A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
Ischemic Stroke; Ischemic Attack, TransientThe purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
40 and up
Critères de participation
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
Lieu de l'étude
University of Alberta Hospital
University of Alberta HospitalEdmonton, Alberta
Canada
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Vancouver General Hospital
Vancouver General HospitalVancouver, British Columbia
Canada
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Kingston Health Sciences Centre
Kingston Health Sciences CentreKingston, Ontario
Canada
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CHU de Quebec - Hôpital de l' Enfant Jésus
CHU de Quebec - Hôpital de l' Enfant JésusQuébec, Quebec
Canada
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Medicine Hat Regional Hospital - Medical Arts Clinic
Medicine Hat Regional Hospital - Medical Arts ClinicMedicine Hat, Alberta
Canada
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University of Calgary
University of CalgaryCalgary, Alberta
Canada
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Health Sciences Centre Winnipeg
Health Sciences Centre WinnipegWinnipeg, Manitoba
Canada
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Royal Columbian Hospital
Royal Columbian HospitalNew Westminster, British Columbia
Canada
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Health Sciences North
Health Sciences NorthSudbury, Ontario
Canada
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QEII Health Sciences Centre
QEII Health Sciences CentreHalifax, Nova Scotia
Canada
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CISSS de la Monteregie Centre
CISSS de la Monteregie CentreGreenfield Park, Quebec
Canada
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Lethbridge Regional Hospital
Lethbridge Regional HospitalLethbridge, Alberta
Canada
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Brandon Regional Health Centre
Brandon Regional Health CentreBrandon, Manitoba
Canada
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Niagara Health System - Greater Niagara General Site
Niagara Health System - Greater Niagara General SiteNiagara Falls, Ontario
Canada
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CHUS
CHUSSherbrooke, Quebec
Canada
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- Étude parrainée par
- Janssen Research & Development, LLC
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05702034