Not yet recruiting NCT06845254
Clinical Study on the Intervention of Xuesaitong Soft Capsules in Post-Intervention Patients with Acute Coronary Syndrome and Clinical Research Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins), placebo capsule.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndrome. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome After Percutaneous Coronary Intervention
Overview
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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- 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. [Time frame: 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. [Time frame: 12 weeks]
Secondary outcome measures (12)
- Changes in platelet granule markers, including platelet factor 4 (PF4) and β-thromboglobulin, before and after treatment, as assessed by ELISA [Time frame: 12 weeks]
- Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry [Time frame: 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 [Time frame: 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. [Time frame: 12 weeks]
- ejection fraction [Time frame: 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 [Time frame: 12 weeks]
- white blood cell count and red blood cell count [Time frame: 12 weeks]
- hemoglobin levels [Time frame: 12 weeks]
- hematocrit levels [Time frame: 12 weeks]
- platelet count [Time frame: 12 weeks]
- Urine analysis of biochemical markers [Time frame: 12 weeks]
- Urine analysis of cellular components [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xiyuan Hospital, China Academy of Chinese Medical Sciences — Beijing
Identifiers
NCT: NCT06845254 · 2024XLA098-3