Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes I)
Authors' conclusion
Among patients with acute myocardial infarction, 4 weekly infusions of CSL112 are feasible, well tolerated, and not associated with any significant alterations in liver or kidney function or other safety concern. The ability of CSL112 to acutely enhance cholesterol efflux was confirmed.
Study context
- Population
- Patients with recent acute MI91.2% received all 4 infusions
- Participants
- 1,258 patients
- Comparison
- CSL112 vs placebo, 4 weekly infusions
- Primary endpoint
- Coprimary safety: hepatic safety event (ALT >3× ULN or total bilirubin >2× ULN) or renal safety event (serum creatinine >1.5× baseline or new renal replacement therapy)
Methodological detailsmulticentre, double-blind, placebo-controlled, dose-ranging, phase 2b, non-inferiority
- Multicentre
- Double-blind
- Placebo-controlled
- Dose-ranging
- Phase 2b
- Non-inferiority
Primary result
As reported in the abstract
- Difference in hepatic event (ALT or bilirubin increase) rates, both CSL112 arms vs placebo, within non-inferiority margin of 4%
- Difference in renal event (creatinine increase or new renal replacement therapy) rates within non-inferiority margin of 5%
- Non-inferiority margins 4% (hepatic) and 5% (renal), protocol-defined; non-inferiority met
Secondary outcomes
MACE (secondary efficacy end point)
- Risk similar among groups
ApoA-I and ex vivo cholesterol efflux
- CSL112 increased apolipoprotein A-I (apoA-I) and cholesterol efflux, similar to stable CAD
Original publication
Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes I). Circulation. Published 15 November 2016. doi:10.
Summarised from the published abstract; every number is checked against it