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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Ischemic Stroke; Ischemic Attack, Transient

In brief

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

Key facts

Study ID

NCT05702034

Run by

Janssen Research & Development, LLC

People needed

12532

Starts

2023-02-15

Expected to finish

2026-12-09

Last updated by the study team

2026-07-31

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Chaim Sheba Medical Center — Ramat Gan, Israel
• Ziv Medical Center — Safed, Israel
• Chugoku Rosai Hospital — Kure, Japan
• Shinkoga Clinic — Kurume-shi, Japan
• Koseikai Takeda Hospital — Kyoto, Japan
• Kyoto University Hospital — Kyoto, Japan
• Maebashi Red Cross Hospital — Maebashi, Japan
• Matsubara Tokushukai Hospital — Matsubara-shi, Japan
• Rotorua Hospital — Rotorua, New Zealand
• Tauranga Hospital — Tauranga, New Zealand
• Wellington Hospital — Wellington, New Zealand
• Banner Desert Medical Center — Mesa, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Plaza Neuroscience Clinic — Fayetteville, Arkansas, United States
• Alta Bates Medical Center Cancer Center — Berkeley, California, United States
• Providence Saint Joseph Medical Center - Cancer Center — Burbank, California, United States
• Mills Peninsula Health Services — Burlingame, California, United States
• Sutter Health - Eden Medical Center — Castro Valley, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• UC Irvine Healthcare Center — Irvine, California, United States
• Sharp Grossmont Hospital — La Mesa, California, United States
• Long Beach Memorial — Long Beach, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Universitaetsklinikum Essen — Essen, Germany

Full record on ClinicalTrials.gov

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