Rationale and design of ApoA-I Event Reducing in Ischemic Syndromes II (AEGIS-II): A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of CSL112 in subjects after acute myocardial infarction

Acute myocardial infarction (MI) patients remain at high risk for recurrent events. Cholesterol efflux, mediated by apolipoprotein A-I, removes excess cholesterol from atherosclerotic plaque and transports it to the liver excretion. Impaired efflux is associated with higher cardiovascular (CV) event rates among both stable coronary artery disease recent MI. CSL112, a novel intravenous formulation of A-I (human) derived human plasma, increases capacity. AEGIS-II phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial investigating efficacy safety CSL112 compared placebo high-risk acute MI participants. Eligibility criteria include age ≥ 18 years type 1 (spontaneous) MI, evidence multivessel disease, presence diabetes requiring pharmacotherapy, or ≥2 following: 65 years, prior peripheral disease. A target sample 17,400 participants will be randomized 1:1 receive 4 weekly infusions 6 g placebo, initiated on day discharge within 5 days first medical contact. The primary outcome time occurrence composite CV death, stroke through 90 days. Key secondary outcomes total number hospitalizations coronary, cerebral, ischemia 180 365 formally test whether enhancing can reduce rate major adverse