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

CSL Behring

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Other: Placebo; Biological: Apolipoprotein A-I [human] (apoA-I)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03473223

CSL112_3001

2017-000996-98 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 18,226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18,226 participants in 2 patient groups, including a placebo group

CSL112

Experimental group

Description:

Apolipoprotein A-I \[human\]

Treatment:

Biological: Apolipoprotein A-I [human] (apoA-I)

Placebo

Placebo Comparator group

Description:

25% albumin solution diluted to 4.4%

Treatment:

Other: Placebo