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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
18,226
Apolipoprotein A-I \[human\] (apoA-I) purified from human plasma for intravenous administration
25% albumin solution diluted to 4.4%
Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)
MACE (Major adverse cardiovascular event\[s\])(CV \[cardiovascular\] death, MI \[Myocardial Infarction\], or stroke).
Time frame: From the time of randomization through 90 days
Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia
The total number of hospitalizations and individual hospitalizations due to coronary, cerebral, and peripheral ischemia were reported.
Time frame: From the time of randomization through 90 days
Number of Participants With First Occurrence of CV Death, MI, or Stroke
Time frame: From the time of randomization through 180 days
Number of Participants With First Occurrence of CV Death, MI, or Stroke
Time frame: From the time of randomization through 365 days
Number of Participants With Occurrence of CV Death
Time frame: From the time of randomization through 90 days
Number of Participants With First Occurrence of MI
Time frame: From the time of randomization through 90 days
Number of Participants With First Occurrence of Stroke
Time frame: From the time of randomization through 90 days
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
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8400896 - Advanced Cardiovascular LLC
Alexander City, Alabama, United States
8400350 - Cardiology, PC
Birmingham, Alabama, United States
8400337 - Heart Center Research, LLC
Huntsville, Alabama, United States
8400713 - University of South Alabama College of Medicine
Mobile, Alabama, United States
8400556 - Mercy Gilbert Medical Center
Gilbert, Arizona, United States
8400747 - Phoenix V.A. Health Care System
Phoenix, Arizona, United States
8400772 - Mayo Clinic Arizona
Phoenix, Arizona, United States
8400996 - Southern Arizona V.A. Healthcare System
Tucson, Arizona, United States
8400645 - NEA Baptist Clinic
Jonesboro, Arkansas, United States
8400975 - Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
...and 893 more locations
Number of Participants With Occurrence of All-cause Death
Time frame: From the time of randomization through 365 days
Number of Participants With Adverse Events
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.
Time frame: From the start of treatment through 90 days
Percentage of Participants With Adverse Events
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.
Time frame: From the start of treatment through 90 days
Number of Participants With Treatment-related Adverse Events
Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product.
Time frame: From the start of treatment through 379 days (Day 365 + 14 days of follow up)
Percentage of Participants With Treatment-related Adverse Events
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.
Time frame: From the start of treatment through 379 days (Day 365 + 14 days of follow up)
Number of Participants With Serious Adverse Events (SAEs)
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.
Time frame: From the start of treatment through 379 days (Day 365 + 14 days of follow up)
Percentage of Participants With SAEs
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.
Time frame: From the start of treatment through 379 days (Day 365 + 14 days of follow up)
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments
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.
Time frame: Baseline and 29 days
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments
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.
Time frame: Baseline and 29 days
Change From Baseline in Hematology Parameters
Hematology parameters included Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets.
Time frame: From Baseline to Day 29
Change From Baseline in Hematology Parameter: Hematocrit
Time frame: From Baseline to Day 29
Change From Baseline in Hematology Parameter: Hemoglobin
Time frame: From Baseline to Day 29
Change From Baseline in Hepatic Parameters
Hepatic parameters included ALT, ALP and AST.
Time frame: From Baseline to Day 29
Change From Baseline in Hepatic Parameter: Bilirubin
Time frame: From Baseline to Day 29
Change From Baseline in Renal Parameter: Serum Creatinine
Time frame: From Baseline to Day 29
Change From Baseline in Renal Parameter: eGFR
Time frame: From Baseline to Day 29
Change From Baseline in Renal Parameter: Blood Urea Nitrogen
Time frame: From Baseline to Day 29