NCT07118930 Study of Sivelestat Sodium in OPCABG
| NCT ID | NCT07118930 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Affiliated Hospital of Nantong University |
| Condition | Coronary Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 62 participants in total. It began in 2025-08-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Weizhang Xiao, Dr.
STUDY CHAIR
Affiliated Hospital of Nantong University
Frequently Asked Questions
Who can join the NCT07118930 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Coronary Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07118930 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07118930 currently recruiting?
Yes, NCT07118930 is actively recruiting participants. Contact the research team at xwz191201@163.com for enrollment information.
Where is the NCT07118930 trial being conducted?
This trial is being conducted at Nantong, China.
Who is sponsoring the NCT07118930 clinical trial?
NCT07118930 is sponsored by Affiliated Hospital of Nantong University. The principal investigator is Weizhang Xiao, Dr. at Affiliated Hospital of Nantong University. The trial plans to enroll 62 participants.