Carotid atherosclerotic plaque
Conditions
Interventions
Danxiong Granules group:Danxiong Granule formula in combination with standard background therapy, consisting of atorvastatin calcium tablets (20 mg per tablet), administered orally at a dose of 1 tabl
placebo group:Danxiong Granule placebo in combination with standard background therapy, consisting of atorvastatin calcium tablets (20 mg per tablet), administered orally at a dose of 1 tablet once da
Sponsors
The First Affiliated Hospital Of University Of South China
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age =50 years and =75 years; both males and females are eligible. 2.Carotid ultrasonography demonstrates atherosclerotic plaque with a Plaque-RADS score =3a. 3.Traditional Chinese medicine (TCM) syndrome differentiation meets the diagnostic criteria for blood stasis syndrome. 4.Voluntarily provides written informed consent.
Exclusion criteria
Exclusion criteria: 1.Carotid ultrasonography shows atherosclerotic plaque causing carotid luminal stenosis =70% (measured by the North American Symptomatic Carotid Endarterectomy Trial [NASCET] method). 2.History of intracerebral hemorrhage within the past 3 months, or other bleeding tendencies. 3.Concomitant severe systemic diseases such as significant hepatic or renal dysfunction (transaminases >1.5× the upper limit of normal [ULN]; serum creatinine >1.5× ULN). 4.Malignant neoplastic disease with an expected survival <1 year. 5.Severe psychiatric disorders or severe cognitive impairment that precludes treatment adherence or may affect treatment response. 6.Known allergy to any component of the investigational product or an allergic constitution. 7.Pregnant or lactating women, or women of childbearing potential with plans for pregnancy. 8.Unable to correctly operate a smartphone, even with assistance from family members. 9.Participation in another clinical study within the past month. 10.Any other condition deemed by the investigator to make the participant unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in carotid intima-media thickness (CIMT) at Weeks 52; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular and cerebrovascular events (MACCE): Including new or recurrent ischemic stroke, TIA, cerebral hemorrhage, ACS, coronary revascularization, and cardiovascular or cerebrovascular death;Mean CIMT at 26 weeks of treatment;Change in Plaque-RADS category;Maximum Wall Thickness;Change in lipid-rich necrotic core (LRNC) volume;Therapeutic Efficacy Scoring for CAPs With Blood Stasis Syndrome as the Core Syndromic Element; | — |
Countries
China
Contacts
Public ContactTang Hui-fang
The First Affiliated Hospital Of University Of South China
Outcome results
None listed