Acute coronary syndrome
Conditions
Interventions
experimental group:Intensive Lipid-Lowering Therapy(PCSK9 Monoclonal Antibodies+statins ±ezetimibe)
control group:Conventional Lipid-Lowering Therapy(statins ±ezetimibe)
Sponsors
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age of patient is between 18 and 75 years old, regardless of sex; 2. Patients with clinical diagnosis of non-ST segment elevation acute myocardial infarction (NSTE-AMI) and receiving PCI treatment, the baseline LDL-C of those patients should be between 1.4-3.4mmol/L. Angiographic Inclusion Criteria: 1. The patient has 2 or less primary in situ lesions planned for interventional surgery, including: one lesion in one vessel or one lesion in each of two vessels or two lesions in one vessel ; 2. Lesion diameter stenosis >= 50% and <100%; 3. The reference lumen diameter (RVD) must be between 2.5-4.0 mm; 4. The visual length of the target lesion is <= 35 mm. Inclusion criteria for PCI: 1. The type of stent specified by the implantation study.
Exclusion criteria
Exclusion criteria: 1. Patients with severe heart failure (Killip class III or IV) or with cardiogenic shock, LVEF 5 mg/dL, or ongoing dialysis) or with creatine kinase elevation 5 times more than the upper limit of normal; 4. patients with malignant tumors; 5. Patients with intolerance to statins or ezetimibe; 6. Patients with intolerance to injections; 7. The patients with other diseases (such as cancer, neurodeficient stroke) or a history of drug abuse (alcohol, etc.); Patients who, in the judgment of the physician, may not adhere to the protocol, affect the interpretation of the relevant data or have a limited lifespan (less than 1 year); 8. patients with poor compliance; 9. Patients with indications for anticoagulation; 10. People with allergies or contraindications to aspirin, heparin, bivalirudin, antiplatelet drugs (clopidogrel, and ticlopidine), rapamycin, lactic acid polymers, contrast agents, or stainless steel; 11. Pregnant or breastfeeding women, or women of gestational age but not using contraceptive measures. Optical coherence tomography (OCT) exclusion criteria: 1. The target vessels are severely distorted, calcified, and angled , according to the investigator's judgment, the placement of OCT catheter will cause risks or complications; 2. The target vessel has chronic total occlusion or its TIMI blood flow is grade 0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent endothelial coverage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fibrotic cap thickness in non-interventional coronary lesions;Lipid arc length in non-interventional coronary lesions; | — |
Countries
China
Contacts
Public ContactZhou Zhou
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed