A Phase 3 interventional study of Apolipoprotein A-I [human] (apoA-I) and Placebo in Acute Coronary Syndrome, sponsored by CSL Behring. Completed at 903 sites in 49 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by CSL Behring · Phase 3, Interventional, and Prevention
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.
Presence of established cardiovascular risk factor(s):
Exclusion Criteria:
Apolipoprotein A-I \[human\]
Biological: Apolipoprotein A-I [human] (apoA-I)
25% albumin solution diluted to 4.4%
Other: Placebo
Apolipoprotein A-I \[human\] (apoA-I) purified from human plasma for intravenous administration
Also known as: CSL112
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
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
The study was conducted at 897 centers across 5 regions (North America, Latin America, Western Europe, Central and Eastern Europe, and Asia Pacific).
| Milestone | CSL112 | Placebo |
|---|---|---|
| Started | 9114 | 9112 |
| Intent-to-treat (itt) analysis set | 9112 | 9107 |
| Safety analysis set (sas) | 9010 | 9027 |
| Completed | 9002 | 9020 |
| Not completed | 112 | 92 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 47 | 42 |
| Withdrew: Indirect contact | 32 | 29 |
| Withdrew: Other (not specified) | 32 | 20 |
MACE (Major adverse cardiovascular event\[s\])(CV \[cardiovascular\] death, MI \[Myocardial Infarction\], or stroke).
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke) | 439 | 472 |
The total number of hospitalizations and individual hospitalizations due to coronary, cerebral, and peripheral ischemia were reported.
| hospitalizations | CSL112 | Placebo |
|---|---|---|
| Total hospitalizations | 433 | 442 |
| Coronary ischemia | 367 | 376 |
| Cerebral ischemia | 39 | 36 |
| Peripheral ischemia | 27 | 30 |
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With First Occurrence of CV Death, MI, or Stroke | 622 | 683 |
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With First Occurrence of CV Death, MI, or Stroke | 885 | 944 |
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With Occurrence of CV Death | 107 | 128 |
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With First Occurrence of MI | 312 | 342 |
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Stroke | 57 | 49 |
| Participants | CSL112 | Placebo |
|---|---|---|
| Through Day 90 | 272 | 308 |
| Through Day 180 | 400 | 444 |
| Through Day 365 | 594 | 639 |
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With Occurrence of All-cause Death | 341 | 345 |
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.
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With Adverse Events | 3938 | 3927 |
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.
| percentage of participants | CSL112 | Placebo |
|---|---|---|
| Percentage of Participants With Adverse Events | 43.7 | 43.5 |
Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product.
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | 350 | 304 |
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.
| percentage of participants | CSL112 | Placebo |
|---|---|---|
| Percentage of Participants With Treatment-related Adverse Events | 3.9 | 3.4 |
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.
| Participants | CSL112 | Placebo |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 1514 | 1557 |
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.
| percentage of participants | CSL112 | Placebo |
|---|---|---|
| Percentage of Participants With SAEs | 16.8 | 17.2 |
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.
| Participants | CSL112 | Placebo |
|---|---|---|
| Hematocrit - High to Low | 0 | 1 |
| Hematocrit - Normal to Low | 365 | 393 |
| Hemoglobin - High to Low | 0 | 1 |
| Hemoglobin - Normal to Low | 457 | 447 |
| Leukocytes - Normal to High | 267 | 271 |
| Leukocytes - Low to High | 2 | 1 |
| Platelets - High to Low | 0 | 0 |
| Platelets - Normal to Low | 92 | 114 |
| ALT - Normal to High | 658 | 612 |
| ALT - Low to High | 0 | 0 |
| ALP - Normal to High | 307 | 350 |
| ALP - Low to High | 1 | 0 |
| AST - Normal to High | 239 | 253 |
| AST - Low to High | 2 | 0 |
| Bilirubin - Normal to High | 73 | 112 |
| Bilirubin - Low to High | 0 | 1 |
| Direct Bilirubin - Normal to High | 18 | 21 |
| Direct Bilirubin - Low to High | 0 | 0 |
| Indirect Bilirubin - Normal to High | 31 | 42 |
| Indirect Bilirubin - Low to High | 0 | 0 |
| eGFR - Normal to Severe Impairment | 1 | 2 |
| eGFR - Mild Impairment to Severe Impairment | 15 | 9 |
| eGFR - Moderate Impairment to Severe Impairment | 91 | 99 |
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.
| percentage of participants | CSL112 | Placebo |
|---|---|---|
| Hematocrit - High to Low | 0.0 | 0.0 |
| Hematocrit - Normal to Low | 5.3 | 5.8 |
| Hemoglobin - High to Low | 0.0 | 0.0 |
| Hemoglobin - Normal to Low | 6.3 | 6.2 |
| Leukocytes - Normal to High | 3.7 | 3.8 |
| Leukocytes - Low to High | 0.0 | 0.0 |
| Platelets - High to Low | 0.0 | 0.0 |
| Platelets - Normal to Low | 1.3 | 1.6 |
| ALT - Normal to High | 8.3 | 7.7 |
| ALT - Low to High | 0.0 | 0.0 |
| ALP - Normal to High | 3.7 | 4.2 |
| ALP - Low to High | 0.0 | 0.0 |
| AST - Normal to High | 3.0 | 3.2 |
| AST - Low to High | 0.0 | 0.0 |
| Bilirubin - Normal to High | 0.9 | 1.4 |
| Bilirubin - Low to High | 0.0 | 0.0 |
| Direct Bilirubin - Normal to High | 0.2 | 0.3 |
| Direct Bilirubin - Low to High | 0.0 | 0.0 |
| Indirect Bilirubin - Normal to High | 0.4 | 0.6 |
| Indirect Bilirubin - Low to High | 0.0 | 0.0 |
| eGFR - Normal to Severe Impairment | 0.0 | 0.0 |
| eGFR - Mild Impairment to Severe Impairment | 0.2 | 0.1 |
| eGFR - Moderate Impairment to Severe Impairment | 1.1 | 1.2 |
Hematology parameters included Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets.
| 10^9 cells per liter | CSL112 | Placebo |
|---|---|---|
| Basophils | 0.004 ± 0.0455 | 0.005 ± 0.0462 |
| Eosinophils | 0.045 ± 0.1766 | 0.047 ± 0.1727 |
| Leukocytes | -1.024 ± 2.2905 | -0.969 ± 2.2683 |
| Lymphocytes | 0.084 ± 0.5534 | 0.080 ± 0.5409 |
| Monocytes | -0.089 ± 0.1886 | -0.087 ± 0.1961 |
| Neutrophils | -1.068 ± 2.0892 | -1.011 ± 2.0343 |
| Platelets | 0.4 ± 56.09 | -1.4 ± 55.31 |
| liter per liter (L/L) | CSL112 | Placebo |
|---|---|---|
| Change From Baseline in Hematology Parameter: Hematocrit | -0.003 ± 0.0382 | -0.004 ± 0.0381 |
| grams per liter (g/L) | CSL112 | Placebo |
|---|---|---|
| Change From Baseline in Hematology Parameter: Hemoglobin | -1.1 ± 11.96 | -1.3 ± 12.08 |
Hepatic parameters included ALT, ALP and AST.
| units per liter | CSL112 | Placebo |
|---|---|---|
| ALT | -5.5 ± 25.52 | -6.5 ± 28.91 |
| ALP | 3.2 ± 26.13 | 4.5 ± 24.55 |
| AST | -21.2 ± 41.90 | -20.7 ± 61.63 |
| micromol per liter (umol/L) | CSL112 | Placebo |
|---|---|---|
| Bilirubin | -2.6 ± 4.71 | -1.9 ± 5.05 |
| Direct Bilirubin | -0.4 ± 1.32 | -0.3 ± 1.75 |
| Indirect Bilirubin | -2.0 ± 3.85 | -1.4 ± 3.90 |
| umol/L | CSL112 | Placebo |
|---|---|---|
| Change From Baseline in Renal Parameter: Serum Creatinine | 2.4 ± 24.39 | 2.1 ± 21.23 |
| milliliter per minute per 1.73 meter^2 | CSL112 | Placebo |
|---|---|---|
| Change From Baseline in Renal Parameter: eGFR | -1.3 ± 11.87 | -1.2 ± 12.15 |
| millimoles per liter | CSL112 | Placebo |
|---|---|---|
| Change From Baseline in Renal Parameter: Blood Urea Nitrogen | 0.0 ± 2.76 | 0.0 ± 2.67 |
Collected over All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CSL112 | 348/9,112 (3.8%) | 1,514/9,010 (16.8%) | 0/9,010 (0%) |
| Placebo | 355/9,107 (3.9%) | 1,557/9,027 (17.2%) | 0/9,027 (0%) |
| Event | CSL112 | Placebo |
|---|---|---|
| Angina pectorisCardiac disorders | 106/9010 | 84/9027 |
| PneumoniaInfections and infestations | 97/9010 | 89/9027 |
| Non-cardiac chest painGeneral disorders | 92/9010 | 78/9027 |
| Angina unstableCardiac disorders | 69/9010 | 59/9027 |
| Acute kidney injuryRenal and urinary disorders | 68/9010 | 66/9027 |
| Cardiac failureCardiac disorders | 54/9010 | 64/9027 |
| CholecystitisHepatobiliary disorders | 57/9010 | 12/9027 |
| COVID-19 pneumoniaInfections and infestations | 52/9010 | 46/9027 |
| Atrial fibrillationCardiac disorders | 48/9010 | 48/9027 |
| COVID-19Infections and infestations | 42/9010 | 48/9027 |
Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
| Age, Continuous(years) | CSL112 | Placebo | Total |
|---|---|---|---|
| Mean | 65.6 ± 10.09 | 65.4 ± 10.21 | 65.5 ± 10.15 |
| Sex: Female, Male(Participants) | CSL112 | Placebo | Total |
|---|---|---|---|
| Female | 2326 | 2386 | 4712 |
| Male | 6786 | 6721 | 13507 |
| Ethnicity (NIH/OMB)(Participants) | CSL112 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1566 | 1596 | 3162 |
| Not Hispanic or Latino | 7410 | 7383 | 14793 |
| Unknown or Not Reported | 136 | 128 | 264 |
| Race (NIH/OMB)(Participants) | CSL112 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 51 | 36 | 87 |
| Asian | 743 | 781 | 1524 |
| Black or African American | 181 | 181 | 362 |
| Native Hawaiian or other Pacific Islander | 8 | 10 | 18 |
| White | 7769 | 7698 | 15467 |
| Multiracial or other | 314 | 356 | 670 |
| Not Reported by subject | 46 | 45 | 91 |
Showing the first 100 of 903 sites across 49 countries.
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CSL Behring