Myocardial Ischaemic Syndrome, Coronary Heart Disease
Conditions
Keywords
inflammation, CABG
Brief 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.
Interventions
DRUGPCSK9 inhibitor
the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later.
DRUGStatin
the control group will receive standard statin therapy.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Beijing Anzhen Hospital
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein | 6 months after surgery | Peripheral blood C-reactive protein |
Countries
China
Contacts
Primary ContactHong Liu, MD
Backup ContactLu-yao Ma, MD
Outcome results
None listed