Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome After Percutaneous Coronary Intervention
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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Title: Clinical Study on the Intervention of Xuesaitong Soft Capsules
in Post-Intervention Patients with Acute Coronary Syndrome and
Exploration of Molecular Mechanisms Clinical Research Protocol
ID: 2024XLA098-2
Data: May 20, 2024

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Clinical Research Protocol
Title
Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule
in the Treatment of Acute Coronary Syndrome After Percutaneous
Coronary Intervention
Version
Number
2024XLA098-2
Responsible
Institution
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Target
Population
Patients with Acute Coronary Syndrome (ACS) after Percutaneous
Target Population Coronary Intervention (PCI), both male and
female, aged between 18 and 80 years.
Objective
To interpret the microcosmic manifestations of ACS development
using multi-omics technologies, explore key biomarkers and the
correlation Objective between disease and syndrome, and elucidate
the macro and microcosmic manifestations and biological basis of
Xuesaitong soft capsule in the treatment of ACS from multiple
perspectives.
Study Design
Single-center, open-label, exploratory clinical study.
Sample Size
50 ACS patients post-PCI in an open-label group.
Study
Duration
From October 13, 2024, to December 1, 2026.
Inclusion
Criteria
(1) 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.
(2) Within 4 weeks post-PCI.
(3) Aged between 18 and 80 years, both male and female.
(4) Voluntarily participating in the clinical trial, having signed the
informed consent form.

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Exclusion
Criteria
(1) Uncontrolled hypertension after medication (systolic BP >
180mmHg or diastolic BP > 110mmHg).
(2) 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.
(3) History of gastrointestinal ulcers or significant gastrointestinal
bleeding.
(4) Severe
organic
heart
disease,
such
as
LVEF <
35% or
NYHA/Killip heart function grade IV.
(5) 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.
(6) Severe liver or kidney dysfunction: ALT or AST ≥3×ULN, TBIL
≥2×ULN, or creatinine clearance < 30ml/min.
(7) Pregnant or lactating women.
(8) Recent blood donation or significant blood loss within the past 3
months (≥400ml).
(9) 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).
(10) History of drug abuse or dependence within the past year.
Participation in other clinical trials and taking trial drugs within the
past 3 months.
(11) Allergy or intolerance to aspirin or P2Y12 receptor inhibitors.
(12) Allergy to any components of the trial drug.
(13) Other conditions deemed inappropriate for participation by the
investigator.

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Medication
Information
Trial Drug: Xuesaitong Soft Capsule.
Main Component: Panax Notoginseng Saponins.
Dosage Form: Capsule.
Dosage and Administration: Orally after meals, 0.33g per capsule, 2
capsules per dose, twice daily.
Storage Conditions: Room temperature, cool, dry place.
Medication
Regimen
Conventional Western medical treatment (oral medication and
standard PCI) combined with Xuesaitong soft capsule, 0.33g per
capsule, 2 capsules per dose, twice daily for 4 weeks.
Study
Procedure
Participants who meet the diagnostic criteria, inclusion, and exclusion
criteria, and have signed the informed consent form will be included
in the study. The open-label study period is 4 weeks, including 2
visits: Visit 1 (-1D to 0D) and Visit 2 (4w ± 3d), with no follow-up
period.
Evaluation
Criteria
(1) General Information: Demographic data, physical examination,
medical history, allergy history, smoking and alcohol history,
concomitant medications.
(2)
Multi-omics
Analysis:
Including
platelet
transcriptomics,
metabolomics, proteomics, microbiomics.
(3) Platelet Function: platelet granule markers (PF4 and β-TG),
surface
activation
markers
(P-selectin/CD62P,
GPIIb/IIIa
complex/CD41/CD61), platelet-leukocyte aggregation (CD41 and
CD15).
(4) Safety Indicators: Routine blood, urine, and stool tests (including
occult blood), liver and kidney function tests, ECG, coagulation
function, and adverse event recording.
Statistical
Analysis Plan
1. Analysis Data Sets
1.1 Full Analysis Set (FAS): Defined according to the ITT principle,
including all enrolled participants who received at least one
treatment.

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1.2 Per-Protocol Set (PPS): Includes participants who met inclusion
criteria,
completed
treatment
and
follow-up,
had
medication
compliance between 80-120%, did not use concomitant medications
affecting efficacy evaluation, had complete main outcome data, and
no major protocol violations.
1.3 Safety Set (SS): Includes all enrolled participants who received
at least one treatment. Baseline data analysis will be conducted
separately for FAS and PPS. Efficacy indicators will be analyzed for
both FAS and PPS. Safety and adverse events will be analyzed for
SS.
2. Statistical Method Description
2.1 Enrollment Analysis: List the number of enrolled and completed
cases, and determine the analysis data sets (PPS, SS).
2.2 Demographic and Baseline Analysis: Descriptive statistics for
demographic data and other baseline characteristics: Continuous
variables: Calculate the number, mean, standard deviation, median,
minimum, and maximum values. Categorical and ordinal data:
Calculate frequencies and proportions. Inferential statistical results
(P-values) will be listed as descriptive results. Age factors should be
considered in data analysis, and data should be stratified or grouped
by different age groups.
2.3 Efficacy
Analysis:
Primary
Efficacy
Indicators:
Evaluate
treatment effects through multi-omics analysis and platelet function
indicators. Use descriptive and inferential statistical methods such as
t-tests, chi-square tests, and Cox regression analysis to compare pre-
and
post-treatment
differences.
Secondary
Efficacy
Indicators:
Include safety indicators and adverse event records. Use descriptive
statistical methods such as frequency analysis and percentage
calculations to describe the incidence and severity of adverse events.

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2.4 Safety Analysis: Number and rate of laboratory indicators or
physical examination abnormalities after treatment. List abnormal
laboratory indicators, abnormal physical examination cases, and
clinical interpretations.
2.5 Laboratory Data: Analyze changes in laboratory test results
before
and
after
treatment
using
paired
t-tests
or
Wilcoxon
signed-rank tests.
2.6 Adverse Events: Describe the types, frequencies, and severities
of adverse events using chi-square tests or Fisher's exact tests for
comparisons.
2.7 Multiple Comparison Adjustments: For multivariable statistical
analyses, use Bonferroni correction or Holm-Bonferroni method to
adjust significance levels and control type I error rates.
2.8 Critical Assumption Verification: Certain statistical methods
require critical assumptions such as normality and homogeneity of
variance. Verification methods include: Normality Test: Shapiro-Wilk
test or Kolmogorov-Smirnov test. Homogeneity of Variance Test:
Levene's test or Bartlett's test. This statistical analysis plan ensures
the scientific rigor and reliability of data analysis. All statistical
analyses will be performed using SAS or R software by professional
statisticians