Librexia-ACS
Trial Overview
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
Study Purpose
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).
Eligibility
Patients must be enrolled within 7 days of their event.
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
Patients with significant bleeding risk will not be eligible. Inquire for full inclusion and exclusion criteria.
Intervention
Milvexian versus placebo
For more information, visit the U.S. National Library of Medicine clinical trial database.