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

NCT06425120 | Recruiting Phase 4

• 1 other identifier: 2023-ZX074
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• hsCRP

  Changes in high-sensitivity C-reactive protein level from baseline at 12 weeks

  12 weeks

Secondary Outcomes (6)

• Other inflammation indicators

  12 weeks

• IPA

  12 weeks

• Vascular endothelial function

  12 weeks

• Blood lipid profiles

  12 weeks

• Seattle Angina Questionnaire

  12 weeks

Study Arms (2)

Xuesaitong Soft Capsule

EXPERIMENTAL

Each participant in the Xuesaitong Soft Capsule treatment group will take a daily dose of 1.32g.

Drug: Xuesaitong Soft Capsule

Placebo

PLACEBO COMPARATOR

Each participant in the placebo group will take matching placebo.

Drug: Placebo

Interventions

Xuesaitong Soft Capsule DRUG

Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g.

Also known as: LixuwangⓇ

Xuesaitong Soft Capsule

Placebo DRUG

Each participant in the placebo group will take matching placebo.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (2)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100087, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jing Li, MD, PhD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

• Jiamin Liu, MD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Li, MD, PhD

CONTACT

+86 (010) 6086 6077; jing.li@fwoxford.org

Yan Li, MD

CONTACT

+86 (010) 6086 6795; liyan@fuwai.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: JingLi, MD, PhD, professor

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)