Coronary Heart Diseases
Conditions
Interventions
case series:evolumab
Sponsors
the Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old; 2. Diagnose coronary atherosclerotic heart disease by coronary angiography; 3. Have received statin for stable blood lipids, meet the inclusion criteria, and do not change the lipid-lowering regimen during the trial; 4. Subjects who have not received lipid-lowering therapy are given statin therapy according to the treatment guidelines, and their blood lipids meet the inclusion criteria; 5. Those who cannot tolerate statin therapy should meet the statin intolerance criteria (see Annex 1 for specific criteria); 6. The subject's LDL-c level meets the following criteria: (1) LDL-C >=1.8 mmol/L in the latest fasting test result before enrollment (within 1 month); (2) Before enrollment ((within 1 month)), the result of the latest fasting examination was TG<=4.5mmol/L.
Exclusion criteria
Exclusion criteria: 1. Allergy to iodine contrast agent; 2. Allergic to any component of iloyoumab; 3. Intolerance to standardization and statin therapy; 4. Thyroid-stimulating hormone (TSH) 1.5 times upper limit of normal; 5. Pregnant and lactating patients; women of childbearing age who do not agree to contraception during the trial; 6. Severe liver damage (child-pugh grade C); 7. Cardiac function class III or IV (NYHA classification) or left ventricular ejection fraction =180mmHg; 10. Personal or family history of inherited muscle disorders; 11. Fasting triglyceride (TG) level at screening > 400 mg/dL (4.5 mmol/L); 12. Type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c>9%); 13. Glomerular filtration rate (eGFR) 3x the upper limit of normal at the time of screening or at the end of the stable blood lipid period; 15. Creatine kinase (CK) >3 times the upper limit of normal value at the time of screening or at the end of the stable blood lipid period; 16. Use of cholesteryl ester transfer protein (CETP) inhibitor 12 months before screening; 17. Those who have previously used ilovolumab or other PCSK9 inhibitors; 18. Subjects applied systemic cyclosporine, systemic steroids (such as iv, im or po) for more than 2 consecutive weeks in the inner layer 3 months before screening) (Note: hormone replacement therapy is allowed); treatment of skin Sick systemic vitamin A and retinol derivatives (Note: vitamin A in topical and multivitamin preparations is permitted); 19. History of malignant tumor (except non-melanoma skin cancer, cervical carcinoma in situ, breast ductal carcinoma in situ or stage 1 prostate cancer); 20. Known active infection, or severe hematological, renal, metabolic, gastrointestinal or endocrine dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume of epicardial adipose tissue; | — |
Secondary
| Measure | Time frame |
|---|---|
| Thickness of epicardial adipose tissue; | — |
Countries
China
Contacts
Public ContactZhao Cong
the Affiliated Hospital of Qingdao University
Outcome results
None listed