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Clinical Trials in China / NCT06425120
Recruiting Phase 4

Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease

NCT06425120 · tracked via the Priya Life Science China tracker
Sponsor
China National Center for Cardiovascular Diseases
Phase
Phase 4
Started
2024-06-01
Last updated
2025-09-08

Condition(s) studied

Coronary Heart Disease

Investigational drug(s) / intervention(s)

Xuesaitong Soft CapsulePlacebo

Xuesaitong Soft Capsule: Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g.

Placebo: Each participant in the placebo group will take matching placebo.

Study summary

This trials aims to assess, in 240 eligible patients with coronary heart disease, the effects on level of high-sensitivity C-reactive protein (hsCRP) changes from baseline to 12 weeks of Xuesaitong Soft Capsules.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years old 2. Chronic coronary artery disease: meet any of the following conditions, and the condition is stable for at least 3 months: 1. History of myocardial infarction 2. Have received coronary interventional therapy 3. There are symptoms of myocardial ischemia (such as chest pain) and objective evidence (stress electrocardiogram or stress myocardial perfusion imaging indicated myocardial ischemia or coronary artery stenosis ≥50% ) 3. High-sensitivity C-reactive protein ≥2mg/L 4. Currently taking moderate or above intensity statins lipid-lowering drugs 5. Currently taking antiplatelet drugs 6. Sign informed consent Exclusion Criteria: * Patients fulfilling any of the following criteria are not eligible for inclusion in this trial: 1. Acute coronary syndrome occurred or received percutaneous coronary intervention therapy within the past 3 months 2. Previously received coronary artery bypass grafting 3. Stroke occurred within the previous 3 months 4. Symptomatic heart failure (HF) in the past, or documented left ventricular ejection fraction \< 35% 5. Revascularization or surgical procedures are planned within the next 3 months 6. Progressive neuromuscular disease, or creatine kinase (CK) levels \> 3 times the normal upper limit (ULN) 7. Lupus, inflammatory bowel disease, severe arthritis and other inflammatory diseases 8. Immunosuppressants such as cyclosporine, tacrolimus, azathioprine, or systemic steroids are currently being taken or planned during the study 9. History of hereditary dyslipidemia such as familial hypercholesterolemia 10. There has been a change in lipid regulation treatment within the past 1 month, or there is a current adjustment plan 11. History of symptomatic non-traumatic cerebral hemorrhage at any time in the past 12. History of gastrointestinal bleeding or major surgery within the past 6 months 13. Use of Xuesaitong soft capsules or preparations containing the main ingredients of Xuesaitong in the past 1 month 14. There were clear adverse reactions to the main components of Xuesaitong in the past 15. Active liver disease, or alanine aminotransferase (ALT) levels \> 3 times the upper limit of normal (ULN) 16. Chronic kidney disease, or estimated glomerular filtration rate (eGFR) \<60ml/ (min×1.73m2) 17. Pregnancy or planned pregnancy, or breastfeeding 18. Malignant tumors, or other serious diseases with an estimated survival of less than 1 year 19. Mental disorders or communication disorders, cognitive impairment, or other serious medical conditions that may affect study participation 20. Have participated in or are participating in other clinical trials within the last 1 month 21. Poor adherence to follow-up or medication is known

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Fuwai Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Affiliated Hospital of Nantong University Nantong Jiangsu Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06425120 on ClinicalTrials.gov ↗ ← All trials in China