Actively Recruiting
Study of Sivelestat Sodium in OPCABG
Led by Affiliated Hospital of Nantong University · Updated on 2025-08-12
62
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Sivelestat Sodium in OPCABG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Undergoing elective off-pump coronary artery bypass grafting with at least two bypass vessels
- Left ventricular ejection fraction of 35% or higher
- No severe liver or kidney abnormalities (ALT/AST less than or equal to 3 times the upper limit, eGFR 60 mL/min or higher)
- Signed informed consent form
You will not qualify if you...
- Emergency surgery or combined valve or aortic surgery
- Use of immunosuppressants or strong anti-inflammatory drugs within 30 days before surgery
- Active infection, autoimmune disease, or allergy history
- Liver or kidney dysfunction before surgery
- Severe cardiopulmonary insufficiency before surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
W
Weizhang Xiao, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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