Multiple Sclerosis Clinical Trial

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

Summary

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

View Eligibility Criteria

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 (<=) 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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

15000

Study ID:

NCT05702034

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 576 Locations for this study

See Locations Near You

Glendale Adventist Medical Center
Glendale California, 91206, United States
Long Beach Memorial
Long Beach California, 90806, United States
Harbor Ucla Medical Center
Torrance California, 90502, United States
Insight Hospital and Medical Center Chicago
Chicago Illinois, 60616, United States
Prairie Education & Research Cooperative
Springfield Illinois, 62769, United States
Sinai Hospital of Baltimore
Baltimore Maryland, 21215, United States
Comprehensive Neurology Services
Silver Spring Maryland, 20902, United States
Detroit Clinical Research Center
Farmington Hills Michigan, 48334, United States
Memorial Institute for Neurosciences and Multiple Sclerosis
Owosso Michigan, 48867, United States
University of Nebraska Medical Center
Omaha Nebraska, 68106, United States
Lincoln Hospital
Bronx New York, 10451, United States
Weill Cornell Medical College
New York New York, 10021, United States
Guilford Neurologic Associates
Greensboro North Carolina, 27405, United States
Ascension Medical Group - St. John Clinic Infectious Disease
Tulsa Oklahoma, 74104, United States
Temple University Hospital
Philadelphia Pennsylvania, 19140, United States
Einstein Medical Center
Philadelphia Pennsylvania, 19141, United States
Neurology Consultants of Dallas, PA
Dallas Texas, 75231, United States
Sentara Medical Group
Norfolk Virginia, 23502, United States
Winchester Medical Center
Winchester Virginia, 22601, United States
Saiseikai Fukuoka General Hospital
Fukuoka , 810-0, Japan
Fukuoka Tokushukai Hospital
Kasuga-shi , 816-0, Japan
National Hospital Organization Fukuoka Higashi Medical Center
Koga , 811-3, Japan

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

15000

Study ID:

NCT05702034

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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