Alexander City, Alabama 35010

  • 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.


Criteria:

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


NCT ID:

NCT03473223


Primary Contact:

Study Director
Danielle Duffy, MD
CSL Behring - Sr Global Clinical Program Dir - CV & Metabolism

Trial Registration Coordinator
Phone: 610-878-4000
Email: clinicaltrials@cslbehring.com


Backup Contact:

N/A


Location Contact:

Alexander City, Alabama 35010
United States

Use Central Contact

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 15, 2021

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