Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)

Not Applicable

Not yet recruiting

• Conditions: Myocardial Ischaemic Syndrome; Coronary Heart Disease
• Interventions: Drug: Statin; Drug: PCSK9 inhibitor

• Registration Number: NCT06730802
• Lead Sponsor: Nanjing Medical University

Brief Summary

This is a multi-center, randomized controlled study to investigate whether early offering PCSK9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (CABG). Subjects with myocardial ischaemic syndromes (MIS) will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy, while the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later. Six month after CABG, CRP will be used to evaluate inflammation, and echocardiography and coronary CTA will be used to evaluate cardiovascular function.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Study Start: 2025-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Male or female ≥ 18 years of age
• Patients with myocardial ischemic syndromes (with any of the following):
• Patients are ready to undergo coronary artery bypass grafting (CABG) with 1 month;
• Participate voluntarily and sign an informed consent

Exclusion Criteria

i. Pregnant and lactating women ii. During the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods iii. Have used PCSK9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to PCSK9 inhibitors iv. Severe infections requiring intravenous antibiotics v. HIV-positive or history of acquired immunodeficiency syndrome (AIDS) vi. With cognitive impairment or psychiatric illnesses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin	Statin	the control group will receive standard statin therapy.
PCSK9 inhibitor	PCSK9 inhibitor	the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular and Cerebrovascular Events	6 months after surgery	Major Adverse Cardiovascular and Cerebrovascular Events include cardiac death, reinfarction, emergency coronary revascularization and stroke

Secondary Outcome Measures

Name	Time	Method
C-reactive protein	6 months after surgery	Peripheral blood C-reactive protein

Trial Locations

Locations (2)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China