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

Last updated: February 23, 2025
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Not Recruiting

Phase

3

Condition

Chest Pain

Cardiac Disease

Myocardial Ischemia

Treatment

placebo capsule

Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins)

Clinical Study ID

NCT06845254
2024XLA098-3
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients diagnosed with acute ST-segment elevation myocardial infarction, acutenon-ST-segment elevation myocardial infarction, or unstable angina according toWestern 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 consentform.

Exclusion

Exclusion Criteria:

  1. Uncontrolled hypertension after medication (systolic BP >180mmHg or diastolic BP > 110mmHg).

  2. Increased bleeding risk: history of hemorrhagic stroke; intracranial aneurysm; majortrauma or surgery within the past month (including Exclusion Criteria bypasssurgery); 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 gradeIV.

  5. History of malignant arrhythmias within the past year (arrhythmias affectinghemodynamics 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 creatinineclearance < 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/weekfor females) or frequent alcohol consumption in the past 6 months (≥14 standardunits/week).

  10. History of drug abuse or dependence within the past year. Participation in otherclinical 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

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: placebo capsule
Phase: 3
Study Start date:
March 01, 2025
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

    Beijing,
    China

    Site Not Available

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