Clinical Efficacy of Inclisiran in Preventing Postoperative Complications in Patients Undergoing Coronary Artery Bypass Grafting

Clinical Evaluation of the Efficacy of Inclisiran in Preventing Postoperative Complications in Patients Undergoing CABG

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500114213

Enrollment

Unknown

Registered

2025-12-09

Start date

2026-01-01

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Atherosclerotic Heart Disease

Interventions

Control group:A single 1.5 mL (284 mg) subcutaneous injection of normal saline is given within 72 h before surgery

a second injection is administered 3 months later, followed by maintenance injections every 6 months.

Inclisiran group:A single 1.5 mL (284 mg) subcutaneous injection of inclisiran is given within 72 h before surgery

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Undergoing elective off-pump coronary artery bypass grafting (CABG) in our hospital, meeting the surgical indications for CABG (left main coronary artery stenosis >50%; left-main-equivalent disease, defined as proximal stenosis >75% in both the LAD and LCX; three-vessel disease with stenosis >75%; coronary artery disease combined with left ventricular dysfunction; failed PCI or in-stent restenosis). 2.Age 40–80 years. 3.Good patient and family compliance, full understanding of the study protocol, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing surgery for reasons other than standard CABG indications. 2. Conversion from off-pump to on-pump CABG. 3. Planned concomitant valve surgery for valvular disease. 4. Emergency CABG for acute myocardial infarction. 5. History of arrhythmias requiring chronic anti-arrhythmic therapy. 6. Prior COPD, asthma, or other chronic lung disease; autoimmune disorders (e.g., SLE, Sjögren’s syndrome); or active malignancy. 7. Previous stroke documented by pre-operative CT/MRI and consultant report. 8. Pregnant, lactating, or planning pregnancy. 9. Dementia, cognitive impairment, or inability to understand or comply with study instructions. 10. Alcohol or drug abuse. 11. Known hypersensitivity to study drugs. 12. Inclisiran or any PCSK9 inhibitor within 12 weeks before enrollment. 13. Participation in another clinical trial within 6 months. 14. Any other condition that, in the investigator’s opinion, renders the patient unsuitable for participation.

Design outcomes

Primary

Measure	Time frame
The incidence of adverse cardiovascular and cerebrovascular events within three months;3-month graft patency rate;	—

Secondary

Measure	Time frame
Incidence of other postoperative adverse events;	—

Countries

China

Contacts

Public ContactLuyao Ma

Jiangsu Provincial People's Hospital

penglu@njmu.edu.cn+86 189 3689 4021

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026