A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
- Conditions
- Ischemic Stroke; Ischemic Attack, Transient
- Interventions
- Drug: Placebo
- Registration Number
- NCT05702034
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants after an acute ischemic stroke or high-risk TIA who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) will receive placebo orally twice daily. Milvexian Milvexian Participants after an acute ischemic stroke or high-risk transient ischemic attack (TIA) who are receiving antiplatelet therapy standard-of-care (SAPT \[single antiplatelet therapy\] or DAPT \[dual antiplatelet therapy\]) will receive milvexian 25 milligrams (mg), orally, twice daily.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Time to First Occurrence of Ischemic Stroke Up to Day 90 Time to first occurrence of ischemic stroke in the first 90 days will be reported.
Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke Up to global targeted endpoint date (approximately 41 months) Time to first occurrence of any component of the composite of CVD, MI, or ischemic stroke will be reported.
Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE) Up to global targeted endpoint date (approximately 41 months) Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of (CVD), myocardial infarction (MI), ischemic stroke, major adverse limb events (MALE), symptomatic pulmonary embolism (PE) or deep vein thrombosis (DVT).
Trial Locations
- Locations (848)
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Plaza Neuroscience Clinic
🇺🇸Fayetteville, Arkansas, United States
Alta Bates Medical Center Cancer Center
🇺🇸Berkeley, California, United States
Providence Saint Joseph Medical Center - Cancer Center
🇺🇸Burbank, California, United States
Mills Peninsula Health Services
🇺🇸Burlingame, California, United States
Sutter Health - Eden Medical Center
🇺🇸Castro Valley, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
UC Irvine Healthcare Center
🇺🇸Irvine, California, United States
Scroll for more (838 remaining)Banner Desert Medical Center🇺🇸Mesa, Arizona, United States