Kantonsspital St.Gallen

AEGIS II_CSL112_3001

Susanne Vetsch

abstract 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
type of project clinical studies
status aborted
start of project 2019
end of project 2020
study design This is a phase 3 multicenter, double-blind, randomized, placebo-controlled, parallel-group
study designed to evaluate the efficacy and safety of CSL112 on reducing the risk of MACE
in subjects with ACS (diagnosed with STEMI or NSTEMI) who are receiving evidence-based
medical therapy.
Subjects will be screened and, if eligible, stratified at baseline by index MI type (STEMI vs
NSTEMI), management of the index MI (PCI vs medically managed), and region (North
America, Latin America, Western Europe, Central and Eastern Europe, or Asia Pacific). The
study will enroll approximately 17,400 subjects with recent MI, up to a maximum of
approximately 20,600 subjects, who will be randomized with equal allocation (1:1 ratio) to 1
of 2 treatment groups (CSL112 6 g or placebo).
The study is planned to be conducted at approximately 1000 sites. The estimated study
duration is approximately 50 months.
The study will consist of a Screening Period, an Active Treatment Period, and a Follow-up
responsible person Dr.Hans Rickli, Susanne Vetsch