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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224998

Enrollment

18200

Registered

2019-12-24

Start date

2020-02-21

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Acute coronary syndrome Acute coronary syndrome is a life-threatening condition, which most commonly occurs when an atherosclerotic plaque ruptures or erodes, leading to thrombus formation within a coronary artery.

Interventions

investigational material(s) Generic name etc : Apolipoprotein A-I [human] (apoA-I) purified from human plasma INN of investigational material : - Therapeutic category code : 634 Human blood preparatio

approximately 170 mL) will be IV infused in a vein (peripheral or central) over 2 hours. control material(s) Generic name etc : Placebo, 25% albumin solution diluted to 4.4% INN of investigational ma

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 1 (spontaneous) MI 3. No suspicion of acute kidney injury 4. Evidence of multivessel coronary artery disease 5. Presence of established cardiovascular risk factor(s): a. Diabetes mellitus on pharmacotherapy OR b. 2 or more of the following: age greater or equal to 65 years, prior history of MI, peripheral arterial disease

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 as treatment for the index MI 5. Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin

Design outcomes

Primary

Measure	Time frame
efficacy The primary endpoint is time to first occurrence of any component of the composite MACE, defined as CV death, MI, or stroke from the time of randomization through 90 days. The primary endpoint will include all MIs.	—

Secondary

Measure	Time frame
efficacy 1. Total number of hospitalizations for coronary, cerebral, or peripheral ischemia from the time of randomization through 90 days. 2. Time to first occurrence of CV death, MI, or stroke from the time of randomization through 180 days. 3. Time to first occurrence of CV death, MI, or stroke from the time of randomization through 365 days.	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026