The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Time to First Occurrence of Ischemic Stroke — Up to global targeted endpoint date (approximately 41 months) Time to first occurrence of ischemic stroke will be reported.
Trial sites (880)
Facility
City
Region
Status
Banner Desert Medical Center
Mesa
Arizona
University of Arizona
Tucson
Arizona
Plaza Neuroscience Clinic
Fayetteville
Arkansas
Alta Bates Medical Center Cancer Center
Berkeley
California
Providence Saint Joseph Medical Center - Cancer Center
Burbank
California
Mills Peninsula Health Services
Burlingame
California
Sutter Health - Eden Medical Center
Castro Valley
California
Neurology Center of North Orange County
Fullerton
California
Glendale Adventist Medical Center
Glendale
California
UC Irvine Healthcare Center
Irvine
California
Sharp Grossmont Hospital
La Mesa
California
Long Beach Memorial
Long Beach
California
Kaiser Permanente Los Angeles Medical Center
Los Angeles
California
Mission Hospital Regional Medical Center
Mission Viejo
California
Hoag Memorial Hospital
Newport Beach
California
Stanford Stroke Center
Palo Alto
California
Kaiser Permanente 1
Redwood City
California
University of California Davis Health System
Sacramento
California
Kaiser Permanente
Sacramento
California
California Pacific Medical Center
San Francisco
California
Pacific Neuroscience Institute
Santa Monica
California
Harbor Ucla Medical Center
Torrance
California
Providence Little Company of Mary
Torrance
California
PIH Health Hospital
Whittier
California
University of Colorado
Aurora
Colorado
Nuvance Health Medical Practices Cardiology Danbury
Danbury
Connecticut
MedStar Georgetown University Hospital
Washington D.C.
District of Columbia
MedStar Health Research Institute
Washington D.C.
District of Columbia
Boca Raton Regional Hospital
Boca Raton
Florida
Nova Clinical Research, LLC 1
Bradenton
Florida
Nova Clinical Research, LLC
Bradenton
Florida
Morton Plant Hospital
Clearwater
Florida
Baptist Health 1
Miami
Florida
Advent Health Orlando
Orlando
Florida
Sacred Heart Hospital
Pensacola
Florida
Sarasota Memorial Hospital
Sarasota
Florida
Theia Clincial Research, LLC
Temple Terrace
Florida
Saint Marys Medical Center
West Palm Beach
Florida
Augusta University
Augusta
Georgia
Saint Alphonsus Regional Medical Center- Cancer Care Center
Boise
Idaho
+ 840 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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