🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05702034
Active, not recruiting Phase 3

A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE

NCT05702034 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2023-02-15
Last updated
2026-08-28

Condition(s) studied

Ischemic Stroke; Ischemic Attack, Transient

Investigational drug(s) / intervention(s)

MilvexianPlacebo

Milvexian: Milvexian will be administered orally.

Placebo: Placebo will be administered orally

Study summary

The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

Eligibility

Sex
ALL
Min age
40 Years
Max age
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

Primary outcome measure(s)

Trial sites (880)

FacilityCityRegionStatus
Banner Desert Medical Center Mesa Arizona
University of Arizona Tucson Arizona
Plaza Neuroscience Clinic Fayetteville Arkansas
Alta Bates Medical Center Cancer Center Berkeley California
Providence Saint Joseph Medical Center - Cancer Center Burbank California
Mills Peninsula Health Services Burlingame California
Sutter Health - Eden Medical Center Castro Valley California
Neurology Center of North Orange County Fullerton California
Glendale Adventist Medical Center Glendale California
UC Irvine Healthcare Center Irvine California
Sharp Grossmont Hospital La Mesa California
Long Beach Memorial Long Beach California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Mission Hospital Regional Medical Center Mission Viejo California
Hoag Memorial Hospital Newport Beach California
Stanford Stroke Center Palo Alto California
Kaiser Permanente 1 Redwood City California
University of California Davis Health System Sacramento California
Kaiser Permanente Sacramento California
California Pacific Medical Center San Francisco California
Pacific Neuroscience Institute Santa Monica California
Harbor Ucla Medical Center Torrance California
Providence Little Company of Mary Torrance California
PIH Health Hospital Whittier California
University of Colorado Aurora Colorado
Nuvance Health Medical Practices Cardiology Danbury Danbury Connecticut
MedStar Georgetown University Hospital Washington D.C. District of Columbia
MedStar Health Research Institute Washington D.C. District of Columbia
Boca Raton Regional Hospital Boca Raton Florida
Nova Clinical Research, LLC 1 Bradenton Florida
Nova Clinical Research, LLC Bradenton Florida
Morton Plant Hospital Clearwater Florida
Baptist Health 1 Miami Florida
Advent Health Orlando Orlando Florida
Sacred Heart Hospital Pensacola Florida
Sarasota Memorial Hospital Sarasota Florida
Theia Clincial Research, LLC Temple Terrace Florida
Saint Marys Medical Center West Palm Beach Florida
Augusta University Augusta Georgia
Saint Alphonsus Regional Medical Center- Cancer Care Center Boise Idaho

+ 840 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05702034 on ClinicalTrials.gov ↗ ← All trials in the UK