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Active Not Recruiting NCT05702034

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

Conditions: Ischemic Stroke; Ischemic Attack, Transient

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 12532
Sponsor: Janssen Research & Development, LLC

Location: Banner Desert Medical Center Mesa Arizona

Summary

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

Eligibility Criteria

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 (\=) 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05702034). StuddyBuddy aggregates publicly available trial information.