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Effects of Preoperative PCSK9 Inhibitor Therapy on Epicardial Adipose Tissue and Coronary Atherosclerotic Plaque Progression in Patients Undergoing CABG

Effects of Preoperative PCSK9 Inhibitor Therapy on Epicardial Adipose Tissue and Coronary Atherosclerotic Plaque Progression in Patients Undergoing CABG

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109222
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-09-22

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

Intensive Group:Tolelsimab 150mg QOW + Rosuvastatin 10mg QN ± Ezetimibe 10mg QD
Control Group:Rosuvastatin 10mg QN ± Ezetimibe 10mg QD

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.18 years 2.8 mmol/L for statin-naïve patients, or LDL-C > 1.8 mmol/L for patients already on statin therapy; 5.Ability to comply with 6-month follow-up.

Exclusion criteria

Exclusion criteria: 1.Patients requiring emergency CABG surgery where baseline imaging data cannot be obtained. 2.Hemodynamic instability or uncontrolled malignant arrhythmia. 3.Complicated by cardiogenic shock or mechanical complications of the heart. 4.Treatment with any PCSK9 inhibitor within the past 3 months. 5.Severe renal insufficiency (creatinine clearance <30 mL/min), active liver disease or hepatic insufficiency, hematological diseases, metabolic or endocrine dysfunction, systemic infection, active malignant tumors, or any other life-threatening condition, or an expected survival of <1 year. 6.Concurrent acute or chronic pericardial disease. 7.Pregnant or breastfeeding women, or women planning pregnancy. 8.Patients deemed ineligible for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
EAT volume and density;Coronary atherosclerotic plaque volume;

Secondary

MeasureTime frame
Graft patency rate;Blood lipids;Serum adipokines;Inflammatory cytokines;

Countries

China

Contacts

Public ContactChen tienan

The Second Hospital of Tianjin Medical University

chentn1972@live.cn+86 137 5204 9209

Outcome results

None listed

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