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
- 3 期
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Changes in thromboelastography induced by AA, including R value, K value , α angle , MA value , CI, TPI， LY30, and AAYZL, before and after treatment, as assessed by thromboelastography.
研究概览
简要总结
To assess the effects of Xuesaitong soft capsules on platelet function, clinical efficacy, prognosis, and safety in the treatment of acute coronary syndrome, 400 patients with acute coronary syndrome who underwent PCI were treated with Xuesaitong soft capsules (mainly containing ginsenosides) for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Patients diagnosed with acute ST-segment elevation myocardial infarction, acute non-ST-segment elevation myocardial infarction, or unstable angina according to Western medical standards. Inclusion Criteria.
- •Within 4 weeks post-PCI.
- •Aged between 18 and 80 years, both male and female.
- •Voluntarily participating in the clinical trial, having signed the informed consent form.
排除标准
- •Uncontrolled hypertension after medication (systolic BP >180mmHg or diastolic BP > 110mmHg).
- •Increased bleeding risk: history of hemorrhagic stroke; intracranial aneurysm; major trauma or surgery within the past month (including Exclusion Criteria bypass surgery); active bleeding disorders.
- •History of gastrointestinal ulcers or significant gastrointestinal bleeding.
- •Severe organic heart disease, such as LVEF < 35% or NYHA/Killip heart function grade IV.
- •History of malignant arrhythmias within the past year (arrhythmias affecting hemodynamics requiring medication or electrical cardioversion, or requiring CPR), congenital heart disease, or malignant tumors.
- •Severe liver or kidney dysfunction: ALT or AST ≥ 3×ULN, TBIL≥ 2×ULN, or creatinine clearance < 30ml/min.
- •Pregnant or lactating women.
- •Recent blood donation or significant blood loss within the past 3 months (≥400ml).
- •History of alcohol abuse (≥28 standard units/week for males, ≥21 standard units/week for females) or frequent alcohol consumption in the past 6 months (≥14 standard units/week).
- •History of drug abuse or dependence within the past year. Participation in other clinical trials and taking trial drugs within the past 3 months.
- •Allergy or intolerance to aspirin or P2Y12 receptor inhibitors.
- •Allergy to any components of the trial drug.
- •Other conditions deemed inappropriate for participation by the nvestigator
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 12 weeks
干预措施: Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins) (Drug)
Control group
Routine western medicine treatment (oral drug therapy and standard percutaneous coronary intervention) +Placebo capsule, 0.33g/ tablets, 2 tablets each time, twice a day. The treatment period is 12 weeks
干预措施: placebo capsule (Drug)
结局指标
主要结局
Changes in thromboelastography induced by AA, including R value, K value , α angle , MA value , CI, TPI， LY30, and AAYZL, before and after treatment, as assessed by thromboelastography.
时间窗: 12 weeks
This outcome measure will assess changes in thromboelastography induced by AA, including R value (reaction time), K value (coagulation time), αangle (alpha angle), MA value (maximum amplitude), CI (coagulation index), TPI (thrombodynamic potential index)， LY30 (amplitude at 30 minutes), and AAYZL Percentage platelet clotting inhibition of AA), before and after treatment. Data will be summarized based on the change in levels of each marker from baseline to post-treatment, and any significant changes will be noted.
Changes in thromboelastography induced by ADP, including R value, K value , α angle , MA value , CI, TPI， LY30, and ADPYZL, before and after treatment, as assessed by thromboelastography.
时间窗: 12 weeks
This outcome measure will assess changes in thromboelastography induced by ADP, including R value (reaction time), K value (coagulation time), αangle (alpha angle), MA value (maximum amplitude), CI (coagulation index), TPI (thrombodynamic potential index)， LY30 (amplitude at 30 minutes), and ADPYZL（ Percentage platelet clotting inhibition of ADP), before and after treatment. Data will be summarized based on the change in levels of each marker from baseline to post-treatment, and any significant changes will be noted.
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(12 weeks)
- Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry(12 weeks)
- Changes in endothelial function markers, including plasma soluble vascular cell adhesion molecule 1 (VCAM-1), soluble intercellular adhesion molecule 1 (ICAM-1), vascular hemophilic factor (vWF), before and after treatment, as assessed by ELISA(12 weeks)
- Changes in inflammatory markers, including serum hs-CRP, IL-11,IL-6,MCP-1,MMP-9,CD40L,before and after treatment, as assessed by ELISA.(12 weeks)
- ejection fraction(12 weeks)
- Changes in lipid markers, including TC, HDL-C, LDL-C, TG, lLPa, APO-A1, APO-B, before and after treatment, as assessed by enzymatic and immunoturbidimetric methods(12 weeks)
- white blood cell count and red blood cell count(12 weeks)
- hemoglobin levels(12 weeks)
- platelet count(12 weeks)
- Urine analysis of biochemical markers(12 weeks)
- Estimated glomerular filtration rate (GFR)(12 weeks)
- hematocrit levels(12 weeks)
- Urine analysis of cellular components(12 weeks)
- Cellular components in stool(12 weeks)
- liver function based on the enzyme levels(12 weeks)
- Stool appearance(12 weeks)
- Biochemical components in stool(12 weeks)
- liver function based on the bilirubin levels(12 weeks)
- Serum creatinine and blood urea nitrogen (BUN)(12 weeks)
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT)(12 weeks)
- Assessment of electrocardiogram (ECG) parameters, including QT interval, heart rate, and ST segment changes, before and after treatment(12 weeks)
- International normalized ratio (INR)(12 weeks)
- left ventricular end-diastolic internal diameter(12 weeks)
- mitral valve diastolic E/A ratio(12 weeks)