A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
a study on Ischemic Stroke Stroke Transient Ischemic Attack
Summary
- Eligibility
- for people ages 40 years and up (full criteria)
- Location
- at UC Davis UC Irvine UCLA
- Dates
- study startedcompletion around
Description
Summary
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
Keywords
Ischemic Stroke; Ischemic Attack, Transient, Stroke, Ischemic Stroke, Cerebral Infarction, Transient Ischemic Attack, Ischemia, Milvexian
Eligibility
You can join if…
Open to people ages 40 years and up
- 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 CAN'T join if...
- 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
Locations
- UC Irvine Healthcare Center
accepting new patients
Irvine California 92697 United States - University of California Davis Health System
accepting new patients
Sacramento California 95817 United States - Harbor Ucla Medical Center
completed
Torrance California 90502 United States - California Pacific Medical Center
accepting new patients
San Francisco California 94115 United States - Providence Saint Joseph Medical Center - Cancer Center
accepting new patients
Burbank California 91505 United States - Alta Bates Medical Center Cancer Center
accepting new patients
Berkeley California 94705 United States - Glendale Adventist Medical Center
accepting new patients
Glendale California 91206 United States - Sharp Grossmont Hospital
accepting new patients
La Mesa California 91942 United States - Mills Peninsula Health Services
accepting new patients
Burlingame California 94010 United States - Kaiser Permanente
accepting new patients
Sacramento California 95825-2115 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Janssen Research & Development, LLC
- ID
- NCT05702034
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 15000 study participants
- Last Updated