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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Coronary Syndrome

In brief

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).

Key facts

Study ID

NCT05754957

Run by

Janssen Research & Development, LLC

People needed

14194

Starts

2023-04-07

Expected to finish

2026-02-06

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Shanxi Cardiovascular Hospital — Taiyuan, China
• Klinikum Worms gGmbH — Worms, Germany
• Unicare Heart Institute — Surat, India
• Advanced Cardiovascular, LLC — Alexander City, Alabama, United States
• SORRA Research — Birmingham, Alabama, United States
• Ascension St. Vincent's Health System — Birmingham, Alabama, United States
• IMC-Diagnostic and Medical Clinic — Mobile, Alabama, United States
• Cardiology Associates of Mobile Inc — Mobile, Alabama, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• Valleywise Health Medical Center — Phoenix, Arizona, United States
• HonorHealth Neurology — Scottsdale, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Bakersfield Memorial Hospital — Bakersfield, California, United States
• Mission Cardiovascular Research Institute — Fremont, California, United States
• Radin Cardiovascular Medical Group — Newport Beach, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• VA Palo Alto Healthcare System — Palo Alto, California, United States
• Huntington Hospital — Pasadena, California, United States
• The Cardiovascular Center — Redding, California, United States
• University Of California San Diego — San Diego, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• VA San Diego Health Care System — San Diego, California, United States
• UCLA — Santa Monica, California, United States
• Wollongong Hospital — Wollongong, Australia

Full record on ClinicalTrials.gov

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