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

• ClinicalTrials.gov Identifier: NCT03473223
• Recruitment Status: Completed
• First Posted: March 22, 2018
• Last Update Posted: May 9, 2024
• Sponsor: CSL Behring
• Information provided by (Responsible Party): CSL Behring

Tracking Information

• First Submitted Date: March 14, 2018
• First Posted Date: March 22, 2018
• Last Update Posted Date: May 9, 2024
• Actual Study Start Date: March 21, 2018
• Actual Primary Completion Date: February 16, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2018)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 20, 2018)

• Key secondary outcome: Total number of hospitalizations for coronary, cerebral, or peripheral ischemia [ Time Frame: Through 90 days ]
• Key secondary outcome: Time to first occurrence of CV death, MI, or stroke [ Time Frame: Through 180 days ]
• Key secondary outcome: Time to first occurrence of CV death, MI, or stroke [ Time Frame: Through 365 days ]
• Time to occurrence of CV death [ Time Frame: Through 90 days ]
• Time to first occurrence of MI [ Time Frame: Through 90 days ]
• Time to first occurrence of stroke [ Time Frame: Through 90 days ]
• Time to occurrence of all-cause death [ Time Frame: Through 365 days ]
• Number of subjects with adverse events [ Time Frame: Through 90 days ]
• Percent of subjects with adverse events [ Time Frame: Through 90 days ]
• Number of subjects with treatment-related adverse events [ Time Frame: Through 365 days ]
• Percent of subjects with treatment-related adverse events [ Time Frame: Through 365 days ]
• Number of subjects with serious adverse events [ Time Frame: Through 365 days ]
• Percent of subjects with serious adverse events [ Time Frame: Through 365 days ]
• 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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Acute Coronary Syndrome

Intervention

• Biological: Apolipoprotein A-I [human] (apoA-I)
  Apolipoprotein A-I [human] (apoA-I) purified from human plasma for intravenous administration
  Other Name: CSL112
• Other: Placebo
  25% albumin solution diluted to 4.4%

Study Arms

• Experimental: CSL112
  Apolipoprotein A-I [human]
  Intervention: Biological: Apolipoprotein A-I [human] (apoA-I)
• Placebo Comparator: Placebo
  25% albumin solution diluted to 4.4%
  Intervention: Other: Placebo

• Publications *: Gibson CM, Duffy D, Korjian S, Bahit MC, Chi G, Alexander JH, Lincoff AM, Heise M, Tricoci P, Deckelbaum LI, Mears SJ, Nicolau JC, Lopes RD, Merkely B, Lewis BS, Cornel JH, Trebacz J, Parkhomenko A, Libby P, Sacks FM, Povsic TJ, Bonaca M, Goodman SG, Bhatt DL, Tendera M, Steg PG, Ridker PM, Aylward P, Kastelein JJP, Bode C, Mahaffey KW, Nicholls SJ, Pocock SJ, Mehran R, Harrington RA; AEGIS-II Committees and Investigators. Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction. N Engl J Med. 2024 May 2;390(17):1560-1571. doi: 10.1056/NEJMoa2400969. Epub 2024 Apr 6.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 1, 2022): 18200
• Original Estimated Enrollment (submitted: March 20, 2018): 17400
• Actual Study Completion Date: November 17, 2023
• Actual Primary Completion Date: February 16, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Administrative Information

• NCT Number: NCT03473223
• Other Study ID Numbers: CSL112_3001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CSL Behring
• Original Responsible Party: Same as current
• Current Study Sponsor: CSL Behring
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Danielle Duffy, MD; CSL Behring - Sr Global Clinical Program Dir - CV & Metabolism

• PRS Account: CSL Behring
• Verification Date: May 2024