Clinical Trials in China / NCT06845254
Starting soon
Phase 3
Clinical Study on the Intervention of Xuesaitong Soft Capsules in Post-Intervention Patients with Acute Coronary Syndrome and Clinical Research Protocol
NCT06845254 · tracked via the Priya Life Science China tracker
Condition(s) studied
Acute Coronary Syndrome
Investigational drug(s) / intervention(s)
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.
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.
Study 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
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 outcome measure(s)
- 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. — 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. — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing | China |
More Xiyuan Hospital of China Academy of Chinese Medical Sciences trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06845254 on ClinicalTrials.gov ↗ ← All trials in China