acute coronary syndrome
Conditions
Interventions
control group:standard treatment
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following 4 criteria are simultaneously met: 1. Male or female >= 18 years of age. 2. Acute coronary syndrome conforms to one of the following diagnoses: A. Acute st-segment elevation myocardial infarction: simultaneously meeting the following four criteria: 1) typical ischemic chest pain and other clinical manifestations; 2) ST segment elevation was in the dorsal-arch upward pattern, which appeared on the lead of the myocardial injury area around the necrotic area;The wide and deep Q wave (pathological Q wave) appeared on the lead in the area of transmural myocardial necrosis. T - wave inversion occurs on the lead in the myocardial ischemia area around the injury area. In the dorsal infarct area, the lead changes were reversed, that is, the R wave increased, the ST segment decreased, and the T wave stood up and increased. 3) elevated levels of cardiac marker cTnT/cTnI or ck-mb. 4) revascularization confirmed by coronary angiography or without revascularization. 5) within 24 hours of onset. B. Unstable angina pectoris: it also meets the following four criteria: 1) typical ischemic chest pain and other clinical manifestations; 2) typical ischemic ecg changes (new or transient ST segment shift >= 0.1mV, or T wave inversion >= 0.2mV); 3) cardiac marker cTnT/cTnI or ck-mb levels did not exceed the normal range. 4) revascularization confirmed by coronary angiography or without revascularization; 5) within 72 hours of onset. C. Acute non-st-segment elevation myocardial infarction: simultaneously meeting the following four criteria: 1) typical ischemic chest pain and other clinical manifestations; 2) ischemic ecg changes (new or transient ST segment shift >= 0.1mV, or T wave inversion >= 0.2mV); 3) elevated levels of cardiac marker cTnT/cTnI or ck-mb. 4) revascularization confirmed by coronary angiography or without revascularization. 5) within 72 hours of onset. 3. LDL-C levels at screening: (1) LDL-C >= 70 mg/dL (>=1.8 mmol/L) or non-HDL-C >= 100 mg/dL ( >= 2.6 mmol/) in patients who have been receiving stable treatment with high-intensity statin within >= 4 weeks prior to enrolment (ie, continuous treatment that has not changed with regard to statin intensity over the past 4 weeks) or (2) LDL-C >= 90 mg/dL (>= 2.3 mmol/L) or non-HDL-C >= 120 mg/dL ( >= 3.1 mmol/) in patients who have been receiving stable treatment with low- or moderate-intensity statin within >= 4 weeks prior to enrolment (ie, continuous treatment that has not changed with regard to statin intensity over the past 4 weeks) or (3) LDL-C >= 125 mg/dL (>= 3.2 mmol/L) or non-HDL-C >= 155 mg/dL ( >= 4.0 mmol/) in patients who are statin-nave or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrolment. 4. Patients or legal representatives are willing and able to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Unstable clinical status (hemodynamic or electrical instability). 2. Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response not controlled by medications in the past 3 months prior to screening. 3. Severe renal dysfunction, defined by estimated glomerular filtration rate 3 x the upper limit of normal. 5. Known allergy to contrast medium, heparin, aspirin, ticagrelor, or prasugrel. 6. Reported intolerance to atorvastatin (any dose) or statin intolerance. 7. Patients who previously received evolocumab or another PCSK9 inhibitor. 8. Patient who received cholesterol ester transfer protein inhibitors within 12 months prior to screening. 9. Treatment with systemic steroids or systemic cyclosporine in the past 3 months (eg, intravenous, intramuscular, or per os). 10. Known active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator. 11. Current enrolment in another investigational device or drug study. 12. Active malignancy requiring treatment. 13. Pregnancy. 14. Inability or unwillingness to complete follow-up. 15. Other conditions considered inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major cardiovascular events at 1 year;the proportion of LDL-C < 1.8 or more than 50% lower than baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Security Index; | — |
Countries
China
Contacts
Public ContactZhang Yuling
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed