Carotid Atherosclerosis
Conditions
Interventions
Experimental group:Subjects were screened for examination after informed consent and those who passed the screening were given the product for 180 consecutive days and recorded in a diary card.Accordi
Sponsors
The First People's Hospital of Hefei
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 45–75 years; 2. Meeting Western medical diagnostic criteria for carotid atherosclerosis: Carotid intima-media thickening with irregularity, diagnosed when IMT > 1.0 mm or localized plaque is present; 3. Carotid atherosclerosis with < 50% stenosis and no surgical indication; 4. Willing to comply with treatment, observation, and all required examinations; 5. Fully informed and voluntarily consents to participate by signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of acute coronary syndrome or stroke; 2. Patients with malignant tumors; 3. Clinically significant arrhythmia; 4. Uncontrolled severe hypertension; 5. Poorly controlled type 2 diabetes mellitus at screening; 6. Diseases significantly affecting lipid levels (e.g., nephrotic syndrome, severe hepatic disease, severe hepatic/renal impairment); 7. Use of statin-contraindicated drugs/foods within <5 half-lives before screening (e.g., cyclosporine); 8. Chronic systemic use of cyclosporine or systemic corticosteroids within 1 month prior to screening or within 5 half-lives (whichever is longer); 9. Participation in other investigational drug/device trials within 30 days before screening or planned use during study; 10. History of drug abuse, substance addiction, or alcoholism; 11. Hypersensitivity to any study drug/excipients or pharmacologically similar compounds; 12. Pregnancy, lactation, or unwillingness to use effective contraception during the study and for 6 months post-dosing; 13. Any condition deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cIMT;Carotid maximum plaque length, width and thickness; | — |
Countries
China
Contacts
Public ContactWang Shu
The First People's Hospital of Hefei
Outcome results
None listed