Clinical Study on the Intervention of Xuesaitong Soft Capsules in Post-Intervention Patients with Acute Coronary Syndrome and Clinical Research Protocol

Официальное название

Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome After Percutaneous Coronary Intervention

Обзор

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.

Вмешательства

• Препарат Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins)
  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.
• Препарат placebo capsule
  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 12weeks.

Первичные конечные точки

• 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. [Срок оценки: 12 weeks]
• 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. [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

• Changes in platelet granule markers, including platelet factor 4 (PF4) and β-thromboglobulin, before and after treatment, as assessed by ELISA [Срок оценки: 12 weeks]
• Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 12 weeks]
• ejection fraction [Срок оценки: 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 [Срок оценки: 12 weeks]
• white blood cell count and red blood cell count [Срок оценки: 12 weeks]
• hemoglobin levels [Срок оценки: 12 weeks]
• hematocrit levels [Срок оценки: 12 weeks]
• platelet count [Срок оценки: 12 weeks]
• Urine analysis of biochemical markers [Срок оценки: 12 weeks]
• Urine analysis of cellular components [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xiyuan Hospital, China Academy of Chinese Medical Sciences — Пекин

Идентификаторы

NCT: NCT06845254 · 2024XLA098-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗