Clinical trial NCT06845254: Clinical Study on the Intervention of Xuesaitong Soft Capsules in Post-Intervention Patients with Acute Coronary Syndrome and Clinical Research Protocol
Official title: Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary syndrome
traditional Chinese medicine
Total saponins of Panax notoginseng
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Within 4 weeks post-PCI.
3. Aged between 18 and 80 years, both male and female.
4. Voluntarily participating in the clinical trial, having signed the informed consent form.

Exclusion Criteria:

1. Uncontrolled hypertension after medication (systolic BP \>180mmHg or diastolic BP \> 110mmHg).
2. 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.
3. History of gastrointestinal ulcers or significant gastrointestinal bleeding.
4. Severe organic heart disease, such as LVEF \< 35% or NYHA/Killip heart function grade IV.
5. 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.
6. Severe liver or kidney dysfunction: ALT or AST ≥ 3×ULN, TBIL≥ 2×ULN, or creatinine clearance \< 30ml/min.
7. Pregnant or lactating women.
8. Recent blood donation or significant blood loss within the past 3 months (≥400ml).
9. 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).
10. History of drug abuse or dependence within the past year. Participation in other clinical trials and taking trial drugs within the past 3 months.
11. Allergy or intolerance to aspirin or P2Y12 receptor inhibitors.
12. Allergy to any components of the trial drug.
13. Other conditions deemed inappropriate for participation by the nvestigator

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in platelet granule markers, including platelet factor 4 (PF4) and β-thromboglobulin, before and after treatment, as assessed by ELISA
timeFrame: 12 weeks
measure: Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: ejection fraction
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: white blood cell count and red blood cell count
timeFrame: 12 weeks
measure: hemoglobin levels
timeFrame: 12 weeks
measure: hematocrit levels
timeFrame: 12 weeks
measure: platelet count
timeFrame: 12 weeks
measure: Urine analysis of biochemical markers
timeFrame: 12 weeks
measure: Urine analysis of cellular components
timeFrame: 12 weeks
measure: Stool appearance
timeFrame: 12 weeks
measure: Biochemical components in stool
timeFrame: 12 weeks
measure: Cellular components in stool
timeFrame: 12 weeks
measure: liver function based on the enzyme levels
timeFrame: 12 weeks
measure: liver function based on the bilirubin levels
timeFrame: 12 weeks
measure: Serum creatinine and blood urea nitrogen (BUN)
timeFrame: 12 weeks
measure: Estimated glomerular filtration rate (GFR)
timeFrame: 12 weeks
measure: Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
timeFrame: 12 weeks
measure: International normalized ratio (INR)
timeFrame: 12 weeks
measure: Assessment of electrocardiogram (ECG) parameters, including QT interval, heart rate, and ST segment changes, before and after treatment
timeFrame: 12 weeks
measure: left ventricular end-diastolic internal diameter
timeFrame: 12 weeks
measure: mitral valve diastolic E/A ratio
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
Study officials:
References: