Clinical trial NCT06425120: Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease
Official title: Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-05-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: In this multicenter, randomized, double-blind, placebo-controlled trial in patients with coronary heart disease,240 eligible patients aged ≥18 years will be randomized to receive placebo or Xuesaitong Soft Capsules(1.32g/d) and be followed up for 3 months. The primary endpoint of this study is hsCRP change from baseline to 3 months. The secondary endpoint is the changes of following indicators or scores from baseline to 3 months:(Ⅰ)other inflammation indicators except for hsCRP. (Ⅱ) inhibition of platelet aggregation; (Ⅲ)endothelial function indicators; (Ⅳ)blood lipid levels; (Ⅴ) seattle angina questionnaire score; (Ⅵ)36-item short form health survey score. The safety of using Xuesaitong soft capsules in patients with coronary heart disease will also be evaluated. The generalized linear mixed effects model will be used to evaluate the efficacy endpoint for the "full analysis set". For the safety analysis set, Chi-square test will be used to evaluate the safety endpoint.

Eligibility criteria: 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 6 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 6 months
  2. Previously received coronary artery bypass grafting
  3. Stroke occurred within the previous 6 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 outcomes:
measure: hsCRP
timeFrame: 12 weeks
Secondary outcomes:
measure: Other inflammation indicators
timeFrame: 12 weeks
measure: IPA
timeFrame: 12 weeks
measure: Vascular endothelial function
timeFrame: 12 weeks
measure: Blood lipid profiles
timeFrame: 12 weeks
measure: Seattle Angina Questionnaire
timeFrame: 12 weeks
measure: SF-36
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: National Center for Cardiovascular Diseases
name: Jing Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Cardiovascular Diseases
name: Jiamin Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: