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Starting soon Not applicable

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

NCT06730802 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2024-12-12

Condition(s) studied

Myocardial Ischaemic SyndromeCoronary Heart Disease

Investigational drug(s) / intervention(s)

PCSK9 inhibitor →Statin

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

Statin: the control group will receive standard statin therapy.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (2)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality
The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06730802 on ClinicalTrials.gov ↗ ← All trials in China