Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

  • STATUS
    Recruiting
  • End date
    Apr 13, 2023
  • participants needed
    17400
  • sponsor
    CSL Behring
Updated on 13 June 2021
diabetes
stroke
myocardial infarction
stemi
infarct
percutaneous coronary intervention
acute coronary syndrome
arterial disease

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.

Details
Condition Acute Coronary Syndrome, Ischemic Heart Disease, Cardiac Ischemia, Myocardial Ischemia, acute coronary syndromes
Treatment Placebo, Apolipoprotein A-I [human] (apoA-I)
Clinical Study IdentifierNCT03473223
SponsorCSL Behring
Last Modified on13 June 2021

Eligibility

Yes No Not Sure

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
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