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

CSL Behring903 sites in 1 country18,226 target enrollmentMarch 21, 2018

ConditionsAcute Coronary Syndrome

InterventionsApolipoprotein A-I [human] (apoA-I)Placebo

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

Overview

Phase: Phase 3
Intervention: Apolipoprotein A-I [human] (apoA-I)
Conditions: Acute Coronary Syndrome
Sponsor: CSL Behring
Enrollment: 18226
Locations: 903
Primary Endpoint: Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 21, 2018

End Date

November 17, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSL Behring

Responsible Party

Sponsor

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):
•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

Arms & Interventions

CSL112

Apolipoprotein A-I \[human\]

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

Placebo

25% albumin solution diluted to 4.4%

Intervention: Placebo

Outcomes

Primary Outcomes

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

Change From Baseline in Renal Parameter: eGFR(From Baseline to Day 29)
Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia(From the time of randomization through 90 days)
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 Stroke(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)
Percentage of Participants With Adverse Events(From the start of treatment through 90 days)
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))
Percentage of Participants With SAEs(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(Baseline and 29 days)
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments(Baseline and 29 days)
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)
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))
Number of Participants With Serious Adverse Events (SAEs)(From the start of treatment through 379 days (Day 365 + 14 days of follow up))
Change From Baseline in Hematology Parameters(From Baseline to Day 29)
Change From Baseline in Renal Parameter: Blood Urea Nitrogen(From Baseline to Day 29)