NCT06425120 Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease
| NCT ID | NCT06425120 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Coronary Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 240 participants in total. It began in 2024-06-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jing Li, MD, PhD
PRINCIPAL INVESTIGATOR
National Center for Cardiovascular Diseases
Frequently Asked Questions
Who can join the NCT06425120 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06425120 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06425120 currently recruiting?
Yes, NCT06425120 is actively recruiting participants. Contact the research team at jing.li@fwoxford.org for enrollment information.
Where is the NCT06425120 trial being conducted?
This trial is being conducted at Beijing, China, Nantong, China.
Who is sponsoring the NCT06425120 clinical trial?
NCT06425120 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Jing Li, MD, PhD at National Center for Cardiovascular Diseases. The trial plans to enroll 240 participants.