## Protocol Section
### Identification Module
**NCT ID:** NCT06425120

**Brief Title:** Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease

**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

#### Organization Study ID Info
**ID:** 2023-ZX074
#### Organization
**Class:** OTHER_GOV
**Full Name:** China National Center for Cardiovascular Diseases
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** China National Center for Cardiovascular Diseases

#### Responsible Party

**Investigator Affiliation:** China National Center for Cardiovascular Diseases

**Investigator Full Name:** Jing Li

**Investigator Title:** JingLi, MD, PhD, professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Coronary Heart Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Xuesaitong Soft Capsule

**Label:** Xuesaitong Soft Capsule

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Each participant in the placebo group will take matching placebo.

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Xuesaitong Soft Capsule

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

**Name:** Xuesaitong Soft Capsule

**Other Names:**

- LixuwangⓇ

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Each participant in the placebo group will take matching placebo.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** hsCRP

**Time Frame:** 12 weeks

#### Secondary Outcomes

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

**Measure:** Other inflammation indicators

**Time Frame:** 12 weeks

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

**Measure:** IPA

**Time Frame:** 12 weeks

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

**Measure:** Vascular endothelial function

**Time Frame:** 12 weeks

**Description:** 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

**Measure:** Blood lipid profiles

**Time Frame:** 12 weeks

**Description:** Changes in Seattle angina scores from baseline at 12 weeks

**Measure:** Seattle Angina Questionnaire

**Time Frame:** 12 weeks

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

**Measure:** SF-36

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jing.li@fwoxford.org

**Name:** Jing Li, MD, PhD

**Phone:** +86 (010) 6086 6077

**Role:** CONTACT

**Contact 2:**

**Email:** liyan@fuwai.com

**Name:** Yan Li, MD

**Phone:** +86 (010) 6086 6795

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** ying.sun@fwoxford.org

- **Name:** Ying Sun, BA

- **Phone:** 18310888612

- **Role:** CONTACT

**Country:** China

**Facility:** Fuwai Hospital, Chinese Academy of Medical Sciences

**State:** Beijing

**Zip:** 100087

#### Overall Officials

**Official 1:**

**Affiliation:** National Center for Cardiovascular Diseases

**Name:** Jing Li, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** National Center for Cardiovascular Diseases

**Name:** Jiamin Liu, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Heart Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Heart Disease

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Heart Disease

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

- ID: D000003327

- Term: Coronary Disease

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

### Misc Info Module

- Version Holder: 2024-05-31
