Study of Sivelestat Sodium in OPCABG

Summary

The goal of this clinical trial is to learn if drug Sivelestat Sodium works to improve the prognosis of off-pump coronary artery bypass grafting (OPCABG) in adults. It will also learn about the safety of drug Sivelestat Sodium. The main questions it aims to answer are: * Does drug Sivelestat Sodium have a protective effect on myocardial injury after OPCABG? * Does Sivelestat Sodium exert a protective effect on myocardial inflammatory stress after OPCABG? Researchers will compare drug Sivelestat Sodium to a placebo (a look-alike substance that contains no drug) to see if drug Sivelestat Sodium works to protect myocardium following OPCABG. Participants will: * Accept drug Sivelestat Sodium injection or a placebo 2 h after OPCABG for 72 h. * Undergo a series of blood tests and echocardiography examinations after the OPCABG.

Timeline

Start

2025-08-01

Primary completion

2027-07-31

Completion

2027-07-31

Publications

• Results Sun L, Zhou M, Ji Y, Wang X, Wang X. Off-pump versus on-pump coronary artery bypass grafting for octogenarians: A meta-analysis involving 146 372 patients. Clin Cardiol. 2022 Apr;45(4):331-341. doi: 10.1002/clc.23794. Epub 2022 Mar 10.
• Results Zhou Y, Li X, Chen H, Zhong X, Ren H. Efficacy and safety of sivelestat sodium for the treatment of inflammatory response in acute Stanford type A aortic dissection: a retrospective cohort study. J Thorac Dis. 2022 Oct;14(10):3975-3982. doi: 10.21037/jtd-22-1220.
• Results Fujii M, Bessho R. Neutrophil Elastase Inhibitor Sivelestat Attenuates Myocardial Injury after Cardioplegic Arrest in Rat Hearts. Ann Thorac Cardiovasc Surg. 2020 Oct 21;26(5):263-269. doi: 10.5761/atcs.oa.19-00240. Epub 2019 Dec 9.
• Results Akiyama D, Hara T, Yoshitomi O, Maekawa T, Cho S, Sumikawa K. Postischemic infusion of sivelestat sodium hydrate, a selective neutrophil elastase inhibitor, protects against myocardial stunning in swine. J Anesth. 2010 Aug;24(4):575-81. doi: 10.1007/s00540-010-0948-8. Epub 2010 May 13.
• Results Sun JK, Li JJ, Deng YH, Yin X, Huangfu XT, Ye ZY, Zhou XH, Chen YM, Yuan ST, Wang X. The beneficial effects of neutrophil elastase inhibitor on gastrointestinal dysfunction in sepsis. Clin Transl Sci. 2024 May;17(5):e13829. doi: 10.1111/cts.13829.
• Results Xu J, Zhang C, Wu K, Qian Y, Hu W. A comparative analysis of sivelestat sodium hydrate and ulinastatin combination therapy in the treatment of sepsis with acute respiratory distress syndrome. BMC Pulm Med. 2024 Jun 17;24(1):283. doi: 10.1186/s12890-024-03083-w.
• Results Henriksen PA. The potential of neutrophil elastase inhibitors as anti-inflammatory therapies. Curr Opin Hematol. 2014 Jan;21(1):23-8. doi: 10.1097/MOH.0000000000000001.
• Results Yu X, Kennedy RH, Liu SJ. JAK2/STAT3, not ERK1/2, mediates interleukin-6-induced activation of inducible nitric-oxide synthase and decrease in contractility of adult ventricular myocytes. J Biol Chem. 2003 May 2;278(18):16304-9. doi: 10.1074/jbc.M212321200. Epub 2003 Feb 20.
• Results Li W, Hsiao HM, Higashikubo R, Saunders BT, Bharat A, Goldstein DR, Krupnick AS, Gelman AE, Lavine KJ, Kreisel D. Heart-resident CCR2+ macrophages promote neutrophil extravasation through TLR9/MyD88/CXCL5 signaling. JCI Insight. 2016 Aug 4;1(12):87315. doi: 10.1172/jci.insight.87315.
• Results Welt FGP, Batchelor W, Spears JR, Penna C, Pagliaro P, Ibanez B, Drakos SG, Dangas G, Kapur NK. Reperfusion Injury in Patients With Acute Myocardial Infarction: JACC Scientific Statement. J Am Coll Cardiol. 2024 Jun 4;83(22):2196-2213. doi: 10.1016/j.jacc.2024.02.056.

Drugs

Indications