RECRUITING

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

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Conditions

Ischemic Stroke; Ischemic Attack, Transient

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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

Quick Facts

Study Start:2023-02-15
Study Completion:2026-12-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05702034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
  3. * 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
  4. * 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
  5. * Willing and able to adhere to the lifestyle restrictions specified in this protocol
  1. * Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (\>) 1 year prior with adequate treatment
  2. * 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
  3. * 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
  4. * 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
  5. * Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
  6. * Known allergies, hypersensitivity, or intolerance to milvexian or its excipients

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

Banner Desert Medical Center
Mesa, Arizona, 85202
United States
University of Arizona
Tucson, Arizona, 85721
United States
Plaza Neuroscience Clinic
Fayetteville, Arkansas, 72703-3902
United States
Alta Bates Medical Center Cancer Center
Berkeley, California, 94705
United States
Providence Saint Joseph Medical Center - Cancer Center
Burbank, California, 91505
United States
Mills Peninsula Health Services
Burlingame, California, 94010
United States
Sutter Health - Eden Medical Center
Castro Valley, California, 94546
United States
Glendale Adventist Medical Center
Glendale, California, 91206
United States
UC Irvine Healthcare Center
Irvine, California, 92697
United States
Sharp Grossmont Hospital
La Mesa, California, 91942
United States
Long Beach Memorial
Long Beach, California, 90806
United States
Stanford Stroke Center
Palo Alto, California, 94304-1419
United States
University of California Davis Health System
Sacramento, California, 95817
United States
Kaiser Permanente
Sacramento, California, 95825-2115
United States
California Pacific Medical Center
San Francisco, California, 94115
United States
Harbor Ucla Medical Center
Torrance, California, 90502
United States
PIH Health Hospital
Whittier, California, 90602
United States
University of Colorado
Aurora, Colorado, 80045
United States
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
MedStar Health Research Institute
Washington, District of Columbia, 20010
United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
United States
Morton Plant Hospital
Clearwater, Florida, 33756-3394
United States
Baptist Health
Miami, Florida, 33173
United States
Advent Health Orlando
Orlando, Florida, 32804-5521
United States
Sacred Heart Hospital
Pensacola, Florida, 32504
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Theia Clincial Research, LLC
Temple Terrace, Florida, 33617
United States
Saint Marys Medical Center
West Palm Beach, Florida, 33407
United States
Augusta University
Augusta, Georgia, 30912
United States
Saint Alphonsus Regional Medical Center- Cancer Care Center
Boise, Idaho, 83706
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60616
United States
Northshore University Healthsystem
Evanston, Illinois, 60201
United States
St. Joseph's Regional Medical Center
Joliet, Illinois, 60435
United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
United States
Blessing Hospital
Quincy, Illinois, 62301
United States
Javon Bea Hospital
Rockford, Illinois, 61114
United States
Prairie Education And Research Cooperative
Springfield, Illinois, 62769
United States
Parkview Research Center
Fort Wayne, Indiana, 46845
United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
United States
Community Hospital Cardiovascular Research
Munster, Indiana, 46321
United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
United States
Ascension via Christi Research
Wichita, Kansas, 67214
United States
University of Kentucky Medical Center
Lexington, Kentucky, 40506
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Pikeville Medical Center
Pikeville, Kentucky, 41537
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Shady Grove Office
Rockville, Maryland, 20850
United States
Comprehensive Neurology Services
Silver Spring, Maryland, 20902
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02216
United States
Detroit Medical Center
Detroit, Michigan, 48201
United States
St John Hospital and Medical Center
Detroit, Michigan, 48236
United States
Michigan State University
East Lansing, Michigan, 48824
United States
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334
United States
Memorial Institute for Neurosciences and Multiple Sclerosis
Owosso, Michigan, 48867
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Providence & Providence Park Hospital
Southfield, Michigan, 48075
United States
M Health Fairview Ridges Hospital
Burnsville, Minnesota, 55337
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
University Of Minnesota Medical Center
Saint Louis Park, Minnesota, 55416
United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801
United States
SSM Health DePaul Hospital
Bridgeton, Missouri, 63044
United States
Cox Health
Springfield, Missouri, 65807
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68106
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915
United States
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
United States
Capital Health Regional Medical Center
Trenton, New Jersey, 08638
United States
Lincoln Hospital
Bronx, New York, 10451
United States
Mercy Hospital
Buffalo, New York, 14220
United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418
United States
United Health Services
Johnson City, New York, 13790
United States
Lenox Hill Hospital
Lake Success, New York, 11041
United States
Weill Cornell Medical College
New York, New York, 10021
United States
Mission Hospital
Asheville, North Carolina, 28801
United States
Novant Health
Charlotte, North Carolina, 28204
United States
Guilford Neurologic Associates
Greensboro, North Carolina, 27405
United States
Summa Health System
Akron, Ohio, 44304
United States
TriHealth Network
Cincinnati, Ohio, 45220
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102
United States
Ascension Medical Group - St. John Clinic Infectious Disease
Tulsa, Oklahoma, 74104
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence St Vincent Medical Center
Portland, Oregon, 97225
United States
Oregon Health And Science University
Portland, Oregon, 97239
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
UPMC Hamot
Erie, Pennsylvania, 16550
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
United States
Centennial Medical Center
Nashville, Tennessee, 37203
United States
TriStar Skyline Medical Center
Nashville, Tennessee, 37207
United States
Saint Thomas Health
Nashville, Tennessee, 37215
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Seton Medical Center
Austin, Texas, 78701
United States
Baylor Research Institute
Dallas, Texas, 75204
United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75231
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Houston Methodist Neurological Institute
Houston, Texas, 77030
United States
Houston Methodist Willowbrook Hospital
Houston, Texas, 77070
United States
Sentara Medical Group
Norfolk, Virginia, 23502
United States
Winchester Medical Center
Winchester, Virginia, 22601
United States
Providence Regional Medical Center Everett
Everett, Washington, 98201
United States
Multiple Sclerosis Center at Evergreen
Kirkland, Washington, 98034
United States
Sacred Heart Medical Center
Spokane, Washington, 99204
United States
Mayo Clinic Health System
Eau Claire, Wisconsin, 54703
United States
Mayo Clinic Health System
La Crosse, Wisconsin, 54601
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-15
Study Completion Date2026-12-09

Study Record Updates

Study Start Date2023-02-15
Study Completion Date2026-12-09

Terms related to this study

Additional Relevant MeSH Terms

  • Ischemic Stroke; Ischemic Attack, Transient