Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

Phase 3

Completed

Conditions: Acute Coronary Syndrome

Interventions: Other: Placebo
Biological: Apolipoprotein A-I [human] (apoA-I)

Registration Number: NCT03473223

Lead Sponsor: CSL Behring

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18226

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	25% albumin solution diluted to 4.4%
CSL112	Apolipoprotein A-I [human] (apoA-I)	Apolipoprotein A-I \[human\]

Primary Outcome Measures

Name	Time	Method
Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)	From the time of randomization through 90 days	MACE (Major adverse cardiovascular event\[s\])(CV \[cardiovascular\] death, MI \[Myocardial Infarction\], or stroke).

Secondary Outcome Measures

Name	Time	Method
Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia	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.
Number of Participants With First Occurrence of CV Death, MI, or Stroke	From the time of randomization through 365 days
Number of Participants With Occurrence of CV Death	From the time of randomization through 90 days
Number of Participants With First Occurrence of MI	From the time of randomization through 90 days
Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke	From the time of randomization through 90, 180 and 365 days
Number of Participants With Occurrence of All-cause Death	From the time of randomization through 365 days
Number of Participants With Adverse Events	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.
Percentage of Participants With Adverse Events	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.
Change From Baseline in Renal Parameter: Serum Creatinine	From Baseline to Day 29
Number of Participants With Treatment-related Adverse Events	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.
Percentage of Participants With SAEs	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.
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments	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.
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments	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.
Change From Baseline in Hematology Parameter: Hematocrit	From Baseline to Day 29
Change From Baseline in Hematology Parameter: Hemoglobin	From Baseline to Day 29
Change From Baseline in Hepatic Parameters	From Baseline to Day 29	Hepatic parameters included ALT, ALP and AST.
Change From Baseline in Hepatic Parameter: Bilirubin	From Baseline to Day 29
Percentage of Participants With Treatment-related Adverse Events	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.
Number of Participants With Serious Adverse Events (SAEs)	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.
Change From Baseline in Hematology Parameters	From Baseline to Day 29	Hematology parameters included Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets.
Change From Baseline in Renal Parameter: Blood Urea Nitrogen	From Baseline to Day 29
Change From Baseline in Renal Parameter: eGFR	From Baseline to Day 29
Number of Participants With First Occurrence of Stroke	From the time of randomization through 90 days

Trial Locations

Locations (903): 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
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8400896 - Advanced Cardiovascular LLC
🇺🇸Alexander City, Alabama, United States