A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome (LIBREXIA-ACS)
Study on Investigational Medication for Reducing Cardiovascular Events After Sudden Heart-Related Conditions
Manuel Rivera Maza
Primary Investigator
Brief description of study
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute Coronary Syndrome
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Age: 18 years or above
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Gender: All
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)
This study investigates the effects of an investigational medication in people who have experienced a recent acute coronary syndrome (ACS). ACS is a condition characterized by sudden, reduced blood flow to the heart, which can result in heart attacks or unstable chest pain. The purpose of this study is to determine if the investigational medication, when added to standard care, can lower the risk of major cardiovascular events such as heart attacks, strokes, or cardiovascular death.
Participants in the study will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will monitor the occurrence of cardiovascular events and assess the safety and effectiveness of the investigational medication.
- Who can participate: Participants must have experienced an acute coronary syndrome event within 7 days before joining the study. They should be 65 years or older, have diabetes, or have a history of myocardial infarction or multivessel coronary artery disease. Women who can become pregnant must test negative for pregnancy before participating.
- Study details: Participants will receive either the investigational medication or a placebo. The study will compare the effects to determine if the investigational medication reduces major cardiovascular events.
