Acute coronary syndrome is a life-threatening condition, which most commonly occurs when an
atherosclerotic plaque ruptures or erodes, leading to thrombus formation within a coronary
artery. A thrombus within a coronary artery can result in unstable angina, MI, or sudden
death. Even after recovery from an acute episode of ACS, patients continue to be at
heightened risk.
CSL112 is a novel formulation of apoA-I, the major functional component of high-density
lipoprotein. 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) in subjects with ACS (diagnosed with STEMI or NSTEMI), who are
receiving evidence-based medical therapy. Subjects will be randomized 1:1 to 1 of 2 treatment
groups (CSL112 6 g or placebo). Randomization at baseline will be stratified by subjects'
index MI type (STEMI vs NSTEMI), management of the index MI (PCI vs medically managed), and
region (North America, Latin America, Western Europe, Central and Eastern Europe, or Asia
Pacific).