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

Nanjing Medical University

Status: Not yet enrolling

Conditions: Coronary Heart Disease; Myocardial Ischaemic Syndrome

Treatments: Drug: PCSK9 inhibitor; Drug: Statin

Study type: Interventional

Funder types: Other

Identifiers

NCT06730802

PANDA VIII

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

PCSK9 inhibitor

Experimental group

Description:

the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later

Treatment:

Drug: PCSK9 inhibitor

Statin

Sham Comparator group

Description:

the control group will receive standard statin therapy.

Treatment:

Drug: Statin