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Completed

NCT Number: NCT03473223

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

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.

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Key information

Conditions

Acute Coronary Syndrome Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Artery Disease Coronary Disease Heart Diseases Heart Failure Heart Valve Diseases Hemorrhagic Stroke Hypertension Ischemic Stroke Myocardial Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

0320069 - Hospital Italiano Regional del Sur, Bahía Blanca, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apolipoprotein A-I [human] (apoA-I)

Biological

Apolipoprotein A-I [human] (apoA-I) purified from human plasma for intravenous administration

Other names: CSL112

Placebo

Other

25% albumin solution diluted to 4.4%

Primary outcomes

  1. Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)

    Time frame: From the time of randomization through 90 days

    MACE (Major adverse cardiovascular event[s])(CV [cardiovascular] death, MI [Myocardial Infarction], or stroke).

Secondary outcomes

  1. Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia

    Time frame: From the time of randomization through 90 days

    The total number of hospitalizations and individual hospitalizations due to coronary, cerebral, and peripheral ischemia were reported.

  2. Number of Participants With First Occurrence of CV Death, MI, or Stroke

    Time frame: From the time of randomization through 180 days

  3. Number of Participants With First Occurrence of CV Death, MI, or Stroke

    Time frame: From the time of randomization through 365 days

  4. Number of Participants With Occurrence of CV Death

    Time frame: From the time of randomization through 90 days

  5. Number of Participants With First Occurrence of MI

    Time frame: From the time of randomization through 90 days

  6. Number of Participants With First Occurrence of Stroke

    Time frame: From the time of randomization through 90 days

  7. Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke

    Time frame: From the time of randomization through 90, 180 and 365 days

  8. Number of Participants With Occurrence of All-cause Death

    Time frame: From the time of randomization through 365 days

  9. Number of Participants With Adverse Events

    Time frame: From the start of treatment through 90 days

    An AE was defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.

  10. Percentage of Participants With Adverse Events

    Time frame: From the start of treatment through 90 days

    An AE was defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.

  11. Number of Participants With Treatment-related Adverse Events

    Time frame: From the start of treatment through 379 days (Day 365 + 14 days of follow up)

    Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product.

  12. Percentage of Participants With Treatment-related Adverse Events

    Time frame: From the start of treatment through 379 days (Day 365 + 14 days of follow up)

    Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product. As per the study statistical analysis plan (SAP), descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented.

  13. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: From the start of treatment through 379 days (Day 365 + 14 days of follow up)

    SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is a medically significant event.

  14. Percentage of Participants With SAEs

    Time frame: From the start of treatment through 379 days (Day 365 + 14 days of follow up)

    SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is a medically significant event. As per the study SAP, descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented.

  15. Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments

    Time frame: Baseline and 29 days

    Clinical laboratory assessments included assessment of Hematology (hemoglobin, hematocrit, leukocytes and platelets) and Biochemistry (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin, direct bilirubin, indirect bilirubin and estimated glomerular filtration rate [eGFR]). The number of participants with a shift from the Baseline value to the worst post-treatment value (low, normal, or high) was reported. The worst criterion for the parameters is as follows: hematocrit - low, hemoglobin - low, leukocytes - high, platelets - low, ALT - high, ALP - high, AST - high, bilirubin - high, direct bilirubin - high, indirect bilirubin - high, eGFR - severe impairment.

  16. Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments

    Time frame: Baseline and 29 days

    Clinical laboratory assessments included assessment of Hematology (hemoglobin, hematocrit, leukocytes and platelets) and Biochemistry (ALP, ALT, AST, bilirubin, direct bilirubin, indirect bilirubin and eGFR). Percentage of participants with a shift from the Baseline value to the worst post-treatment value (low, normal, or high) was reported. The worst criterion for the parameters is as follows: hematocrit - low, hemoglobin - low, leukocytes - high, platelets - low, ALT - high, ALP - high, AST - high, bilirubin - high, direct bilirubin - high, indirect bilirubin - high, eGFR - severe impairment. As per the study SAP, descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented.

  17. Change From Baseline in Hematology Parameters

    Time frame: From Baseline to Day 29

    Hematology parameters included Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets.

  18. Change From Baseline in Hematology Parameter: Hematocrit

    Time frame: From Baseline to Day 29

  19. Change From Baseline in Hematology Parameter: Hemoglobin

    Time frame: From Baseline to Day 29

  20. Change From Baseline in Hepatic Parameters

    Time frame: From Baseline to Day 29

    Hepatic parameters included ALT, ALP and AST.

  21. Change From Baseline in Hepatic Parameter: Bilirubin

    Time frame: From Baseline to Day 29

  22. Change From Baseline in Renal Parameter: Serum Creatinine

    Time frame: From Baseline to Day 29

  23. Change From Baseline in Renal Parameter: eGFR

    Time frame: From Baseline to Day 29

  24. Change From Baseline in Renal Parameter: Blood Urea Nitrogen

    Time frame: From Baseline to Day 29

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official 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

Acronym: AEGIS-II

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2018
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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