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

Description

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

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Study Overview

Study Details

Study overview

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

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

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

Condition
Ischemic Stroke; Ischemic Attack, Transient
Intervention / Treatment

-

Contacts and Locations

Mesa

Banner Desert Medical Center, Mesa, Arizona, United States, 85202

Tucson

University of Arizona, Tucson, Arizona, United States, 85721

Fayetteville

Plaza Neuroscience Clinic, Fayetteville, Arkansas, United States, 72703-3902

Berkeley

Alta Bates Medical Center Cancer Center, Berkeley, California, United States, 94705

Burbank

Providence Saint Joseph Medical Center - Cancer Center, Burbank, California, United States, 91505

Burlingame

Mills Peninsula Health Services, Burlingame, California, United States, 94010

Castro Valley

Sutter Health - Eden Medical Center, Castro Valley, California, United States, 94546

Glendale

Glendale Adventist Medical Center, Glendale, California, United States, 91206

Irvine

UC Irvine Healthcare Center, Irvine, California, United States, 92697

La Mesa

Sharp Grossmont Hospital, La Mesa, California, United States, 91942

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2026-12-09