To evaluate the platelet function, clinical efficacy, prognosis and safety of Xuesaitong soft capsule in the treatment of acute coronary syndrome, 50 patients with acute coronary syndrome after PCI were treated with Xuesaitong soft capsule (mainly Panax notoginseng saponins) for 4 weeks. The macroscopic and microscopic characterization and biological basis of Xuesaitong soft capsule in the treatment of acute coronary syndrome were explained by multi-group techniques (platelet transcription group, metabolic group, protein group).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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 4 weeks.
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Beijing, Beijing Municipality, China
Transcriptome analysis of patients' platelets collected before and after treatment
This measure involves the collection of patients' platelets for comprehensive transcriptome analysis. This analysis aims to identify changes in gene expression profiles before and after treatment. Data will be summarized based on differentially expressed genes, providing insights into the impact of treatment on platelet function at the transcriptional level.
Time frame: 4 weeks
Metabolomics analysis of patients' platelets collected before and after treatment
This measure involves the collection of patients' platelets for comprehensive metabolomics analysis. This analysis aims to identify changes in metabolic pathways and metabolites before and after treatment. Data will be summarized based on identified metabolites and altered metabolic pathways, which will help elucidate the treatment's effects on platelet function at the metabolic level.
Time frame: 4 weeks
Proteomics analysis of patients' platelets collected before and after treatment
This measure involves the collection of patients' platelets for comprehensive proteomics analysis. This analysis aims to identify changes in protein expression patterns before and after treatment. Data will be summarized based on differentially expressed proteins, providing insights into the treatment's impact on platelet function at the proteomic level.
Time frame: 4 weeks
Changes in platelet granule markers, including platelet factor 4 (PF4) and β-thromboglobulin, before and after treatment, as assessed by ELISA
This outcome measure will assess changes in platelet granule markers, including platelet factor 4 (PF4) and β-thromboglobulin, before and after treatment. Both markers will be measured using enzyme-linked immunosorbent assay (ELISA) and reported in consistent units (pg/mL). 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.
Time frame: 4 weeks
Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry
This outcome measure involves the detection of changes in platelet surface activation markers, including P-selectin (CD62P) and the GPIIb/IIIa complex (CD41/CD61), using flow cytometry. Additionally, platelet-neutrophil aggregation will be assessed by measuring the co-expression of CD41 (platelet marker) and CD15 (neutrophil marker). These analyses will quantify the impact of treatment on platelet activation and the interaction between platelets and neutrophils, with results presented as mean fluorescence intensity for each marker. Changes will be compared before and after treatment.
Time frame: 4 weeks
white blood cell count and red blood cell count
The white blood cell count and red blood cell count will be measured in cells per microliter (cells/µL). Data will be summarized by the number of participants with values outside the normal reference range, and any significant changes from baseline will be reported.
Time frame: 4 weeks
hemoglobin levels
Hemoglobin will be measured in grams per deciliter (g/dL). The number of participants with values outside the normal range will be reported, along with any significant changes from baseline.
Time frame: 4 weeks
hematocrit levels
Hematocrit will be reported as a percentage (%), and the number of participants with abnormal values will be summarized.
Time frame: 4 weeks
platelet count
Platelet count will be measured in platelets per microliter (platelets/µL). Participants with values outside the normal range will be recorded, along with any significant changes from baseline.
Time frame: 4 weeks
Urine analysis of biochemical markers
Urine glucose, protein, and ketones will be measured qualitatively (e.g., negative, trace, 1+, 2+) or quantitatively (e.g., mg/dL). Specific gravity will be measured as a ratio. Data will be summarized by the number of participants with abnormal levels or significant changes from baseline for each parameter.
Time frame: 4 weeks
Urine analysis of cellular components
Red blood cells (RBCs), white blood cells (WBCs), and epithelial cells will be measured as the number of cells per high-power field (HPF). Data will be summarized by identifying any abnormal findings (e.g., hematuria or pyuria) or significant changes from baseline.
Time frame: 4 weeks
Stool appearance
he consistency and color of stool will be evaluated. Stool color will be categorized (e.g., light brown, green, dark brown), and stool consistency will be assessed on a scale ranging from loose to hard. Data will be presented as categories for stool color and consistency grades.
Time frame: 4 weeks
Biochemical components in stool
The presence of blood, mucus, or parasites will be assessed using qualitative measures. Results will be reported as "positive" or "negative" for each component (e.g., blood present: yes/no).
Time frame: 4 weeks
Cellular components in stool
Stool will be examined for cellular components such as red and white blood cells. The number of cells per high-power field (HPF) will be recorded and summarized as mean counts (e.g., number of red blood cells/HPF).
Time frame: 4 weeks
liver function based on the enzyme levels
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) will be measured in units per liter (U/L). Data will be summarized by the number of participants with values outside the normal reference range for each enzyme, and significant changes from baseline will be noted.
Time frame: 4 weeks
liver function based on the bilirubin levels
Total bilirubin will be measured in milligrams per deciliter (mg/dL). Participants with abnormal bilirubin levels or significant changes from baseline will be reported.
Time frame: 4 weeks
Serum creatinine and blood urea nitrogen (BUN)
Both will be measured in milligrams per deciliter (mg/dL). Data will be summarized by the number of participants with levels outside the normal reference range for each parameter, and significant changes from baseline will be noted.
Time frame: 4 weeks
Estimated glomerular filtration rate (GFR)
GFR will be estimated and reported in milliliters per minute per 1.73 m² (mL/min/1.73 m²). Participants with abnormal GFR values or significant changes from baseline will be recorded.
Time frame: 4 weeks
Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
Both will be measured in seconds (s). Data will be summarized by the number of participants with values outside the normal reference range for each parameter, and significant changes from baseline will be noted.
Time frame: 4 weeks
International normalized ratio (INR)
INR will be reported as a unitless value. Participants with abnormal INR values or significant changes from baseline will be recorded.
Time frame: 4 weeks
Assessment of electrocardiogram (ECG) parameters, including QT interval, heart rate, and ST segment changes, before and after treatment
This measure involves evaluating various ECG parameters to monitor cardiac electrical activity. Specifically, it includes the measurement of the QT interval, heart rate, and any changes in the ST segment. The ECG recordings will be analyzed before and after treatment to assess the impact on cardiac function. Data will be summarized by the measurement of these parameters and any significant deviations from normal ranges
Time frame: 4 weeks
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