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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05754957




Registration number
NCT05754957
Ethics application status
Date submitted
23/02/2023
Date registered
6/03/2023

Titles & IDs
Public title
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome
Secondary ID [1] 0 0
70033093ACS3003
Secondary ID [2] 0 0
CR109271
Universal Trial Number (UTN)
Trial acronym
LIBREXIA-ACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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

Experimental: Milvexian - Participants enrolled within 7 days of an acute coronary syndrome (ACS), who have undergone cardiac catheterization with percutaneous intervention (PCI) or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (single antiplatelet therapy \[SAPT\] or dual antiplatelet therapy \[DAPT\]) as determined by the investigator will receive milvexian 25 milligrams (mg), orally, twice daily.

Placebo comparator: Placebo - Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally, twice daily.


Treatment: Drugs: Milvexian
Milvexian will be administered orally.

Other interventions: Placebo
Placebo will be administered orally.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)
Timepoint [1] 0 0
Up to 3 years 6 months
Secondary outcome [1] 0 0
Time to the First Occurrence of Major Adverse Vascular Event (MAVE)
Timepoint [1] 0 0
Up to 3 years 6 months
Secondary outcome [2] 0 0
Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke
Timepoint [2] 0 0
Up to 3 years 6 months
Secondary outcome [3] 0 0
Time to Cardiovascular (CV) Death
Timepoint [3] 0 0
Up to 3 years 6 months
Secondary outcome [4] 0 0
Time to All-cause Mortality (ACM)
Timepoint [4] 0 0
Up to 3 years 6 months

Eligibility
Key inclusion criteria
* Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction [STEMI], non-STEMI, or unstable angina [UA]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB [CK-MB]) above the upper limit of normal as determined by the local laboratory
* Participants must have at least 2 of the following risk factors:a) age 65 or older, b) diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis, intracranial artery stenosis, g) conservative management (that is, no percutaneous intervention [PCI] or CABG after index ACS event), h) Any one or more of the following high-risk angiographic features i) total stent length of greater than (>) 30 millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with more than one stent, iv) calcified target lesion treated with atherectomy, v) treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI)
* All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening
* A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event
* Planned CABG or staged PCI after randomization
* Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines
* Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
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Cairns Base Hospital - Cairns
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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Royal Brisbane and Women's Hospital - Herston
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Royal Hobart Hospital - Hobart
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Nepean Hospital - Kingswood
Recruitment hospital [10] 0 0
Core Research Group - Milton
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
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Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
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3350 - Ballarat
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4575 - Birtinya
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4870 - Cairns
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2050 - Camperdown
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2139 - Concord
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4029 - Herston
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7000 - Hobart
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2747 - Kingswood
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4064 - Milton
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6150 - Murdoch
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2145 - Sydney
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Germany
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Germany
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India
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India
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India
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India
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India
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India
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India
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India
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India
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Israel
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Israel
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Israel
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Italy
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Italy
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Italy
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Italy
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Italy
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Italy
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Sesto San Giovanni
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Italy
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Torrette Di Ancona
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Italy
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Japan
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Aichi
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Japan
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Japan
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Chiba
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Gunma
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Itabashi Ku
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Japan
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Izunokuni-shi
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Japan
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Kamogawa
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Japan
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Japan
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Japan
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Japan
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Japan
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Kitakyushu-shi
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Japan
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Kochi
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Japan
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Koga
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Japan
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Japan
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Japan
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Japan
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Japan
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Kyoto
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Philippines
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Philippines
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Philippines
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Poland
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Poland
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Portugal
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Romania
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Romania
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Romania
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Romania
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Serbia
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Serbia
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Slovakia
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.