Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

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).

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

Keywords

Acute Coronary Syndrome, Syndrome, Milvexian

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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)

Locations

  • University Of California San Diego accepting new patients
    San Diego California 92103 United States
  • San Diego Cardiac Center accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05754957
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 16000 study participants
Last Updated