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(352) 733-0111

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome (AEGIS-II)

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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

Full study title 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
Protocol number OCR19159
ClinicalTrials.gov ID NCT03473223
Phase Phase 3

Eligibility

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):

    1. Diabetes mellitus on pharmacotherapy OR

    2. 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

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.