A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

NCT05754957
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Phase
Phase 3
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Recruitment status
Completed
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Participants
14,194
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Lead sponsor
Janssen Research & Development, LLC
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Start date
2023-04-07
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Number of sites
1,003
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Summary
The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular \[CV\] death, myocardial infarction \[MI\], and ischemic stroke).
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Acronym
LIBREXIA-ACS
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Short title
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
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Official 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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-02-06
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First posted
2023-03-06
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Registry last updated
2026-07-06
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Primary completion date
2026-02-06
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Start date
2023-04-07
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Actual participants
14,194
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Participants
14,194
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
1,003
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05754957
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ClinicalTrials.gov ID
NCT05754957
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)

    Timeframe: Up to 3 years 6 months

    Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke.

  1. Time to the First Occurrence of Major Adverse Vascular Event (MAVE)

    Timeframe: Up to 3 years 6 months

    Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of CV death, MI, ischemic stroke, major adverse limb event (MALE), and symptomatic venous thromboembolism (VTE).

  2. Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke

    Timeframe: Up to 3 years 6 months

    Time to the first occurrence of composite of ACM, MI and ischemic stroke will be reported.

  3. Time to Cardiovascular (CV) Death

    Timeframe: Up to 3 years 6 months

    Time to CV death will be reported.

  4. Time to All-cause Mortality (ACM)

    Timeframe: Up to 3 years 6 months

    Time to ACM will reported. ACM will be categorized into CV death, non-CV death, and death due to unknown cause.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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)
Sources for eligibility
clinicaltrials.gov

  • Advanced Cardiovascular, LLCAlexander City, United States
  • SORRA ResearchBirmingham, United States
  • Ascension St. Vincent's Health SystemBirmingham, United States
  • IMC-Diagnostic and Medical ClinicMobile, United States
  • Cardiology Associates of Mobile IncMobile, United States
  • Mercy Gilbert Medical CenterGilbert, United States
  • Valleywise Health Medical CenterPhoenix, United States
  • HonorHealth NeurologyScottsdale, United States
  • Arkansas Heart HospitalLittle Rock, United States
  • Bakersfield Memorial HospitalBakersfield, United States
  • Mission Cardiovascular Research InstituteFremont, United States
  • Radin Cardiovascular Medical GroupNewport Beach, United States
  • Valley Clinical Trials, Inc.Northridge, United States
  • Stanford University School of MedicinePalo Alto, United States
  • VA Palo Alto Healthcare SystemPalo Alto, United States
  • Huntington HospitalPasadena, United States
  • The Cardiovascular CenterRedding, United States
  • University Of California San DiegoSan Diego, United States
  • San Diego Cardiac CenterSan Diego, United States
  • VA San Diego Health Care SystemSan Diego, United States
  • UCLASanta Monica, United States
  • NorthBay Clinical Research, LLCSanta Rosa, United States
  • Ramin Manshadi, MDStockton, United States
  • South Denver Cardiology Associates PCLittleton, United States
  • Nuvance Health Medical Practices Cardiology DanburyDanbury, United States

And 978 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2022-501418-69-00
  • 70033093ACS3003
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)