Clinical Study on the Intervention of Xuesaitong Soft Capsules in Post-Intervention Patients with Acute Coronary Syndrome and Clinical Research Protocol

NCT ID: NCT06845254

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-12-01

Brief Summary

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To assess the effects of Xuesaitong soft capsules on platelet function, clinical efficacy, prognosis, and safety in the treatment of acute coronary syndrome, 400 patients with acute coronary syndrome who underwent PCI were treated with Xuesaitong soft capsules (mainly containing ginsenosides) for 12 weeks.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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 12 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 12 weeks.

Control group

Routine western medicine treatment (oral drug therapy and standard percutaneous coronary intervention) +Placebo capsule, 0.33g/ tablets, 2 tablets each time, twice a day. The treatment period is 12 weeks

Group Type PLACEBO_COMPARATOR

placebo capsule

Intervention Type DRUG

Routine western medicine treatment (oral drug therapy and standard percutaneous coronary intervention) + placebo capsule, 0.33g/ tablets, 2 tablets each time, twice a day. The treatment period is 12weeks.

Interventions

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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 12 weeks.

Intervention Type DRUG

placebo capsule

Routine western medicine treatment (oral drug therapy and standard percutaneous coronary intervention) + placebo capsule, 0.33g/ tablets, 2 tablets each time, twice a day. The treatment period is 12weeks.

Intervention Type DRUG

Eligibility Criteria

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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.

Exclusion Criteria

1. Uncontrolled hypertension after medication (systolic BP \>180mmHg or diastolic BP \> 110mmHg).
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 nvestigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Dazhuo Shi, professor

Role: CONTACT

010-62835303

Facility Contacts

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Dazhuo Shi

Role: primary

17611487217

Other Identifiers

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2024XLA098-3

Identifier Type: -

Identifier Source: org_study_id

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