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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05702034




Registration number
NCT05702034
Ethics application status
Date submitted
19/01/2023
Date registered
27/01/2023
Date last updated
22/05/2024

Titles & IDs
Public title
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
Scientific 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
Secondary ID [1] 0 0
70033093STR3001
Secondary ID [2] 0 0
CR109231
Universal Trial Number (UTN)
Trial acronym
LIBREXIA-STROK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke; Ischemic Attack, Transient 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Milvexian
Treatment: Drugs - Placebo

Experimental: 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.

Placebo Comparator: 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.


Treatment: Drugs: Milvexian
Milvexian will be administered orally.

Treatment: Drugs: Placebo
Placebo will be administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Ischemic Stroke
Timepoint [1] 0 0
Up to global targeted endpoint date (approximately 41 months)
Secondary outcome [1] 0 0
Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke
Timepoint [1] 0 0
Up to global targeted endpoint date (approximately 41 months)
Secondary outcome [2] 0 0
Time to First Occurrence of Ischemic Stroke
Timepoint [2] 0 0
Up to Day 90
Secondary outcome [3] 0 0
Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE)
Timepoint [3] 0 0
Up to global targeted endpoint date (approximately 41 months)

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/12/2026
Actual
Sample size
Target
15000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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Flinders Medical Centre - Adelaide
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Monash Medical Centre - Clayton
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St Vincent's Hospital - Melbourne - Fitzroy
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Austin Health - Heidelberg
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Royal Brisbane and Women's Hospital - Herston
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Launceston General Hospital - Launceston
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Fiona Stanley Hospital - Murdoch
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Royal Melbourne Hospital - Parkville
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Latrobe Regional Hospital - Traralgon
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Princess Alexandra Hospital - Woolloongabba
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5042 - Adelaide
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3168 - Clayton
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3065 - Fitzroy
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3084 - Heidelberg
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4029 - Herston
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7250 - Launceston
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2170 - Liverpool
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6150 - Murdoch
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3050 - Parkville
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4215 - Southport
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3844 - Traralgon
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4102 - Woolloongabba
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Bristol Myers Squibb Company (BMS)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05702034
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05702034