarction (MI), ischemic stroke, major adverse limb events (MALE), symptomatic pulmonary embolism (PE) or deep vein thrombosis (DVT). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Healthy volunteers** No ### Inclusion criteria - Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (>=) 6 - Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event. - Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care - A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention - Willing and able to adhere to the lifestyle restrictions specified in this protocol ### Exclusion criteria - Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (>) 1 year prior with adequate treatment - The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation - The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial \[TOAST\] Other Determined Etiology), based on local standard-of-care investigations - Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage - Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis - Known allergies, hypersensitivity, or intolerance to milvexian or its excipients Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## Sites - Banner Desert Medical CenterMesa, United States - University of ArizonaTucson, United States - Plaza Neuroscience ClinicFayetteville, United States - Alta Bates Medical Center Cancer CenterBerkeley, United States - Providence Saint Joseph Medical Center - Cancer CenterBurbank, United States - Mills Peninsula Health ServicesBurlingame, United States - Sutter Health - Eden Medical CenterCastro Valley, United States - Neurology Center of North Orange CountyFullerton, United States - Glendale Adventist Medical CenterGlendale, United States - UC Irvine Healthcare CenterIrvine, United States - Sharp Grossmont HospitalLa Mesa, United States - Long Beach MemorialLong Beach, United States - Kaiser Permanente Los Angeles Medical CenterLos Angeles, United States - Mission Hospital Regional Medical CenterMission Viejo, United States - Hoag Memorial HospitalNewport Beach, United States - Stanford Stroke CenterPalo Alto, United States - Kaiser Permanente 1Redwood City, United States - University of California Davis Health SystemSacramento, United States - Kaiser PermanenteSacramento, United States - California Pacific Medical CenterSan Francisco, United States - Pacific Neuroscience InstituteSanta Monica, United States - Harbor Ucla Medical CenterTorrance, United States - Providence Little Company of MaryTorrance, United States - PIH Health HospitalWhittier, United States - University of ColoradoAurora, United States And 855 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## References - PubMed 41791675 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41791675/) Related publication ### Other registry identifiers (2) - 2022-501176-26-00 - 70033093STR3001 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702034) ## 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) - [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.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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