RecruitingPhase 4NCT06425120

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


Sponsor

China National Center for Cardiovascular Diseases

Enrollment

240 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria9

  • 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

Exclusion Criteria22

  • 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

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Interventions

DRUGXuesaitong Soft Capsule

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.


Locations(2)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT06425120


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