Home › Trials › NCT05754957

Evaluating milvexian for patients after acute coronary syndrome

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

Phase 3 Interventional Janssen Research & Development, LLC · NCT05754957

This study tests if a new medication called milvexian can help people who recently had a heart problem lower their risk of serious heart events compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment16000 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations998 sites (Alexander City, Alabama and 997 other locations)
Trial IDNCT05754957 on ClinicalTrials.gov

What this trial studies

This study aims to determine if milvexian is more effective than a placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients who have recently experienced an acute coronary syndrome (ACS). Participants will receive either milvexian or a placebo in addition to standard care. The study focuses on individuals who have had a recent ACS event and meet specific risk criteria. The primary outcome will be the incidence of cardiovascular death, myocardial infarction, and ischemic stroke.

Who should consider this trial

Good fit: Ideal candidates are individuals who have experienced an acute coronary syndrome event within the past week and have additional cardiovascular risk factors.

Not a fit: Patients who do not have a recent acute coronary syndrome event or lack the specified risk factors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the risk of serious cardiovascular events in patients recovering from acute coronary syndrome.

How similar studies have performed: Previous studies have shown promise in using novel anticoagulants for similar patient populations, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Alexander City, Alabama and 997 other locations

+948 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Coronary Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.