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Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome (AEGIS-II)

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ClinicalTrials.gov Identifier: NCT03473223
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Biological: Apolipoprotein A-I [human] (apoA-I) Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : April 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: CSL112
Apolipoprotein A-I [human]
 Biological: Apolipoprotein A-I [human] (apoA-I)
Apolipoprotein A-I [human] (apoA-I) purified from human plasma for intravenous administration
Other Name: CSL112
Placebo Comparator: Placebo
25% albumin solution diluted to 4.4%
 Other: Placebo
25% albumin solution diluted to 4.4%


Outcome Measures
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Primary Outcome Measures :
  1. Time to first occurrence of any component of composite MACE (CV death, MI, or stroke ) [ Time Frame: Through 90 days ]
    MACE [Major adverse cardiovascular event(s)][ (CV (cardiovascular)death, MI (Myocardial Infarction), or stroke)


Secondary Outcome Measures :
  1. Key secondary outcome: Total number of hospitalizations for coronary, cerebral, or peripheral ischemia [ Time Frame: Through 90 days ]
  2. Key secondary outcome: Time to first occurrence of CV death, MI, or stroke [ Time Frame: Through 180 days ]
  3. Key secondary outcome: Time to first occurrence of CV death, MI, or stroke [ Time Frame: Through 365 days ]
  4. Time to occurrence of CV death [ Time Frame: Through 90 days ]
  5. Time to first occurrence of MI [ Time Frame: Through 90 days ]
  6. Time to first occurrence of stroke [ Time Frame: Through 90 days ]
  7. Time to occurrence of all-cause death [ Time Frame: Through 365 days ]
  8. Number of subjects with adverse events [ Time Frame: Through 90 days ]
  9. Percent of subjects with adverse events [ Time Frame: Through 90 days ]
  10. Number of subjects with treatment-related adverse events [ Time Frame: Through 365 days ]
  11. Percent of subjects with treatment-related adverse events [ Time Frame: Through 365 days ]
  12. Number of subjects with serious adverse events [ Time Frame: Through 365 days ]
  13. Percent of subjects with serious adverse events [ Time Frame: Through 365 days ]
  14. Number of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low) [ Time Frame: Baseline and 29 days ]
  15. Percent of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low) [ Time Frame: Baseline and 29 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473223


Contacts
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Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
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Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Danielle Duffy, MD CSL Behring - Sr Global Clinical Program Dir - CV & Metabolism
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03473223    
Other Study ID Numbers: CSL112_3001
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases