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Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

About

Brief Summary

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

Primary Purpose

Prevention

Study Type

Interventional

Phase

Phase III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Male or female least 18 years of age
Evidence of myocardial necrosis, consistent with type I (spontaneous) MI
No suspicion of acute kidney injury
Evidence of multivessel coronary artery disease
Presence of established cardiovascular risk factor(s):
- Diabetes mellitus on pharmacotherapy OR
- 2 or more of the following: age ≥ 65 years, prior history of MI, peripheral arterial disease

Exclusion Criteria:

Ongoing hemodynamic instability
Evidence of hepatobiliary disease
Evidence of severe chronic kidney disease
Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI
Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin

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Study Stats

Protocol No.

18-001287