Open
Actively Recruiting
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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):
- Diabetes mellitus on pharmacotherapy OR
- 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
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Study Stats
Protocol No.
18-001287
Category
Cardiology
Principal Investigator
Contact
Location
- UCLA Westwood