A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischem… (NCT05702034) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
United States12,532 participantsStarted 2023-02-15
Plain-language summary
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prot…
What they're measuring
1
Time to First Occurrence of Ischemic Stroke
Timeframe: Up to global targeted endpoint date (approximately 41 months)