atherosclerosis
Conditions
Interventions
Placebo group:Placebo capsule with the same appearance of Tongxinluo capsule, made by Yiling Pharmaceutical Co., China, will be given orally after meals, 6 capsules each time, twice daily.
Treatment group:Tongxinluo capsule, made by Yiling Pharmaceutical Co., China, will be given orally after meals, 6 capsules each time, twice daily.
Sponsors
Shandong University Qilu Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 40 to 75 years; 2. Existence of non-calcified plaque detected by ultrasonography (defined as defined as a focal thickening of the carotid IMT of 1.2 to 3.5 mm in bilateral common or internal carotid arteries); 3. Consent obtainable from patient or proxy.
Exclusion criteria
Exclusion criteria: 1. Patients aged 75 years; 2. With history of percutaneous coronary intervention or carotid endarterectomy; 3. With history of myocardial infarction or stroke within the past 6 months; 4. Uncontrolled diabetes mellitus (fasting glucose > 126mg/dl) or hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg); 5. Familial hypercholesterolemia; 6. Takayasu arteritis; 7. Pregnant or breast-feeding or planning to become pregnant within 1 year, or women of child-bearing age not using effective contraception; 8. Dysfunction of liver (relative index elevation three times the upper limit of normal values in our laboratory) and kidney (serum creatinine level > 2 mg/dl); 9. Presence of other clinical conditions such as respiratory disease, digestive disease, hematological disease, infection, immunological disease, endocrine disease, neuropathy, psychotic disorders, neoplasm, or a condition likely to harm subjects; 10. Requiring warfarin for anticoagulation therapy; 11.Receiving any other investigational traditional Chinese medication within 12 months before baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| between-group difference in change in mean IMT measured at 12 sites of the anterior and posterior walls of the bilateral common and internal carotid arteries; | — |
Secondary
| Measure | Time frame |
|---|---|
| between-group difference in change in maximal plaque area of the bilateral common and internal carotid arteries;between-group difference in change in vascular remodeling index of bilateral common carotid arteries;between-group difference in change and change rate in the serum levels of low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol and triglycerides;between-group difference in change and change rate in the serum levels of hs-CRP;between-group difference in major cardiovascular events (unstable angina pectoris, nonfatal myocardial infarction, cardiac death, coronary revascularization, stroke and death); | — |
Countries
China
Contacts
Public ContactYun Zhang
Shandong University Qilu Hospital
Outcome results
None listed