Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Summary
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.
Timeline
- Start
- 2018-03-21
- Primary completion
- 2023-02-16
- Completion
- 2023-11-17
Outcome
Missed primary endpoint
registry analysis (superiority test); CSL112 vs Placebo; p = 0.121; Hazard Ratio (HR) 0.925 (95% CI 0.8126 to 1.0538) NCT03473223 ↗
paper did not significantly reduce the first occurrence of CV death, myocardial infarction (MI), or stroke through 90 days compared with placebo. PMID 39230545 ↗
Publications
- Background Gibson CM, Duffy D, Korjian S, Bahit MC, Chi G, Alexander JH, Lincoff AM, Heise M, Tricoci P, Deckelbaum LI, Mears SJ, Nicolau JC, Lopes RD, Merkely B, Lewis BS, Cornel JH, Trebacz J, Parkhomenko A, Libby P, Sacks FM, Povsic TJ, Bonaca M, Goodman SG, Bhatt DL, Tendera M, Steg PG, Ridker PM, Aylward P, Kastelein JJP, Bode C, Mahaffey KW, Nicholls SJ, Pocock SJ, Mehran R, Harrington RA; AEGIS-II Committees and Investigators. Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction. N Engl J Med. 2024 May 2;390(17):1560-1571. doi: 10.1056/NEJMoa2400969. Epub 2024 Apr 6.
- Background Povsic TJ, Korjian S, Bahit MC, Chi G, Duffy D, Alexander JH, Vinereanu D, Tricoci P, Mears SJ, Deckelbaum LI, Bonaca M, Ridker PM, Goodman SG, Cornel JH, Lewis BS, Parkhomenko A, Lopes RD, Aylward P, Lincoff AM, Heise M, Sacks F, Nicolau JC, Merkely B, Trebacz J, Libby P, Nicholls SJ, Pocock S, Bhatt DL, Kastelein J, Bode C, Mahaffey KW, Steg PG, Tendera M, Bainey KR, Harrington RA, Mehran R, Duerschmied D, Kingwell BA, Gibson CM; AEGIS-II Committees and Investigators. Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI. J Am Coll Cardiol. 2024 Jun 4;83(22):2163-2174. doi: 10.1016/j.jacc.2024.03.396. Epub 2024 Apr 6.
- Gibson CM, Chi G, Duffy D, Bahit MC, White H, Korjian S, Alexander JH, Lincoff AM, Anschuetz G, Girgis IG, Nicolau JC, Lopes RD, Cornel JH, Bainey KR, Libby P, Sacks FM, Ridker PM, Goodman SG, Mahaffey KW, Nicholls SJ, Pocock SJ, Mehran R, Harrington RA; AEGIS-II Committees and Investigators. ApoA-I Infusions and Burden of Ischemic Events After Acute Myocardial Infarction: Insights From the AEGIS-II Trial. J Am Coll Cardiol. 2024 Nov 26;84(22):2185-2192. doi: 10.1016/j.jacc.2024.08.001. Epub 2024 Sep 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apolipoprotein A-I [human] | Protein / enzyme biologic | 6 g | Intravenous |