Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

Purpose

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.

Condition

  • Acute Coronary Syndrome

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CSL112
Apolipoprotein A-I [human]
  • Biological: Apolipoprotein A-I [human] (apoA-I)
    Apolipoprotein A-I [human] (apoA-I) purified from human plasma for intravenous administration
    Other names:
    • CSL112
Placebo Comparator
Placebo
25% albumin solution diluted to 4.4%
  • Other: Placebo
    25% albumin solution diluted to 4.4%

Recruiting Locations

More Details

Status
Recruiting
Sponsor
CSL Behring

Study Contact

Trial Registration Coordinator
610-878-4000
clinicaltrials@cslbehring.com