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NCT Number: NCT06730802

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

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.

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Key information

Conditions

Myocardial Ischaemic Syndrome Cardiovascular Diseases Coronary Disease Coronary Heart Disease Heart Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCSK9 inhibitor

Drug

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

Statin

Drug

the control group will receive standard statin therapy.

Primary outcomes

  1. Major Adverse Cardiovascular and Cerebrovascular Events

    Time frame: 6 months after surgery

    Major Adverse Cardiovascular and Cerebrovascular Events include cardiac death, reinfarction, emergency coronary revascularization and stroke

Secondary outcomes

  1. C-reactive protein

    Time frame: 6 months after surgery

    Peripheral blood C-reactive protein

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Liu, MD

CONTACT

[email protected]

18801281613

Lu-yao Ma, MD

CONTACT

[email protected]

02568303101

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • Beijing Anzhen Hospital
  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Acronym: PANDA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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