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)
Facility
City
Region
Status
Beijing Anzhen Hospital, Capital Medical University
Beijing
Beijing Municipality
The First Affiliated Hospital of Nanjing Medical University
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.
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