Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, China
NCT Number: NCT06845254
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Phase 3
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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: 12 weeks
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: 12 weeks
This outcome measure will assess changes in platelet granule 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. 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: 12 weeks
Changes in inflammatory markers, including serum high-sensitivity C-reactive protein (hs-CRP), interleukin 11 (IL-11), interleukin 6 (IL-6), monocyte chemotactic protein 1 (MCP-1), matrix metalloproteinase-9 (MMP-9), and leukocyte differentiation antigen40 ligand (CD40L) 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: 12 weeks
Ejection fraction is a measurement of the percentage of blood pumped out of the heart with each contraction(%). The number of participants with values outside the normal range will be reported, along with any significant changes from baseline.
Time frame: 12 weeks
This outcome measure will assess changes in lipid markers including total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), lipoprotein a (LPa), apolipoprotein A1 (APO-A1), apolipoprotein B (APO-B),before and after treatment. Both markers will be measured using enzymatic and immunoturbidimetric methods, and reported in consistent units (mmol/L).
Time frame: 12 weeks
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: 12 weeks
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: 12 weeks
Hematocrit will be reported as a percentage (%), and the number of participants with abnormal values will be summarized.
Time frame: 12 weeks
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: 12 weeks
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: 12 weeks
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: 12 weeks
the 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: 12 weeks
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: 12 weeks
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: 12 weeks
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: 12 weeks
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: 12 weeks
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: 12 weeks
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: 12 weeks
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: 12 weeks
INR will be reported as a unitless value. Participants with abnormal INR values or significant changes from baseline will be recorded.
Time frame: 12 weeks
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: 12 weeks
Left ventricular end-diastolic internal diameter (LVEDD) is obtained by measuring the widest point of the left ventricle at its maximum diameter(mm). The number of participants with values outside the normal range will be reported, along with any significant changes from baseline.
Time frame: 12 weeks
The mitral valve diastolic E/A ratio is a measurement used in echocardiography to assess the diastolic function of the left ventricle. It refers to the ratio of the early (E) to late (A) diastolic filling velocities of the left ventricle, as measured by Doppler ultrasound of the mitral valve.. The number of participants with values outside the normal range will be reported, along with any significant changes from baseline.
Contact information is provided by the study sponsor or research team.
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Other
Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome After Percutaneous Coronary Intervention
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07721649
Acute Coronary Syndrome, Behavior
Cologne, Germany
View Trial DetailsNCT07684469
Acute Coronary Syndrome, Cardiovascular Diseases
View Trial DetailsNCT07563231
Acute Coronary Syndrome, Arterial Occlusive Diseases
Geneva, Switzerland
View Trial DetailsNCT07622485
Acute Coronary Syndrome, Arrhythmias, Cardiac
Yongin, Gyeonggi-do, South Korea
View Trial Details