Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

  • STATUS
    Recruiting
  • End date
    Apr 17, 2023
  • participants needed
    17400
  • sponsor
    CSL Behring
Updated on 17 January 2021
Investigator
Trial Registration Coordinator
Primary Contact
8400904 - Northeast Iowa Medical Education Foundation (1.5 mi away) Contact
+3410 other location
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
Treatment Placebo, Apolipoprotein A-I [human] (apoA-I)
Clinical Study IdentifierNCT03473223
SponsorCSL Behring
Last Modified on17 January 2021

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Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: acute coronary syndromes or Acute Coronary Syndrome or Ischemic Heart Disease or Cardiac Ischemia or Myocardial Ischemia?
Do you have any of these conditions: acute coronary syndromes or Myocardial Ischemia or Cardiac Ischemia or Ischemic Heart Disease or Acute Coronary Syndrome?
Do you have any of these conditions: Myocardial Ischemia or Cardiac Ischemia or Acute Coronary Syndrome or Ischemic Heart Disease or acute coronary syndromes?
Do you have any of these conditions: Myocardial Ischemia or Ischemic Heart Disease or Cardiac Ischemia or Acute Coronary Syndrome or acute coronary syndromes?
Do you have any of these conditions: Cardiac Ischemia or Ischemic Heart Disease or acute coronary syndromes or Myocardial Ischemia or Acute Coronary Syndrome?
Do you have any of these conditions: Myocardial Ischemia or Acute Coronary Syndrome or Cardiac Ischemia or acute coronary syndromes or Ischemic Heart Disease?
Do you have any of these conditions: Myocardial Ischemia or acute coronary syndromes or Cardiac Ischemia or Ischemic Heart Disease or Acute Coronary Syndrome?
Do you have any of these conditions: Ischemic Heart Disease or Myocardial Ischemia or acute coronary syndromes or Cardiac Ischemia or Acute Coronary Syndrome?
Do you have any of these conditions: Acute Coronary Syndrome or Cardiac Ischemia or Ischemic Heart Disease or acute coronary syndromes or Myocardial Ischemia?
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: Myocardial Ischemia or Ischemic Heart Disease or acute coronary syndromes or Acute Coronary Syndrome or Cardiac Ischemia?
Do you have any of these conditions: Acute Coronary Syndrome or acute coronary syndromes or Ischemic Heart Disease or Cardiac Ischemia or Myocardial Ischemia?
Do you have any of these conditions: Ischemic Heart Disease or acute coronary syndromes or Myocardial Ischemia or Acute Coronary Syndrome or Cardiac Ischemia?
Do you have any of these conditions: Acute Coronary Syndrome or acute coronary syndromes or Myocardial Ischemia or Cardiac Ischemia or Ischemic Heart Disease?
Do you have any of these conditions: Ischemic Heart Disease or Cardiac Ischemia or Acute Coronary Syndrome or acute coronary syndromes or Myocardial Ischemia?
Do you have any of these conditions: Ischemic Heart Disease or Acute Coronary Syndrome or Myocardial Ischemia or Cardiac Ischemia?
Gender: Male or Female
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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