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

Launched by NANJING MEDICAL UNIVERSITY · Dec 9, 2024

Keywords

ClinConnect Summary

The PANDA VIII clinical trial is exploring whether a medication called a PCSK9 inhibitor can help protect patients after they undergo coronary artery bypass grafting (CABG), a surgery to improve blood flow to the heart. The study will involve adults aged 18 and older who have a condition known as myocardial ischemic syndrome, which is related to heart problems. Participants will be randomly assigned to either receive the PCSK9 inhibitor before their surgery, along with two additional doses in the following months, or to continue with standard care. After six months, the researchers will check inflammation levels and heart function to see if the medication had a positive effect.

To be eligible for this trial, participants must be preparing for CABG and willing to provide informed consent. However, certain individuals, such as pregnant women or those with severe allergies to the study drug, will not be included. This trial is not yet recruiting participants, so it’s an opportunity for those who meet the criteria to potentially contribute to new heart treatment options while receiving close medical attention during their recovery.

Gender

ALL

Eligibility criteria

• 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