Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease

Coronary Heart Disease Clinical Trial

Official title:

Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425120
• Other study ID #: 2023-ZX074
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 31, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Jing Li, MD, PhD
• Phone: +86 (010) 6086 6077
• Email: jing.li[@]fwoxford.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 6 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 6 months

2. Previously received coronary artery bypass grafting

3. Stroke occurred within the previous 6 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Xuesaitong Soft Capsule
Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g.
• Placebo
Each participant in the placebo group will take matching placebo.

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hsCRP	Changes in high-sensitivity C-reactive protein level from baseline at 12 weeks	12 weeks
Secondary	Other inflammation indicators	Changes in levels of interleukin-6, interleukin-10, interleukin-1ß, tumor necrosis factor-a from baseline at 12 weeks	12 weeks
Secondary	IPA	Changes in level of inhibition of platelet aggregation from baseline at 12 weeks	12 weeks
Secondary	Vascular endothelial function	Changes in intercellular adhesion molecule-1, von Willebrand factor, and endothelin-1 levels from baseline at 12 weeks	12 weeks
Secondary	Blood lipid profiles	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	12 weeks
Secondary	Seattle Angina Questionnaire	Changes in Seattle angina scores from baseline at 12 weeks	12 weeks
Secondary	SF-36	Changes in Health Survey Scale (SF-36 Scale) scores from baseline at 12 weeks	12 weeks