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


Trial ID: NCT05754957


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

Stanford Investigator(s)

Juyong Brian Kim
Juyong Brian Kim

Assistant Professor of Medicine (Cardiovascular Medicine)


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)


drug: Milvexian

other: Placebo


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305