A study on Milvexian in study participants after an acute ischemic stroke or a high-risk transient ischemic attack

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam (ICTRP)

ICTRP Trial ID
NCT05702034 (ICTRP)

Official title (approved by ethics committee)
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 (BASEC)

Academic 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 (ICTRP)

Public title
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE (ICTRP)

Disease under investigation
Ischemic Stroke Ischemic Attack, Transient (ICTRP)

Intervention under investigation
Drug: MilvexianDrug: Placebo (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Inclusion/Exclusion criteria
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 (ICTRP)

not available

Primary and secondary end points
Time to First Occurrence of Ischemic Stroke (ICTRP)

Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke;Time to First Occurrence of Ischemic Stroke;Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE) (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
Bristol Myers Squibb Company (BMS) (ICTRP)

Additional contacts
Janssen Research & Development, LLC Clinical Trial;Study Contact, Participate-In-This-Study@its.jnj.com, 844-434-4210, Janssen Research & Development, LLC, (ICTRP)

Secondary trial IDs
70033093STR3001, 2022-501176-26-00, CR109231 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05702034 (ICTRP)