Carotid atherosclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign an informed consent form; 2.Age greater than 18 years at screening, regardless of gender; 3.Diagnosed with hypertension [Hypertension: defined as three measurements on different days of systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg, or currently using antihypertensive medications] with one or more risk factors [smoking, low high-density lipoprotein cholesterol (HDL-C), age >=45/55 years (male/female)]; 4.Carotid ultrasound showing low echogenic or heterogeneous plaques with less than 50% carotid stenosis [Arterial plaque is defined as a local intima-media thickness of 1.5 mm or more, protruding into the lumen, or at least 0.5 mm or 50% thicker compared to the surrounding intima-media thickness]; 5.Fasting serum LDL-C level < 3.0 mmol/L and fasting serum TG level < 5.6 mmol/L; 6.No statin use in the past month; 7.Not diagnosed with ASCVD.
Exclusion criteria
Exclusion criteria: 1. Individuals allergic to the ingredients of Xuezhikang; 2.Clear history of coronary heart disease (CAG or CTA indicating coronary artery stenosis =50%) or clinical manifestations requiring reperfusion therapy for ASCVD; 3. Active liver disease or abnormal liver function, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels exceeding 1.5 times the upper limit of the reference range; or significantly elevated creatinine (creatinine > 250 µmol/L); 4.Creatine kinase (CK) levels exceeding 1.5 times the upper limit of the normal reference range; 5.Concurrent use of medications affecting lipid metabolism, such as glucocorticoids, estrogens, retinoids, cyclosporine, antidepressants, vascular endothelial growth factor inhibitors, aromatase inhibitors, etc.; 6.Concurrent diseases affecting lipid metabolism, such as liver disease, nephrotic syndrome, hypothyroidism, systemic lupus erythematosus, glycogen storage disease, multiple myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome, etc.; 7.Pregnant or breastfeeding women; 8.Individuals currently participating in other clinical trials; 9.Individuals with unstable clinical status, severe heart or lung failure, uncontrolled arrhythmias, cancer history, life expectancy less than 1 year, or those judged by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C reduction;Assessment of carotid plaques; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemical markers;Other lipid parameters;Inflammatory factors and biomarkers;Plaque stability and endothelial function-related mediators; | — |
Countries
China
Contacts
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine