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

NCT ID: NCT06618495

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-23
• Study Completion Date: 2025-11-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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 > 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dazhuo Shi, professor

Role: PRINCIPAL_INVESTIGATOR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2024XLA098-2

Identifier Type: -

Identifier Source: org_study_id