Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT06425120
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06425120
Study Brief:
Protocol Section:
NCT06425120