AEGIS-II: 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

Brief Summary:
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.
NCT03473223
Heart & Vascular - Pharma Clinical Trials, Heart & Vascular
John L. Petersen II, MD
Spencer Chee

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 and at least 1 of the following established risk factors:age ≥ 65 years, prior history of MI, diabetes mellitus,or peripheral artery 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
  • Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin
Spencer Chee
206-320-8283
206-215-1500