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OpenTrials
Completed

NCT Number: NCT05754957

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Espanol De Bahia Blanca, Bahía Blanca, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)

Treatment and study plan

Milvexian

Drug

Milvexian will be administered orally.

Other names: JNJ-70033093, BMS-986177

Placebo

Other

Placebo will be administered orally.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 3 years 6 months

    Time to CV death will be reported.

  4. Time to All-cause Mortality (ACM)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Acronym: LIBREXIA-ACS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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