AEGIS-II / ApoA-I Event reducinG in Ischemic Syndromes II
Research type
Research Study
Full title
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
IRAS ID
243165
Contact name
Vijay Kunadian
Contact email
Sponsor organisation
CSL Behring LLC
Eudract number
2017-000996-98
Duration of Study in the UK
4 years, 1 months, 1 days
Research summary
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the effectiveness and safety of CSL112 on reducing the risk of major adverse cardio vascular events. A 6 gram dose of CSL112 will be compared to placebo (Albumin).
Approximately 17,000 patients will take part in this study in hospitals around the world, of these approximately 250 will be in the UK. Participation in the study will be approximately 1 year, (365 days). This includes the Screening Period (1 visit), an Active Treatment Period (which includes 4 weekly infusion visits and a follow-up visit for safety) and a Follow-Up Period (which includes 5 visits) to assess any new health problems or side effects patients may have experienced since their last study visit and their overall well-being. This study will have 11 study visits, 2 of which may be conducted by telephone during the Follow-Up period.REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0190
Date of REC Opinion
5 Sep 2018
REC opinion
Further Information Favourable Opinion