Elderly patients with ASCVD
Conditions
Interventions
Interventional group:Bempedoic acid 10mg/d + Rosuvastatin 10mg/d, for 12 weeks
Sponsors
Ansteel Group General Hospital
Eligibility
Sex/Gender
All
Age
75 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 75 years, gender not limited; 2. Meeting the diagnostic criteria for ASCVD, which are based on the Chinese Guidelines for Lipid Management (2023 Edition); covering all patients with ASCVD (coronary heart disease: history of myocardial infarction; or history of coronary revascularization [percutaneous coronary intervention or coronary artery bypass grafting]; significant coronary artery stenosis confirmed by coronary angiography [stenosis > 50% in one major epicardial artery], or significant atherosclerotic plaques confirmed by coronary computed tomography [multi-vessel coronary artery disease with stenosis > 50% in two major epicardial arteries]); 3. A history of statin therapy for more than 1 month, with LDL-C failing to reach the target values recommended by guidelines (LDL-C < 2.6 mmol/L for moderate-high risk patients; < 1.8 mmol/L for very high risk patients; < 1.4 mmol/L for ultra-high risk patients). 4. Able to understand the study content and voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Unstable clinical status of patients (referring to the clinical condition at the time of randomization; informed consent can be signed and enrollment can be conducted after the patient’s condition stabilizes) (1) Sustained systolic blood pressure 180 mm Hg or DBP > 110 mm Hg); 7. Active liver disease or persistent elevation of ALT or AST = 3 × ULN; 8. Unexplained creatine kinase (CK) elevation > 5 × ULN, or CK elevation caused by known muscular disorders; 9. Subjects who have received drugs with known significant interactions with statin therapy within 1 month prior to randomization (e.g., antifungal agents such as itraconazole and ketoconazole [administered orally or by injection], antibiotics such as erythromycin, clarithromycin and rifampicin, immunosuppressants such as cyclosporine, and antiviral protease inhibitors such as entecavir), or who may require such treatment during the study period. 10. A history of active malignant tumors (those who have undergone surgery, radiotherapy, and/or systemic therapy within the past 3 years); 11. Currently participating in another drug or device clinical trial, or having just completed another drug or device clinical trial, or having received other investigational drugs less than 30 days prior; 12. Any life-threatening comorbidities that are expected to result in death within the next 3 months (excluding cardiovascular diseases); 13. A history of alcoholism or substance abuse; and inability or unwillingness to abstain from alcohol and discontinue substance abuse during the study period. 14. A history of major organ transplantation (e.g., lung, liver, heart, bone marrow, kidney); 15. Any known, significant, active and uncontrolled diseases, or any medical, physical or surgical conditions (e.g., infection, major hematological, renal, metabolic, gastrointestinal or endocrine disorders) that are deemed by the investigator to potentially interfere with participation in this clinical trial. 16. In the investigator’s judgment, the subject has a low likelihood of subsequent follow-up or is not expected to complete follow-up exceeding 3 months (the subject may be unable to fulfill all protocol-required follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in LDL-C at Week 12;Safety Outcomes (including incidence of drug-related adverse events (AEs), CK elevation =5 times upper limit of normal, ALT/AST elevation =3 times upper limit of normal, new-onset diabetes, etc.);Incidence of Major Adverse Cardiovascular Events (MACE) and all-cause mortality; | — |
Countries
China
Contacts
Public ContactLuo Chao
Ansteel Group General Hospital
Outcome results
None listed