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Clinical Trials in China / NCT07118930
Recruiting Phase 2

Study of Sivelestat Sodium in OPCABG

NCT07118930 · tracked via the Priya Life Science China tracker
Sponsor
Affiliated Hospital of Nantong University
Phase
Phase 2
Started
2025-08-01
Last updated
2025-08-12

Condition(s) studied

Coronary Heart DiseaseCoronary Artery DiseaseCoronary Arterial Disease (CAD)

Investigational drug(s) / intervention(s)

Sivelestat Sodium injection 2 h after OPCABG for 72 hSaline (0.9% NaCl)

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

Saline (0.9% NaCl): Saline (0.9% NaCl) instead of Sivelestat

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Nantong University Nantong Jiangsu Recruiting

More Affiliated Hospital of Nantong University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07118930 on ClinicalTrials.gov ↗ ← All trials in China