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.
Brief Title
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Coronary Syndrome
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Coronary Artery Disease
Heart Disease
Cardiovascular Disease
Acute Myocardial Infarction
Heart Failure
Major adverse cardiovascular event
Multivessel disease
Peripheral artery disease
Cerebrovascular accident
Ischemic stroke
Hemorrhagic stroke
Atherosclerosis
Congestive heart failure
Valvular heart disease
Atrial Fibrillation
Hypertension
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03473223
Org Class
Industry
Org Full Name
CSL Behring
Org Study Id
CSL112_3001
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official 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
Primary Outcomes
Outcome Description
MACE (Major adverse cardiovascular event\[s\])(CV \[cardiovascular\] death, MI \[Myocardial Infarction\], or stroke).
Outcome Measure
Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)
Outcome Time Frame
From the time of randomization through 90 days
Secondary Ids
Secondary Id
2017-000996-98
Secondary Outcomes
Outcome Description
The total number of hospitalizations and individual hospitalizations due to coronary, cerebral, and peripheral ischemia were reported.
Outcome Time Frame
From the time of randomization through 90 days
Outcome Measure
Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia
Outcome Time Frame
From the time of randomization through 180 days
Outcome Measure
Number of Participants With First Occurrence of CV Death, MI, or Stroke
Outcome Time Frame
From the time of randomization through 365 days
Outcome Measure
Number of Participants With First Occurrence of CV Death, MI, or Stroke
Outcome Time Frame
From the time of randomization through 90 days
Outcome Measure
Number of Participants With Occurrence of CV Death
Outcome Time Frame
From the time of randomization through 90 days
Outcome Measure
Number of Participants With First Occurrence of MI
Outcome Time Frame
From the time of randomization through 90 days
Outcome Measure
Number of Participants With First Occurrence of Stroke
Outcome Time Frame
From the time of randomization through 90, 180 and 365 days
Outcome Measure
Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke
Outcome Time Frame
From the time of randomization through 365 days
Outcome Measure
Number of Participants With Occurrence of All-cause Death
Outcome Description
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.
Outcome Time Frame
From the start of treatment through 90 days
Outcome Measure
Number of Participants With Adverse Events
Outcome Description
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.
Outcome Time Frame
From the start of treatment through 90 days
Outcome Measure
Percentage of Participants With Adverse Events
Outcome Description
Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product.
Outcome Time Frame
From the start of treatment through 379 days (Day 365 + 14 days of follow up)
Outcome Measure
Number of Participants With Treatment-related Adverse Events
Outcome Description
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.
Outcome Time Frame
From the start of treatment through 379 days (Day 365 + 14 days of follow up)
Outcome Measure
Percentage of Participants With Treatment-related Adverse Events
Outcome Description
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.
Outcome Time Frame
From the start of treatment through 379 days (Day 365 + 14 days of follow up)
Outcome Measure
Number of Participants With Serious Adverse Events (SAEs)
Outcome Description
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.
Outcome Time Frame
From the start of treatment through 379 days (Day 365 + 14 days of follow up)
Outcome Measure
Percentage of Participants With SAEs
Outcome Description
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.
Outcome Time Frame
Baseline and 29 days
Outcome Measure
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments
Outcome Description
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.
Outcome Time Frame
Baseline and 29 days
Outcome Measure
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments
Outcome Description
Hematology parameters included Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets.
Outcome Time Frame
From Baseline to Day 29
Outcome Measure
Change From Baseline in Hematology Parameters
Outcome Time Frame
From Baseline to Day 29
Outcome Measure
Change From Baseline in Hematology Parameter: Hematocrit
Outcome Time Frame
From Baseline to Day 29
Outcome Measure
Change From Baseline in Hematology Parameter: Hemoglobin
Outcome Description
Hepatic parameters included ALT, ALP and AST.
Outcome Time Frame
From Baseline to Day 29
Outcome Measure
Change From Baseline in Hepatic Parameters
Outcome Time Frame
From Baseline to Day 29
Outcome Measure
Change From Baseline in Hepatic Parameter: Bilirubin
Outcome Time Frame
From Baseline to Day 29
Outcome Measure
Change From Baseline in Renal Parameter: Serum Creatinine
Outcome Time Frame
From Baseline to Day 29
Outcome Measure
Change From Baseline in Renal Parameter: eGFR
Outcome Time Frame
From Baseline to Day 29
Outcome Measure
Change From Baseline in Renal Parameter: Blood Urea Nitrogen
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Anna Bortnick
Investigator Email
abortnic@montefiore.org
Investigator Phone
718 904 3457