AEGIS II_CSL112_3001
| 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 Period |
| responsible person | Dr.Hans Rickli, Susanne Vetsch |