atherosclerotic cardiovascular disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age >= 18; 3. LDL-C >= 70 mg/dl; 4. Meet the diagnostic criteria for atherosclerotic cardiovascular disease (clinical manifestations or imaging evidence); 5. 18.5 <= BMI <= 40 kg/m^2.
Exclusion criteria
Exclusion criteria: 1.Those who had ketoacidosis or hyperosmolar state within the previous 6 months and required hospitalization for treatment, or whose HbA1c was >= 8% before the screening; 2.Those who had experienced myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, peripheral artery disease, or transient ischemic attack within the previous 3 months; 3.Those with left ventricular ejection fraction < 30%; 4.Those with severe hematological diseases; 5.Those with severe renal dysfunction; 6.Those with severe diseases and an expected lifespan of less than 1 year; 7.Those who participated in other drug clinical trials in the past 1 year; 8.As determined by the investigator, those who are not suitable to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in LDL-C levels from baseline at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical endpoints (cardiovascular mortality, myocardial infarction, revascularization, rehospitalization rate, stroke, and other MACE incidence);Alternative endpoints (changes in electrocardiogram, changes in UCG indicators, 6-minute walk distance, quality of life scores, changes in physical indicators, changes in laboratory indicators, adherence to guideline-recommended medications);Health-related quality of life (assessed using the SF-36 Health Survey); | — |
Countries
China
Contacts
Nanfang Hospital, Southern Medical University