Clinical Trial

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

Dimensions: NCT03473223

Investigators

Affiliations

Organisations

  1. (1) CSL (United States), grid.428413.8

Sponsors/collaborators

Abstract

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.

Methods

Condition: Acute Coronary Syndrome

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

Recruitment information

Gender: All

Trial period

2018-2023

Phase

Phase 3

Research Categories

Main Subject Area

Fields of Research

External sources

Access at Registry