Coronary artery disease
Conditions
Interventions
Standard-care Group:It was performed according to the clinical routine
Ricarcicumab group:Ricarcicumab subcutaneous injection
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The age of onset is no more than 55 years old for men and no more than 65 years old for women. 2. Due to hospitalization for acute coronary syndrome, coronary angiography and OCT examinations are required, and there is a need for re-examination of angiography and OCT after 9 months. Whether PCI treatment is performed this time does not affect the inclusion. 3. The diameter stenosis rate of the target lesion is greater than or equal to 30% (estimated by visual inspection), and interventional treatment is not planned for this target lesion. The target lesion may be located in the coronary arteries treated with PCI and those not treated with PCI. If it is located in the PCI treatment vessel, the distance between the target lesion and the treatment lesion should be >=10 millimeters (visually estimated). 4. Among patients who received statin treatment =2 weeks before enrollment, LDL-C was >=1.8 mmol/L, or those who did not receive statin treatment had LDL-C>=3.0 mmol/L; 5.OCT examination shows that the target lesion is a lipid-rich plaque (lipid curvature >=90°) or a thin fibrous cap plaque (mFCT<=150µm). 6. Voluntarily participate in this study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with hemodynamic instability and severe arrhythmia; 2. Patients with a history of bleeding within 3 months or severe hemostasis and coagulation dysfunction; 3. Severe liver and renal dysfunction (ALT>=5 ULN, eGFR<=30ml/min/1.73m^2); 4. Patients with severe chronic obstructive pulmonary disease (COPD) or respiratory failure; 5. Severe infection; 6. Patients with malignant tumors; 7. Allergy or contraindication to aspirin, heparin, bivalirudin, antiplatelet drugs (clopidogrel, ticlopidine), rapamycin, lactic acid polymer, contrast media or stainless steel; 8. Patients who had taken a PCSK9 inhibitor in the previous 6 months; 9. Those who have participated in other clinical trials; 10.OCT exclusion criteria: a. The target vessel was severely distorted, calcified, or angulated, and the OCT catheter placement would cause risk or complications as judged by the investigator; b. presence of chronic total occlusion or TIMI flow grade 0 in the target vessel c. Other conditions not suitable for OCT examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum fibrous cap thickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum lipid arc;Lipid length;Lipid volume index;Macrophage accumulation (mean angular elongation of macrophages);Changes in calcification indicators; | — |
Countries
China
Contacts
Public ContactYingguang Shan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed