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

Clinical Trial Title

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

National Clinical Trial Number:

NCT05702034

Contact Information

Clinical Trial Protocol Description:

The purpose of this study is to see if an experimental drug, called milvexian in addition to standard of care, is safe and useful in reducing the risk of future ischemic stroke in subjects after ischemic stroke or transient ischemic attack compared to placebo (tablet with no active drug) in addition to standard of care. An experimental drug is one that is not approved by the United States Food and Drug Administration (FDA).

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following 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.

You will be excluded from the study if any of the following criteria apply to you:

  • 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.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Arooshi Kumar, MD

Contact Information

Henna McCoy

Clinical Trial Location

Rush University Medical Center

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

Get Directions

Clinical Trial FAQs

Find out if a clinical trial makes sense for you.

Learn more
Learn more