NCT06425120RecruitingPhase 4
Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease
Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 17 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Coronary artery disease
- NCT number
- NCT06425120
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 240
- From 1 Jun 2024 to the primary completion date, 30 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Patients fulfilling any of the following criteria are not eligible for inclusion in this trial:
- Acute coronary syndrome occurred or received percutaneous coronary intervention therapy within the past 3 months
- Previously received coronary artery bypass grafting
- Stroke occurred within the previous 3 months
- Symptomatic heart failure (HF) in the past, or documented left ventricular ejection fraction \< 35%
- Revascularization or surgical procedures are planned within the next 3 months
- Progressive neuromuscular disease, or creatine kinase (CK) levels \> 3 times the normal upper limit (ULN)
- Lupus, inflammatory bowel disease, severe arthritis and other inflammatory diseases
- Immunosuppressants such as cyclosporine, tacrolimus, azathioprine, or systemic steroids are currently being taken or planned during the study
- History of hereditary dyslipidemia such as familial hypercholesterolemia
- There has been a change in lipid regulation treatment within the past 1 month, or there is a current adjustment plan
- History of symptomatic non-traumatic cerebral hemorrhage at any time in the past
- History of gastrointestinal bleeding or major surgery within the past 6 months
- Use of Xuesaitong soft capsules or preparations containing the main ingredients of Xuesaitong in the past 1 month
- There were clear adverse reactions to the main components of Xuesaitong in the past
- Active liver disease, or alanine aminotransferase (ALT) levels \> 3 times the upper limit of normal (ULN)
- Chronic kidney disease, or estimated glomerular filtration rate (eGFR) \<60ml/ (min×1.73m2)
- Pregnancy or planned pregnancy, or breastfeeding
- Malignant tumors, or other serious diseases with an estimated survival of less than 1 year
- Mental disorders or communication disorders, cognitive impairment, or other serious medical conditions that may affect study participation
- Have participated in or are participating in other clinical trials within the last 1 month
- Poor adherence to follow-up or medication is known
Who the study is looking for
- Age ≥18 years old
- Chronic coronary artery disease: meet any of the following conditions, and the condition is stable for at least 3 months:
- History of myocardial infarction
- Have received coronary interventional therapy
- 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% )
- High-sensitivity C-reactive protein ≥2mg/L
- Currently taking moderate or above intensity statins lipid-lowering drugs
- Currently taking antiplatelet drugs
- Sign informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.