Acute Coronary SyndromePhase 1/2NCT06618495
Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome
A Phase 1/2 study testing Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins) in people with Acute Coronary Syndrome, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2024to 25 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) it accords with the diagnostic criteria of western medicine for acute coronary syndrome.
- within 4 weeks after coronary intervention.
- 18 years old ≤ age ≤ 80 years old, male or female.
- voluntarily participate in this clinical trial, give informed consent and sign an informed consent form
Who cannot join
- (1) uncontrollable hypertension after drug treatment (systolic blood pressure \> 180mmHg, or diastolic blood pressure \> 110mmHg).
- increased risk of bleeding: previous history of hemorrhagic stroke; intracranial aneurysms; trauma or major surgery within 1 month (including bypass surgery); diseases currently suffering from active bleeding, etc.
- patients with history of digestive tract ulcer and massive gastrointestinal bleeding.
- severe organic heart disease, such as patients with LVEF \< 35% or NYHA/Killip cardiac function grade IV.
- those with a history of malignant arrhythmias (arrhythmias affected by hemodynamics, requiring drug or electrical cardioversion, or cardiopulmonary resuscitation), congenital heart disease or malignant tumor were considered unable to participate in the trial.
- severe hepatic and renal insufficiency: glutamic pyruvic transaminase (ALT) or aspartate oxaloacetic transaminase (AST) ≥ 3 × normal upper limit (ULN) or total bilirubin (TBIL) ≥ 2 × ULN; or creatinine clearance (Ccr \< 30ml/min).
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- Women in pregnancy (defined as positive blood pregnancy test) and lactating women.
- those with a history of blood donation or significant blood loss in the last 3 months (≥ 400ml).
- people with a previous history of alcoholism (i.e. men drink more than 28 standard units per week and women drink more than 21 standard units per week (1 standard unit contains 14g alcohol, such as 360mL beer or 25mL spirits or 150mL wine with 40% alcohol content); or screen those who drink regularly in the first 6 months (that is, more than 14 standard units per week).
- those with a history of drug abuse and drug dependence within one year before screening.
- those who have participated in other clinical trials and taken trial drugs in the past 3 months.
- people who are allergic or intolerant to aspirin or P2Y12 receptor inhibitors.
- those who are allergic to the ingredients of the test drugs.
- other situations in which the researchers think it is not appropriate to participate in this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Beijing, Beijing Municipality, 100091
About this study
Official title: Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome After Percutaneous Coronary Intervention
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).
- Conditions
- Acute Coronary Syndrome
- Being tested
- Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins)
- Keywords
- Acute coronary syndrome, traditional Chinese medicine, Total saponins of Panax notoginseng
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Drug: Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
hematocrit levels
Hematocrit will be reported as a percentage (%), and the number of participants with abnormal values will be summarized.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start23 Dec 2024
- Primary completion2 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dazhuo Shi, professor, Principal investigator, Xiyuan Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618495
- Sponsor's protocol ID
- 2024XLA098-2
- Status last verified
- Nov 2025
- First submitted
- 28 Jun 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06618495
- Acronym / sponsor ID
- 2024XLA098-2
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, traditional Chinese medicine, Total saponins of Panax notoginseng
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 2 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | 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 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) it accords with the diagnostic criteria of western medicine for acute coronary syndrome.
Key exclusion criteria (14 listed)
- (1) uncontrollable hypertension after drug treatment (systolic blood pressure \> 180mmHg, or diastolic blood pressure \> 110mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 4 weeks. | Drug | Intervention group |
Primary outcome
Transcriptome analysis of patients' platelets collected before and after treatment
Time frame: 4 weeks
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.
Metabolomics analysis of patients' platelets collected before and after treatment
Time frame: 4 weeks
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.
Proteomics analysis of patients' platelets collected before and after treatment
Time frame: 4 weeks
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.
18 secondary outcomes
Changes in platelet granule markers, including platelet factor 4 (PF4) and β-thromboglobulin, before and after treatment, as assessed by ELISA
Time frame: 4 weeks
Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry
Time frame: 4 weeks
white blood cell count and red blood cell count
Time frame: 4 weeks
hemoglobin levels
Time frame: 4 weeks
hematocrit levels
Time frame: 4 weeks
platelet count
Time frame: 4 weeks
Urine analysis of biochemical markers
Time frame: 4 weeks
Urine analysis of cellular components
Time frame: 4 weeks
Stool appearance
Time frame: 4 weeks
Biochemical components in stool
Time frame: 4 weeks
Cellular components in stool
Time frame: 4 weeks
liver function based on the enzyme levels
Time frame: 4 weeks
liver function based on the bilirubin levels
Time frame: 4 weeks
Serum creatinine and blood urea nitrogen (BUN)
Time frame: 4 weeks
Estimated glomerular filtration rate (GFR)
Time frame: 4 weeks
Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
Time frame: 4 weeks
International normalized ratio (INR)
Time frame: 4 weeks
Assessment of electrocardiogram (ECG) parameters, including QT interval, heart rate, and ST segment changes, before and after treatment
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dazhuo Shi, professor principal investigator
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins) in people with Acute Coronary Syndrome, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptome analysis of patients' platelets collected before and after treatment (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.