Patients diagnosed with ASCVD who still have fasting LDL-C = 1.8 mmol/L after receiving at least one month of treatment with atorvastatin 20 mg/day.The diagnostic criteria are as follows:a) A confirmed diagnosis of atherosclerosis-related diseases (such as myocardial infarction, ischemic stroke, coronary revascularization, etc.)
Conditions
Interventions
PCSK9 Monoclonal Antibody Intensified Group:On the basis of the standard clinical treatment (Atorvastatin (20 mg/day) + Hybutimibe (10 mg/day) for 3 consecutive months), a single subcutaneous in
Routine Stepwise Treatment Group:Atorvastatin (20 mg/day) + Hybutimibe (10 mg/day) for 3 consecutive months, which represents the standard clinical treatment approach.
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 80 years (inclusive). 2.Patients diagnosed with ASCVD, with the diagnostic criteria as follows: a) A confirmed diagnosis of atherosclerosis-related diseases (such as myocardial infarction, ischemic stroke, coronary revascularization, etc.); b) Imaging examinations (e.g., coronary CTA, carotid ultrasound, etc.) demonstrating a diameter stenosis of more than 50% in major blood vessels. 3.Fasting LDL-C remains >= 1.8 mmol/L after receiving at least one month of treatment with atorvastatin 20 mg/day. 4.Voluntary participation in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of allergy or intolerance to any components such as atorvastatin, hybutimibe, or PCSK9 inhibitors. 2.Patients assessed as ultra-high risk for ASCVD. 3.Patients currently using or having used PCSK9 inhibitors within the past 3 months. 4.History of dilated cardiomyopathy, peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, hereditary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, or viral myocarditis. 5.History of moderate or greater valvular heart disease. 6.Patients with severe liver disease (ALT exceeding 3 times the upper limit of normal) or severe kidney disease (eGFR < 30 mL/min/1.73m^2). 7.Rheumatic systemic diseases (currently using glucocorticoids or anti-rheumatic drugs). 8.Patients with malignant tumors or those with a life expectancy of less than one year. 9.History of drug or alcohol abuse within the past 12 months. 10.Vulnerable populations, including individuals with mental disorders, cognitive impairment, critically ill patients, pregnant or lactating women, or illiterate individuals. 11.Other conditions deemed by the investigator that make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of achieving the target plasma LDL-C level of <1.8 mmol/L at three months.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular events;The rate of achieving the LDL-C target at each monthly visit (months 1, 2, and 3) during the three-month period.;LDL-C variability over the three months;The mean absolute reduction and percentage reduction in LDL-C at three months.; | — |
Countries
China
Contacts
Public ContactWenbin Zhang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed