Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

  • STATUS
    Recruiting
  • End date
    Apr 27, 2023
  • participants needed
    17400
  • sponsor
    CSL Behring
Updated on 27 February 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 on27 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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