Clinical Trials in Italy / NCT05702034
Active, not recruiting
Phase 3
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
NCT05702034 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Ischemic Stroke; Ischemic Attack, Transient
Investigational drug(s) / intervention(s)
Milvexian →Placebo
Milvexian: Milvexian will be administered orally.
Placebo: Placebo will be administered orally
Study summary
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
Eligibility
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.
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Official registry record
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.
View NCT05702034 on ClinicalTrials.gov ↗ ← All trials in Italy