Study to Investigate CSL112 in Subjects with Acute Coronary Syndrome

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 - AEGIS-II / ApoA-I Event reducinG in Ischemic Syndromes II

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000996-98-LV

Enrollment

17400

Registered

2018-05-24

Start date

2018-08-03

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Apolipoprotein A-I [human] (apoA-I) purified from human plasma Product Code: CSL112 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: Apolipoprotein A-I [h

Apolipoprotein A-I , Apolipoprotein A1, Apo-AI, ApoA-I Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Solution for infusion Route

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female least 18 years of age 2. Evidence of myocardial necrosis, consistent with type (spontaneous) MI 3. No suspicion of acute kidney injury 4. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6960 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10440

Exclusion criteria

Exclusion criteria: 1. Ongoing hemodynamic instability 2. Evidence of hepatobiliary disease 3. Evidence of severe chronic kidney disease 4. Plan to undergo scheduled coronary artery bypass graft surgery 5. Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of CSL112 in reducing the risk of MACE [Major adverse cardiovascular event(s)][ (CV (cardiovascular)death, MI (Myocardial Infarction), or stroke)] in subjects with ACS (Acute Coronary Syndrome),[diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI(Non-ST-segment elevation myocardial infarction)]. ;Secondary Objective: 1. To evaluate the efficacy of CSL112 on reducing the total number of hospitalizations for coronary, cerebral, or peripheral ischemia. 2. To evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) in ACS (diagnosed with STEMI or NSTEMI) through 180 and 365 days ;Primary end point(s): Time to first occurrence of any component of composite MACE (CV death, MI, or stroke ) ;Timepoint(s) of evaluation of this end point: Through 90 days	—

Measure

Time frame

Main Objective: To evaluate the efficacy of CSL112 in reducing the risk of MACE [Major adverse cardiovascular event(s)][ (CV (cardiovascular)death, MI (Myocardial Infarction), or stroke)] in subjects with ACS (Acute Coronary Syndrome),[diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI(Non-ST-segment elevation myocardial infarction)]. ;Secondary Objective: 1. To evaluate the efficacy of CSL112 on reducing the total number of hospitalizations for coronary, cerebral, or peripheral ischemia. 2. To evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) in ACS (diagnosed with STEMI or NSTEMI) through 180 and 365 days ;Primary end point(s): Time to first occurrence of any component of composite MACE (CV death, MI, or stroke ) ;Timepoint(s) of evaluation of this end point: Through 90 days

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Total number of hospitalizations for coronary, cerebral, or peripheral ischemia 2) and 3) Time to first occurrence of CV death, MI, or stroke 4) Time to occurrence of CV death 5) Time to first occurrence of MI 6) Time to first occurrence of stroke 7) Time to occurrence of all-cause death 8) Number and percent of subjects with adverse events 9) Number and percent of subjects with treatment-related adverse events 10) Number and percent of subjects with serious adverse events 11) Number and 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);Timepoint(s) of evaluation of this end point: 1), 4), 5), 6), 8): Through 90 days 2): Through 180 days 3), 7), 9), 10): Through 365 days 11): Baseline and 29 days	—

Measure

Time frame

Secondary end point(s): 1) Total number of hospitalizations for coronary, cerebral, or peripheral ischemia 2) and 3) Time to first occurrence of CV death, MI, or stroke 4) Time to occurrence of CV death 5) Time to first occurrence of MI 6) Time to first occurrence of stroke 7) Time to occurrence of all-cause death 8) Number and percent of subjects with adverse events 9) Number and percent of subjects with treatment-related adverse events 10) Number and percent of subjects with serious adverse events 11) Number and 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);Timepoint(s) of evaluation of this end point: 1), 4), 5), 6), 8): Through 90 days 2): Through 180 days 3), 7), 9), 10): Through 365 days 11): Baseline and 29 days

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Estonia, European Union, Finland, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Registration Coordinator

CSL Behring LLC

clinicaltrials@cslbehring.com+1484-878-4000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026