NCT07118930

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
15mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Aug 2025Jul 2027

First Submitted

Initial submission to the registry

August 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

August 12, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

August 1, 2025

Last Update Submit

August 11, 2025

Conditions

Coronary Heart DiseaseCoronary Artery DiseaseCoronary Arterial Disease (CAD)

Keywords

coronary heart diseasecoronary artery bypass graftingSivelestat Sodiumprognosismyocardial injury

Outcome Measures

Primary Outcomes (1)

  • Myocardial injury

    Sivelestat Sodium exerts a protective effect on myocardial injury after OPCABG

    Day 3 after OPCABG

Secondary Outcomes (1)

  • Myocardial inflammatory stress

    Day 3 after OPCABG

Study Arms (2)

Sivelestat Sodium

EXPERIMENTAL

Sivelestat Sodium injection or a placebo 2 h after OPCABG for 72 h

Drug: Sivelestat Sodium injection 2 h after OPCABG for 72 h

Routine therapy

PLACEBO COMPARATOR

Saline instead of Sivelestat

Drug: Saline (0.9% NaCl)

Interventions

Sivelestat Sodium injection 2 h after OPCABG for 72 hDRUG

Sivelestat Sodium injection 2 h after OPCABG for 72 h

Sivelestat Sodium
Saline (0.9% NaCl)DRUG

Saline (0.9% NaCl) instead of Sivelestat

Routine therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing elective OPCABG (≥2 bridged vessels). LVEF≥35%, no severe liver or kidney function abnormalities (ALT/AST≤3 times the upper limit, eGFR≥60 mL/min). Sign the informed consent form.

You may not qualify if:

  • Emergency operation, combined valve surgery or aortic surgery. Usage of immunosuppressants or potent anti-inflammatory drugs within 30 days before the operation.
  • Active infections, autoimmune diseases, and allergy history.
  • Preoperative liver and kidney dysfunction
  • Severe cardiopulmonary insufficiency before the operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 35266173RESULT

  • 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.

    PMID: 36389323RESULT

  • 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.

    PMID: 31813921RESULT

  • 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.

    PMID: 20464430RESULT

  • 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.

    PMID: 38769746RESULT

  • 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.

    PMID: 38886709RESULT

  • 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.

    PMID: 24241342RESULT

  • 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.

    PMID: 12595539RESULT

  • 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):e87315. doi: 10.1172/jci.insight.87315.

    PMID: 27536731RESULT

  • 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.

    PMID: 38811097RESULT

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery Disease

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Weizhang Xiao, Dr.

    Affiliated Hospital of Nantong University

    STUDY CHAIR

Central Study Contacts

Weizhang Xiao, Dr.

CONTACT

8615996546951xwz191201@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 12, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

August 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Basic information, type of operation, experimental results

Shared Documents
STUDY PROTOCOL, SAP

Locations

CN(1)