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Study of Sivelestat Sodium in OPCABG

RECRUITINGPhase 2Sponsored by Affiliated Hospital of Nantong University
Actively Recruiting
PhasePhase 2
SponsorAffiliated Hospital of Nantong University
Started2025-08-01
Est. completion2027-07-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions4

Coronary Arterial Disease (CAD)Coronary Artery DiseaseCoronary Heart DiseaseHeart Disease

Interventions2

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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