ITMCTR2200005761尚未招募4 期
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
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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.
研究者
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