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Coronary Heart DiseasePhase 4NCT06425120

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

A Phase 4 study testing Xuesaitong Soft Capsule in people with Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease
What is being tested?
Xuesaitong Soft Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
2 sitesChina
Study dates
1 Jun 2024to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Currently taking moderate or above intensity statins lipid-lowering drugs
  • Currently taking antiplatelet drugs
  • Sign informed consent

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jing Li, MD, PhD contact

+86 (010) 6086 6077

jing.li@fwoxford.org

Yan Li, MD contact

+86 (010) 6086 6795

liyan@fuwai.com

China2 sites, 2 recruiting

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100087

    Ying Sun, BA, 18310888612, ying.sun@fwoxford.org

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu

    Linsheng Shi, MD, PhD, +86 13813719088, shlsh@139.com

    Linsheng Shi, MD, PhD

    Not yet recruiting

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
Xuesaitong Soft Capsule, Placebo
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xuesaitong Soft CapsuleDrug

    Also called LixuwangⓇ

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

  • PlaceboDrug

    Each participant in the placebo group will take matching placebo.

Study groups in NCT06425120
Study groupRoleWhat they receive
Xuesaitong Soft CapsuleExperimentalEach participant in the Xuesaitong Soft Capsule treatment group will take a daily dose of 1.32g.
Receives: Drug: Xuesaitong Soft Capsule
PlaceboPlacebo comparatorEach participant in the placebo group will take matching placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hsCRP

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

    Measured: 12 weeks

Secondary outcomes (6)

  1. Other inflammation indicators

    Changes in levels of interleukin-6, interleukin-10, interleukin-1β, tumor necrosis factor-α from baseline at 12 weeks

    Measured: 12 weeks

  2. IPA

    Changes in level of inhibition of platelet aggregation from baseline at 12 weeks

    Measured: 12 weeks

  3. Vascular endothelial function

    Changes in intercellular adhesion molecule-1, von Willebrand factor, and endothelin-1 levels from baseline at 12 weeks

    Measured: 12 weeks

  4. 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

    Measured: 12 weeks

  5. Seattle Angina Questionnaire

    Changes in Seattle angina scores from baseline at 12 weeks

    Measured: 12 weeks

  6. SF-36

    Changes in Health Survey Scale (SF-36 Scale) scores from baseline at 12 weeks

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2024
  2. Study start1 Jun 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06425120
Sponsor's protocol ID
2023-ZX074
Status last verified
Aug 2025
First submitted
17 May 2024
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Xuesaitong Soft Capsule in people with Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jing Li, MD, PhD (+86 (010) 6086 6077, jing.li@fwoxford.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hsCRP (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06425120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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