NCT07118930RecruitingPhase 2
Study of Sivelestat Sodium in OPCABG
Prospective Double-Blind Controlled Study of Sivelestat Sodium in the Perioperative Management of Off-Pump Coronary Artery Bypass Grafting
Source: ClinicalTrials.gov · Last updated 12 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Affiliated Hospital of Nantong University
- Diseases
- Coronary artery disease
- NCT number
- NCT07118930
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 62
- From 1 Aug 2025 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency operation, combined valve surgery or aortic surgery. Usage of immunosuppressants or potent anti-inflammatory drugs within 30 days before the operation.
Other illness
- Active infections, autoimmune diseases, and allergy history.
- Severe cardiopulmonary insufficiency before the operation.
Other
- Preoperative liver and kidney dysfunction
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.