Study of Sivelestat Sodium in OPCABG
Recruiting now · Phase 2
Conditions studied: Coronary Heart Disease, Coronary Artery Disease, Coronary Arterial Disease (CAD)
In brief
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.
Key facts
- Study ID
- NCT07118930
- Run by
- Affiliated Hospital of Nantong University
- People needed
- 62
- Starts
- 2025-08-01
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2025-08-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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