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

Description

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).

Conditions

Acute Coronary Syndrome

Study Overview

Study Details

Study overview

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).

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

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

Condition
Acute Coronary Syndrome
Intervention / Treatment

-

Contacts and Locations

Alexander City

Advanced Cardiovascular, LLC, Alexander City, Alabama, United States, 35010

Birmingham

SORRA Research, Birmingham, Alabama, United States, 35203

Birmingham

Ascension St. Vincent's Health System, Birmingham, Alabama, United States, 35205

Mobile

IMC-Diagnostic and Medical Clinic, Mobile, Alabama, United States, 36604

Mobile

Cardiology Associates of Mobile Inc, Mobile, Alabama, United States, 36608

Gilbert

Mercy Gilbert Medical Center, Gilbert, Arizona, United States, 85297

Phoenix

Valleywise Health Medical Center, Phoenix, Arizona, United States, 85008

Scottsdale

HonorHealth Neurology, Scottsdale, Arizona, United States, 85258

Little Rock

Arkansas Heart Hospital, Little Rock, Arkansas, United States, 72211

Bakersfield

Bakersfield Memorial Hospital, Bakersfield, California, United States, 93306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2026-12-09