Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

(AEGIS-II Trial)

Recruiting in Palo Alto (17 mi)

+949 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: CSL Behring

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Danielle Duffy, MD

Principal Investigator

CSL Behring - Executive Director, Clinical Development - CV & Metabolism

Eligibility Criteria

Inclusion Criteria

You do not have any signs of sudden kidney damage.

Evidence of myocardial necrosis, consistent with type I (spontaneous) MI

Male or female least 18 years of age

Exclusion Criteria

You are currently experiencing unstable blood pressure or heart rate.

You have a known allergy or sensitivity to soybeans, peanuts, or albumin.

Evidence of severe chronic kidney disease

Treatment Details

Interventions

• CSL112 (Apolipoprotein)

Participant Groups

Group I: CSL112 Experimental Treatment 1 Intervention

Apolipoprotein A-I \[human\]

Group II: Placebo Placebo Group 1 Intervention

25% albumin solution diluted to 4.4%

Who Is Running the Clinical Trial?

CSL Behring

Lead Sponsor

Trials

204

Recruited

1,207,000+

Dr. Paul McKenzie

CSL Behring

Chief Executive Officer since 2023

PhD in Chemical Engineering from Carnegie Mellon University, B.S. in Chemical Engineering from the University of Pennsylvania

Dr. Bill Mezzanotte

CSL Behring

Chief Medical Officer since 2021

MD from Duke University