Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome

NCT06618495 | Completed Phase 1 DMC

• 1 other identifier: 2024XLA098-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Acute coronary syndrome; traditional Chinese medicine; Total saponins of Panax notoginseng

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  4 weeks

• Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry

  4 weeks

• white blood cell count and red blood cell count

  4 weeks

• hemoglobin levels

  4 weeks

• hematocrit levels

  4 weeks

Study Arms (1)

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

Drug: Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins)

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) it accords with the diagnostic criteria of western medicine for acute coronary syndrome.
• (2) within 4 weeks after coronary intervention.
• (3) 18 years old ≤ age ≤ 80 years old, male or female.
• (4) voluntarily participate in this clinical trial, give informed consent and sign an informed consent form

You may not qualify if:

• (1) uncontrollable hypertension after drug treatment (systolic blood pressure \> 180mmHg, or diastolic blood pressure \> 110mmHg).
• (2) 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.
• (3) patients with history of digestive tract ulcer and massive gastrointestinal bleeding.
• (4) severe organic heart disease, such as patients with LVEF \< 35% or NYHA/Killip cardiac function grade IV.
• (5) 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.
• (6) 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).
• (7) Women in pregnancy (defined as positive blood pregnancy test) and lactating women.
• (8) those with a history of blood donation or significant blood loss in the last 3 months (≥ 400ml).
• (9) 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).
• (10) those with a history of drug abuse and drug dependence within one year before screening.
• (11) those who have participated in other clinical trials and taken trial drugs in the past 3 months.
• (12) people who are allergic or intolerant to aspirin or P2Y12 receptor inhibitors.
• (13) those who are allergic to the ingredients of the test drugs.
• (14) other situations in which the researchers think it is not appropriate to participate in this experiment.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China

Beijing, Beijing Municipality, 100091, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Dazhuo Shi, professor

  Xiyuan Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: October 1, 2024
• Study Start: December 23, 2024
• Primary Completion: November 2, 2025
• Study Completion: November 25, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)