Last updated 15 days ago
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
15000 patients around the world
Available in Argentina, Chile, Mexico, United States, Brazil, Spain
Janssen Research & Development, LLC
21Research sites
15000Patients around the world
This study is for people with
Stroke
Ischemic stroke
Requirements for the patient
From 40 Years
All Gender
Medical requirements
- 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 (>=) 6Participants 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-careA 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 interventionWilling 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 treatmentThe index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulationThe 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 investigationsIncreased 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 hemorrhageCurrent active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitisKnown allergies, hypersensitivity, or intolerance to milvexian or its excipients
Sites
Sanatorio Duarte Quiros - Córdoba
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Fundación Sanatorio Güemes - CABA, Buenos Aires
Recruiting
Clínica Mayo de UMCB SRL
Recruiting
Hospital Córdoba
Recruiting
Clínica Privada Vélez Sarsfield - Córdoba
Recruiting
Sanatorio Allende (Nueva Córdoba)
Recruiting
Nuevo Hospital San Roque - Córdoba
Recruiting
Sanatorio de la Cañada - Córdoba
Recruiting
StudyLIBREXIASTROKE
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Ischemic strokeStroke
Requirements
From 40 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05702034
