Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Completed · Phase 3 · Has a placebo group
Conditions studied: Acute Coronary Syndrome
In brief
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.
Key facts
- Study ID
- NCT03473223
- Run by
- CSL Behring
- People needed
- 18226
- Starts
- 2018-03-21
- Expected to finish
- 2023-11-17
- Last updated by the study team
- 2025-01-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 8400350 - Cardiology, PC — Birmingham, Alabama, United States
- 8400337 - Heart Center Research, LLC — Huntsville, Alabama, United States
- 8400713 - University of South Alabama College of Medicine — Mobile, Alabama, United States
- 8400556 - Mercy Gilbert Medical Center — Gilbert, Arizona, United States
- 8400747 - Phoenix V.A. Health Care System — Phoenix, Arizona, United States
- 8400772 - Mayo Clinic Arizona — Phoenix, Arizona, United States
- 8400996 - Southern Arizona V.A. Healthcare System — Tucson, Arizona, United States
- 8400645 - NEA Baptist Clinic — Jonesboro, Arkansas, United States
- 8400975 - Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
- 8401054 - Central Cardiology Medical Center — Bakersfield, California, United States
- 8400379 - John Muir Health and Cardiovascular Institute — Concord, California, United States
- 8400931 - Valley Clinical Trials — Covina, California, United States
- 8401103 - Orange Coast Memorial Hospital — Fountain Valley, California, United States
- 8401166 - Sharp Grossmont Hospital — La Mesa, California, United States
- 8401192 - South Orange County Surgical Medical Group — Laguna Hills, California, United States
- 8400596 - Long Beach Memorial Medical Center — Long Beach, California, United States
- 8400910 - Cardiovascular Innovation and Research Center — Long Beach, California, United States
- 8400597 - Los Alamitos Cardiovascular — Los Alamitos, California, United States
- 8400693 - University of California Los Angeles — Los Angeles, California, United States
- 8400717 - V.A. Greater Los Angeles Healthcare System — Los Angeles, California, United States
- 8400888 - Saint Jude Heritage Healthcare — Mission Viejo, California, United States
- 8400745 - Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
- 8400658 - Valley Clinical Trials, Inc. — Northridge, California, United States
- 8400720 - Valley Clinical Trials — Pasadena, California, United States
- 8400896 - Advanced Cardiovascular LLC — Alexander City, Alabama, United States
Full record on ClinicalTrials.gov
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