Xuesaitong soft capsules to lower inflammation and improve risk markers in people with coronary heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 4 trial enrolling 240 adults with stable coronary heart disease and elevated hsCRP. Participants are randomized to receive Xuesaitong soft capsules (1.32 g/day) or matched placebo for 12 weeks with clinic follow-up. The primary outcome is change in high-sensitivity C-reactive protein (hsCRP) from baseline to 3 months; secondary outcomes include other inflammatory markers, platelet aggregation, endothelial function indicators, blood lipids, and patient-reported angina and quality-of-life scores. Safety and adverse events are monitored throughout, and a generalized linear mixed effects model will be used for the primary efficacy analysis with standard chi-square testing for safety comparisons.

Why it matters

Who can join: the full rules

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

Where it's running

• Fuwai Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Affiliated Hospital of Nantong University
  Nantong, Jiangsu, China Not yet recruiting

Study contacts

• Principal investigator: Jing Li, MD, PhD — National Center for Cardiovascular Diseases
• Study coordinator: Jing Li, MD, PhD
• Email: jing.li@fwoxford.org
• Phone: +86 (010) 6086 6077

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.