Intermediate risk atherosclerotic cardiovascular disease population
Conditions
Interventions
Treatment Group (Xuezhikang Capsules Group):Xuezhikang Capsules treatment
Control Group (Placebo Group):Placebo treatment
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years old (including 18 and 80), applicable to both men and women; 2. According to the "Chinese Guidelines for Dyslipidemia Management (2023)", participants assessed as having a medium risk of 10-year ASCVD, specifically meeting any of the following conditions: (1) Participants without hypertension (diagnostic criteria detailed in Appendix 1.3 of the study protocol) and having 2 risk factors (including smoking, low HDL-C, and men >=45 years old or women >=55 years old, with risk factor levels at pre-intervention baseline), with LDL-C between 3.4 mmol/L and <4.9 mmol/L or TC between 5.2 mmol/L and <7.2 mmol/L; (2) Participants without hypertension but having 3 risk factors, with LDL-C between 2.6 mmol/L and <4.9 mmol/L or TC between 4.1 mmol/L and <7.2 mmol/L; (3) Participants with hypertension and 1 risk factor, with LDL-C between 2.6 mmol/L and <4.9 mmol/L or TC between 4.1 mmol/L and <7.2 mmol/L; (4) Participants with hypertension and 2 risk factors, with LDL-C between 1.8 mmol/L and <2.6 mmol/L or TC between 3.1 mmol/L and <4.1 mmol/L; 3. Women of childbearing potential (who have not undergone surgical sterilization and/or are less than 1 year post-menopause) must have a negative urine pregnancy test during the screening period. Male participants and female participants of childbearing potential, as well as their spouses/partners, should have no pregnancy plans (including sperm or egg donation) during the study period and voluntarily use effective contraception; 4. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Diabetes patients at high risk of ASCVD refer to diabetes patients aged >=40 years, diabetes patients aged 20–39 years with >=3 risk factors or with target organ damage, or type 1 diabetes with a disease duration of >=20 years (main risk factors include hypertension, dyslipidemia, smoking, obesity, and a family history of early coronary heart disease; target organ damage includes proteinuria, impaired kidney function, left ventricular hypertrophy, or retinopathy); 2. Patients with chronic kidney disease stages 3–5; 3. Patients with a history of atherosclerotic cardiovascular disease, such as coronary heart disease, coronary or other vascular revascularization, atherosclerotic stroke or transient ischemic attack (TIA), or atherosclerotic peripheral artery disease; diagnostic criteria for coronary heart disease, stroke, and TIA are detailed in Appendix 1.4–1.6 of the study protocol; 4. Participants who experienced cerebrovascular accidents, severe trauma, or underwent major surgery within 6 months prior to the screening period; 5. Hereditary lipid disorders, such as familial hypercholesterolemia (FH); diagnostic criteria for FH are detailed in Appendix 1.7 of the study protocol; 6. Coexisting diseases that may lead to lipid abnormalities, such as nephrotic syndrome, hypothyroidism, gout, acute or chronic hepatobiliary disease, systemic lupus erythematosus, glycogen storage disease, multiple myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome, etc; 7. Dyslipidemia caused by medications (such as glucocorticoids, estrogen, retinoids, cyclosporine, antidepressants, vascular endothelial growth factor inhibitors, aromatase inhibitors, diuretics, etc.); 8. Participants with a history of using nucleic acid-based lipid-lowering drugs, such as ApoA antisense oligonucleotides or ApoA small interfering RNA (siRNA); 9. Participants who used the following drugs that significantly affect lipid metabolism within 4 weeks prior to the screening period: including statins, cholesterol absorption inhibitors, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, probucol, bile acid sequestrants, and other major cholesterol-lowering lipid-regulating drugs (such as fibrates, ezetimibe, etc.), fibrates, niacin, high-purity fish oil preparations, microsomal triglyceride transfer protein inhibitors, apolipoprotein B100 synthesis inhibitors, angiopoietin-like protein 3 inhibitors, ApoC3 inhibitors, traditional Chinese medicine and proprietary Chinese medicines with lipid-lowering effects, etc.; 10. Individuals with non-cardiovascular diseases with an expected life expectancy of less than 2 years; 11. Individuals with a history of myositis, myopathy, or rhabdomyolysis, or with severe muscle abnormalities and neuropathy; 12. Any condition that may significantly affect drug absorption, distribution, metabolism, and excretion, such as a history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or difficulty urinating, acute gastroenteritis, digestive tract ulcer, history of gastrointestinal bleeding, etc.; 13. Participants with any of the following abnormal indicators during the screening period: (1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN); (2) Serum creatine kinase (CK) > 2.5 × ULN; 14. Individuals allergic to the investigational drug; 15. Breastfeeding women; 16. Participants who are currently enrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change in LDL-C from baseline to 24 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage change in LDL-C from baseline to 1 month, 3 months, 6 months, 12 months, 18 months;Drug-induced liver injury;The percentage change in TC, TG, HDL-C, ApoA1, ApoB, Lp(a) from baseline to 1 month, 3 months, 6 months, 12 months, 18 months, 24 months;The percentage change in CIMT, PWV, ABI from baseline to 12 months, 24 months;Cardio-cerebrovascular events at 24 months;All-cause mortality at 24 months;The percentage change in FMD from baseline to 12 months, 24 months;Drug-related muscular complications; | — |
Countries
China
Contacts
Public ContactBo Yu
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed