A multi-center, prospective, open-label, end-point blinding, randomized controlled clinical study of Maiguan Fukang tablets in patients with mild to moderate carotid stenosis
- Conditions
- mild to moderate carotid stenosis
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet with western medical diagnostic criteria for mild to moderate carotid artery stenosis (stenosis rate <50%, confirmed by cerebral angiography or CTA or MRA or non-invasive examination, refer to the guidelines for the diagnosis and treatment of carotid stenosis and the guidelines for vascular ultrasonography in stroke in China);
(2) Meet the diagnostic criteria of blood stasis syndrome in traditional Chinese medicine (refer to the Practical Diagnostic Criteria of Blood Stasis Syndrome by the Chinese Society of Integrative Medicine);
(3) Ultrasonography revealed that the carotid artery intima-media is thickened (IMT=1.2mm), and the carotid artery plaques are iso-echoic plaques or mixed-echo plaques;
(4) The 10-year cardiovascular disease risk is less than 5%;
(5) Adult patients are aged 18-70 (no gender limit, including 18-year-old and 70-year-old patients);
(6) Informed and signed informed consent form.
(1) Patients with intracranial hemorrhage, subarachnoid hemorrhage in the past 3 months, or fresh cerebral infarction or transient ischemic attack in the past 1 month;
(2) Cardiogenic embolism (atrial fibrillation, patent foramen ovale, left atrial appendage thrombosis, etc.);
(3) Carotid artery stent (CAS) or carotid artery stent (CEA) surgery is planned;
(4) The plaque is complete calcification, or the ultrasound examination indicates a hyperechoic plaque or an ulcer plaque;
(5) Patients with active bleeding or high risk of bleeding (such as those with peptic ulcer, bronchiectasis, and tuberculosis in the last 3 months);
(6) Patients with severe heart, brain, liver, kidney, hematopoietic system, connective tissue diseases, endocrine diseases and mental diseases (such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >1.5 times the upper limit of normal value and serum creatinine (SCR) > the upper limit of normal value; or patients with low density lipoprotein(LDL-C)=3.4mmol/L;
(7) Allergic to the test drug and its components, or allergic constitution;
(8) Those who have planned to perform surgery within the experimental period or within 10 days after the end of the experiment;
(9) Hypertensive patients with blood pressure >180/110mmHg that cannot be controlled through the best treatment plan;
(10) Patients with coronary heart disease: coronary artery stenosis = 75% confirmed by coronary angiography or coronary CT angiography, or after percutaneous coronary intervention (PCI), or old myocardial infarction;
(11) Pregnant, planned or lactating women;
(12) Those who have participated or are participating in other clinical research within 3 months;
(13) Those who judged by the investigator to be unsuitable to participate in this trial or are likely to be lost to follow-up.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean IMT of common carotid artery;
- Secondary Outcome Measures
Name Time Method Mean IMT of extracranial internal carotid artery;resistance index of carotid artery;End-diastolic flow rate of carotid artery;Carotid artery stenosis rate;Mean IMT of carotid bulb;peak systolic velocity of carotid artery;Carotid plaque area;Carotid plaque size;Blood lipids;Total score of bilateral carotid plaque ;TCM Syndrome Score of Blood Stasis Syndrome;Maximum IMT of common carotid artery;hs-CRP;Seattle Angina Questionnaire;Maximum IMT of carotid bulb;Maximum IMT of extracranial internal carotid artery;