Open Actively Recruiting

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

About

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.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
18-001287
Category
Cardiology
Principal Investigator
Contact
Ladda Douangvila-Chhan
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03473223
For detailed technical eligibility, visit ClinicalTrials.gov.