Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome After Percutaneous Coronary Intervention
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Metabolomics analysis of patients' platelets collected before and after treatment
研究概览
简要总结
To evaluate the platelet function, clinical efficacy, prognosis and safety of Xuesaitong soft capsule in the treatment of acute coronary syndrome, 50 patients with acute coronary syndrome after PCI were treated with Xuesaitong soft capsule (mainly Panax notoginseng saponins) for 4 weeks. The macroscopic and microscopic characterization and biological basis of Xuesaitong soft capsule in the treatment of acute coronary syndrome were explained by multi-group techniques (platelet transcription group, metabolic group, protein group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) it accords with the diagnostic criteria of western medicine for acute coronary syndrome.
- •(2) within 4 weeks after coronary intervention.
- •(3) 18 years old ≤ age ≤ 80 years old, male or female.
- •(4) voluntarily participate in this clinical trial, give informed consent and sign an informed consent form
排除标准
- •(1) uncontrollable hypertension after drug treatment (systolic blood pressure > 180mmHg, or diastolic blood pressure > 110mmHg).
- •(2) increased risk of bleeding: previous history of hemorrhagic stroke; intracranial aneurysms; trauma or major surgery within 1 month (including bypass surgery); diseases currently suffering from active bleeding, etc.
- •(3) patients with history of digestive tract ulcer and massive gastrointestinal bleeding.
- •(4) severe organic heart disease, such as patients with LVEF < 35% or NYHA/Killip cardiac function grade IV.
- •(5) those with a history of malignant arrhythmias (arrhythmias affected by hemodynamics, requiring drug or electrical cardioversion, or cardiopulmonary resuscitation), congenital heart disease or malignant tumor were considered unable to participate in the trial.
- •(6) severe hepatic and renal insufficiency: glutamic pyruvic transaminase (ALT) or aspartate oxaloacetic transaminase (AST) ≥ 3 × normal upper limit (ULN) or total bilirubin (TBIL) ≥ 2 × ULN; or creatinine clearance (Ccr < 30ml/min).
- •(7) Women in pregnancy (defined as positive blood pregnancy test) and lactating women.
- •(8) those with a history of blood donation or significant blood loss in the last 3 months (≥ 400ml).
- •(9) people with a previous history of alcoholism (i.e. men drink more than 28 standard units per week and women drink more than 21 standard units per week (1 standard unit contains 14g alcohol, such as 360mL beer or 25mL spirits or 150mL wine with 40% alcohol content); or screen those who drink regularly in the first 6 months (that is, more than 14 standard units per week).
- •(10) those with a history of drug abuse and drug dependence within one year before screening.
- •(11) those who have participated in other clinical trials and taken trial drugs in the past 3 months.
- •(12) people who are allergic or intolerant to aspirin or P2Y12 receptor inhibitors.
- •(13) those who are allergic to the ingredients of the test drugs.
- •(14) other situations in which the researchers think it is not appropriate to participate in this experiment.
研究组 & 干预措施
Intervention group
Routine western medicine treatment (oral drug therapy and standard percutaneous coronary intervention) + Xuesaitong soft capsule, 0.33g/ tablets, 2 tablets each time, twice a day. The treatment period is 4 weeks
干预措施: Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins) (Drug)
结局指标
主要结局
Metabolomics analysis of patients' platelets collected before and after treatment
时间窗: 4 weeks
This measure involves the collection of patients' platelets for comprehensive metabolomics analysis. This analysis aims to identify changes in metabolic pathways and metabolites before and after treatment. Data will be summarized based on identified metabolites and altered metabolic pathways, which will help elucidate the treatment's effects on platelet function at the metabolic level.
Proteomics analysis of patients' platelets collected before and after treatment
时间窗: 4 weeks
This measure involves the collection of patients' platelets for comprehensive proteomics analysis. This analysis aims to identify changes in protein expression patterns before and after treatment. Data will be summarized based on differentially expressed proteins, providing insights into the treatment's impact on platelet function at the proteomic level.
Transcriptome analysis of patients' platelets collected before and after treatment
时间窗: 4 weeks
This measure involves the collection of patients' platelets for comprehensive transcriptome analysis. This analysis aims to identify changes in gene expression profiles before and after treatment. Data will be summarized based on differentially expressed genes, providing insights into the impact of treatment on platelet function at the transcriptional level.
次要结局
- Changes in platelet granule markers, including platelet factor 4 (PF4) and β-thromboglobulin, before and after treatment, as assessed by ELISA(4 weeks)
- Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry(4 weeks)
- white blood cell count and red blood cell count(4 weeks)
- hemoglobin levels(4 weeks)
- hematocrit levels(4 weeks)
- platelet count(4 weeks)
- Urine analysis of biochemical markers(4 weeks)
- Urine analysis of cellular components(4 weeks)
- Stool appearance(4 weeks)
- Biochemical components in stool(4 weeks)
- Cellular components in stool(4 weeks)
- liver function based on the enzyme levels(4 weeks)
- liver function based on the bilirubin levels(4 weeks)
- Serum creatinine and blood urea nitrogen (BUN)(4 weeks)
- Estimated glomerular filtration rate (GFR)(4 weeks)
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT)(4 weeks)
- International normalized ratio (INR)(4 weeks)
- Assessment of electrocardiogram (ECG) parameters, including QT interval, heart rate, and ST segment changes, before and after treatment(4 weeks)