CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 18,226 enrolled
Drug / intervention
Apolipoprotein A-I [human] (apoA-I) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03473223
NCT03473223Phase 3Completed
CompareCT.gov

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

CSL Behring·interventional·Posted Mar 22, 2018·Updated Jan 14, 2025

In Brief

A Phase 3 clinical trial evaluating Apolipoprotein A-I [human] (apoA-I) and Placebo for Acute Coronary Syndrome. Completed, enrolled 18,226 participants across 903 sites in 49 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 22, 2018
Enrollment StartMar 21, 2018
Primary CompletionFeb 16, 2023
Study CompletionNov 17, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.3 years ago

Interventions

Apolipoprotein A-I [human] (apoA-I)biological

Apolipoprotein A-I \[human\] (apoA-I) purified from human plasma for intravenous administration

Placeboother

25% albumin solution diluted to 4.4%