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RECRUITING
NCT07118930
PHASE2

Study of Sivelestat Sodium in OPCABG

Sponsor: Affiliated Hospital of Nantong University

View on ClinicalTrials.gov

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.

Official title: Prospective Double-Blind Controlled Study of Sivelestat Sodium in the Perioperative Management of Off-Pump Coronary Artery Bypass Grafting

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2025-08-01

Completion Date

2027-07-31

Last Updated

2025-08-12

Healthy Volunteers

No

Interventions

DRUG

Sivelestat Sodium injection 2 h after OPCABG for 72 h

Sivelestat Sodium injection 2 h after OPCABG for 72 h

DRUG

Saline (0.9% NaCl)

Saline (0.9% NaCl) instead of Sivelestat

Locations (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China