Coronary Heart Disease
Conditions
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.
Interventions
Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g.
DRUGPlacebo
Each participant in the placebo group will take matching placebo.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hsCRP | 12 weeks | Changes in high-sensitivity C-reactive protein level from baseline at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other inflammation indicators | 12 weeks | Changes in levels of interleukin-6, interleukin-10, interleukin-1β, tumor necrosis factor-α from baseline at 12 weeks |
| Vascular endothelial function | 12 weeks | Changes in intercellular adhesion molecule-1, von Willebrand factor, and endothelin-1 levels from baseline at 12 weeks |
| IPA | 12 weeks | Changes in level of inhibition of platelet aggregation from baseline at 12 weeks |
| Seattle Angina Questionnaire | 12 weeks | Changes in Seattle angina scores from baseline at 12 weeks |
| SF-36 | 12 weeks | Changes in Health Survey Scale (SF-36 Scale) scores from baseline at 12 weeks |
| Blood lipid profiles | 12 weeks | Changes in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, small low-density lipoprotein cholesterol, and triglyceride levels from baseline at 12 weeks |
Countries
China
Contacts
Primary ContactJing Li, MD, PhD
Backup ContactYan Li, MD
Outcome results
None listed