Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Purpose
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
- Acute Coronary Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CSL112 |
Apolipoprotein A-I [human] |
|
|
Placebo Comparator Placebo |
25% albumin solution diluted to 4.4% |
|
More Details
- Status
- Completed
- Sponsor
- CSL Behring