ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03473223
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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 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 : October 2021
Estimated Study Completion Date : June 2022

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 intraveneous administration
Other Name: CSL112

Placebo Comparator: Placebo
25% albumin solution diluted to 4.4%
Other: Placebo
25% albumin solution diluted to 4.4%




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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

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

  Show 24 Study Locations
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Gail Berman CSL Behring - Director, Medical Affairs Cardiovascular

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03473223     History of Changes
Other Study ID Numbers: CSL112_3001
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases