Clinical trial NCT06618495: Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome
Official title: Clinical Study and Molecular Mechanism of Xuesaitong Soft Capsule in the Treatment of Acute Coronary Syndrome After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary syndrome
traditional Chinese medicine
Total saponins of Panax notoginseng
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* (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

Exclusion Criteria:

* (1) uncontrollable hypertension after drug treatment (systolic blood pressure \&gt; 180mmHg, or diastolic blood pressure \&gt; 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 \&lt; 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 \&lt; 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.

Primary outcomes:
measure: Transcriptome analysis of patients' platelets collected before and after treatment
timeFrame: 4 weeks
measure: Metabolomics analysis of patients' platelets collected before and after treatment
timeFrame: 4 weeks
measure: Proteomics analysis of patients' platelets collected before and after treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in platelet granule markers, including platelet factor 4 (PF4) and β-thromboglobulin, before and after treatment, as assessed by ELISA
timeFrame: 4 weeks
measure: Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry
timeFrame: 4 weeks
measure: white blood cell count and red blood cell count
timeFrame: 4 weeks
measure: hemoglobin levels
timeFrame: 4 weeks
measure: hematocrit levels
timeFrame: 4 weeks
measure: platelet count
timeFrame: 4 weeks
measure: Urine analysis of biochemical markers
timeFrame: 4 weeks
measure: Urine analysis of cellular components
timeFrame: 4 weeks
measure: Stool appearance
timeFrame: 4 weeks
measure: Biochemical components in stool
timeFrame: 4 weeks
measure: Cellular components in stool
timeFrame: 4 weeks
measure: liver function based on the enzyme levels
timeFrame: 4 weeks
measure: liver function based on the bilirubin levels
timeFrame: 4 weeks
measure: Serum creatinine and blood urea nitrogen (BUN)
timeFrame: 4 weeks
measure: Estimated glomerular filtration rate (GFR)
timeFrame: 4 weeks
measure: Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
timeFrame: 4 weeks
measure: International normalized ratio (INR)
timeFrame: 4 weeks
measure: Assessment of electrocardiogram (ECG) parameters, including QT interval, heart rate, and ST segment changes, before and after treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Dazhuo Shi, professor
role: PRINCIPAL_INVESTIGATOR
References: