atherosclerosis
Conditions
Interventions
Control group:Statins for lipid-lowering therapy
Experimental group:Statins lipid-lowering therapy + HY-01 capsule
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 (inclusive) to 70 (inclusive) years, any gender; 2. Carotid ultrasound indicating carotid atherosclerotic plaques with 1.5 mm <= IMT <= 5 mm, soft or mixed plaques, non-hemorrhagic plaques. Plaques are distinct and easily observable; 3. According to the "Chinese Guidelines for Lipid Management (2023)", subjects have a history or evidence of primary hypercholesterolemia; and prior to screening, have undergone regular diet and at least 4 weeks of stable treatment with medium or higher intensity statins, with LDL-C <= 2.6 mmol/L; 4. Voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Carotid artery ultrasound examination shows that the plaques are all hard or calcified plaques; 2. Patients with new ischemic cardiovascular and cerebrovascular events or cerebral hemorrhage within one year in the past six months; 3. Patients with coagulation dysfunction, PT prolongation > upper limit of normal value 3 seconds or APTT prolongation > upper limit of normal value 10 seconds, or PLT450 ms in men, female QTcF >470 ms); 5. Patients with hypertension with systolic blood pressure >=160 mmHg or diastolic blood pressure >=110 mmHg, or those whose blood pressure control is not ideal after taking antihypertensive drugs; 6. Poor blood glucose control in diabetic patients, random blood glucose >=11.1 mmol/L; 7. Severe digestive system diseases or symptoms, including persistent diarrhea or inflammatory bowel disease; 8. Patients with severe mental illnesses who cannot cooperate with treatment or affect treatment response; 9. Women who are pregnant or planning to become pregnant; 10. Patients who may undergo surgery during the trial; 11. Those who are allergic to HY-01 or statins; 12. Previous carotid endarterectomy; 13. Those who have participated in any drug clinical trial and taken an investigational drug in the past 3 months, or who have participated in a clinical trial of an in vivo medical device and used a medical device; 14. Having any conditions that may increase the risk of adverse events or abnormal laboratory test results in the participant, as judged by the investigator; or have any serious or unstable physical or psychological conditions that may endanger the safety of patients or affect their participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change rate of carotid atherosclerotic plaque volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AE);Inflammatory factors, cardiovascular risk factors (such as blood glucose, blood lipids, uric acid, and blood pressure);Change rate of carotid atherosclerotic plaque volume;Changes in carotid plaque composition;Laboratory tests of clinical significance;Liver ultrasound and gut microbiota testing;12-lead electrocardiogram;Vital signs (blood pressure, pulse, body temperature);Physical examination; | — |
Countries
China
Contacts
Public ContactHuang Zhijun
The Third Xiangya Hospital Central South University
Outcome results
None listed