Hypercholesterolemia
Conditions
Interventions
the evolocumab group:The evolocumab group received evolocumab (140 mg/injection
administered subcutaneously once every two weeks
Amgen Biopharmaceutical Company, USA) in addition to conventional lipid-lowering therapy (high-intensity or maximum tolerable dose of rosuvastatin
with or without ezetimibe, as determined by the clinician).
the control group:The control group received only conventional lipid-lowering therapy (high-intensity or maximum tolerable dose of rosuvastatin, with or without ezetimibe).
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with ALK-positive advanced non-small cell lung cancer who developed hypercholesterolemia after lorlatinib targeted therapy. Among them, hyperlipidemia is defined as having low-density lipoprotein (LDL-C) levels within the normal range before targeted therapy, and lipid tests conducted one month after targeted therapy showing elevated LDL-C levels greater than 190 mg/dL or 4.9 mmol/L.
Exclusion criteria
Exclusion criteria: 1. Previous occurrence of atherosclerotic cardiovascular disease (ASCVD) events; 2. Already on lipid-lowering therapy including statins; 3. Planned coronary revascularization within 3 months after randomization; 4. Baseline liver dysfunction (elevated alanine aminotransferase greater than 3 times the upper limit of normal); 5. Baseline renal dysfunction (eGFR less than 30 mL/min/1.73m^2); 6. Baseline myogenic injury (elevated creatine kinase greater than 5 times the upper limit of normal); 7. Pregnant, breastfeeding, or planning pregnancy; 8. Already enrolled in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in LDL-C after lipid-lowering therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute value of LDL-C after lipid-lowering therapy;According to the "2019 ESC/EAS Guidelines for the Management of Dyslipidaemias," the proportion of high-risk/very high-risk patients achieving target LDL-C reduction in primary prevention;Cardiovascular adverse events (defined as composite endpoint events including cardiac death, acute myocardial infarction, stroke, or coronary revascularization due to hospitalization for unstable angina); | — |
Countries
China
Contacts
Public ContactZhang Weifeng
Shanghai Chest Hospital
Outcome results
None listed