Carotid atherosclerotic plaque
Conditions
Interventions
XZK Arm:Xuezhikang capsules plus atorvastatin calcium tablets (atorvastatin calcium tablets: 20 mg/tablet, 1 tablet once daily, taken at bedtime in the evening).
Placebo Arm:Xuezhikang capsule placebo plus atorvastatin calcium tablets (atorvastatin calcium tablets: 20 mg/tablet, 1 tablet once daily, taken at bedtime in the evening).
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 between 50 and 75 years, inclusive. Male or female. 2.Carotid ultrasonography demonstrating an atherosclerotic plaque with a Plaque-RADS score =3a. 3.Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Carotid ultrasound demonstrates atherosclerotic plaque causing carotid luminal stenosis =70%, as defined by the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. 2.Patients with a history of intracerebral hemorrhage within the past 3 months or with other bleeding tendencies. 3.Patients with concomitant severe systemic diseases such as significant hepatic or renal dysfunction (alanine aminotransferase or aspartate aminotransferase >1.5 times the upper limit of normal, or serum creatinine >1.5 times the upper limit of normal). 4.Patients with malignant disease and a life expectancy of less than 1 year. 5.Patients with severe psychiatric disorders or severe cognitive impairment who are unable to cooperate with treatment or whose treatment response may be affected. 6.Patients with known allergy to any component of the investigational drug or with an allergic constitution. 7.Pregnant women, lactating women, or women of childbearing age with fertility intentions. 8.Patients who are unable to use a smartphone correctly, even with assistance from family members. 9.Patients who have participated in other clinical studies within the past 1 month. 10.Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean CIMT from baseline after 1 year (52 weeks) of treatment.; | — |
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;Change in carotid intima-media thickness (CIMT) at Weeks 26;Change in Plaque-RADS category;Maximum wall thickness;Change in lipid-rich necrotic core (LRNC) volume; | — |
Countries
China
Contacts
Public ContactTang Hui-fang
The First Affiliated Hospital Of University Of South China
Outcome results
None listed