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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 : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE March 22, 2018
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE March 21, 2018
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03473223 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • 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  ICMJE
  • 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 * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
17400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and at least 1 of the following established risk factors:age ≥ 65 years, prior history of MI, diabetes mellitus,or peripheral artery 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
  • Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czechia,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03473223
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party CSL Behring
Study Sponsor  ICMJE CSL Behring
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Danielle Duffy, MD CSL Behring - Sr Global Clinical Program Dir - CV & Metabolism
PRS Account CSL Behring
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP