Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Biological: Apolipoprotein A-I [human] (apoA-I)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSL112<br>Apolipoprotein A-I [human] | Biological: Apolipoprotein A-I [human] (apoA-I)<br>* Apolipoprotein A-I [human] (apoA-I) purified from human plasma for intravenous administration<br>* Other names: CSL112;|
| Placebo Comparator: Placebo<br>25% albumin solution diluted to 4.4% | Other: Placebo<br>* 25% albumin solution diluted to 4.4%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of any component of composite MACE (CV death, MI, or stroke ) | MACE [Major adverse cardiovascular event(s)][ (CV (cardiovascular)death, MI (Myocardial Infarction), or stroke) | Through 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key secondary outcome: Total number of hospitalizations for coronary, cerebral, or peripheral ischemia |  | Through 90 days | 
| Key secondary outcome: Time to first occurrence of CV death, MI, or stroke |  | Through 180 days | 
| Key secondary outcome: Time to first occurrence of CV death, MI, or stroke |  | Through 365 days | 
| Time to occurrence of CV death |  | Through 90 days | 
| Time to first occurrence of MI |  | Through 90 days | 
| Time to first occurrence of stroke |  | Through 90 days | 
| Time to occurrence of all-cause death |  | Through 365 days | 
| Number of subjects with adverse events |  | Through 90 days | 
| Percent of subjects with adverse events |  | Through 90 days | 
| Number of subjects with treatment-related adverse events |  | Through 365 days | 
| Percent of subjects with treatment-related adverse events |  | Through 365 days | 
| Number of subjects with serious adverse events |  | Through 365 days | 
| Percent of subjects with serious adverse events |  | Through 365 days | 
| Number of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low) |  | Baseline and 29 days | 
| Percent of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low) |  | Baseline and 29 days |