NCT03473223

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18,226 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Apolipoprotein A-I [human] (apoA-I)	Apolipoprotein A-I \[human\] (apoA-I) purified from human plasma for intravenous administration
OTHER	Placebo	25% albumin solution diluted to 4.4%

Timeline

• Start date: 2018-03-21
• Primary completion: 2023-02-16
• Completion: 2023-11-17
• First posted: 2018-03-22
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

903 sites across 49 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study