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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.
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:(â… )other inflammation indicators except for hsCRP. (â…ˇ) inhibition of platelet aggregation; (â…˘)endothelial function indicators; (â…Ł)blood lipid levels; (â…¤) seattle angina questionnaire score; (â…Ą)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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xuesaitong Soft Capsule | Experimental | Each participant in the Xuesaitong Soft Capsule treatment group will take a daily dose of 1.32g. |
|
| Placebo | Placebo Comparator | Each participant in the placebo group will take matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xuesaitong Soft Capsule | Drug | Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g. |
|
| Measure | Description | Time Frame |
|---|---|---|
| hsCRP | Changes in high-sensitivity C-reactive protein level from baseline at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Other inflammation indicators | Changes in levels of interleukin-6, interleukin-10, interleukin-1β, tumor necrosis factor-α from baseline at 12 weeks | 12 weeks |
| IPA | Changes in level of inhibition of platelet aggregation from baseline at 12 weeks |
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Inclusion Criteria:
Age ≥18 years old
Chronic coronary artery disease: meet any of the following conditions, and the condition is stable for at least 3 months:
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 Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this trial:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Li, MD, PhD | Contact | +86 (010) 6086 6077 | jing.li@fwoxford.org | |
| Yan Li, MD | Contact | +86 (010) 6086 6795 | liyan@fuwai.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Li, MD, PhD | National Center for Cardiovascular Diseases | Principal Investigator |
| Jiamin Liu, MD | National Center for Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100087 | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Placebo | Drug | Each participant in the placebo group will take matching placebo. |
|
| 12 weeks |
| Vascular endothelial function | Changes in intercellular adhesion molecule-1, von Willebrand factor, and endothelin-1 levels from baseline at 12 weeks | 12 weeks |
| 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 |
| Seattle Angina Questionnaire | Changes in Seattle angina scores from baseline at 12 weeks | 12 weeks |
| SF-36 | Changes in Health Survey Scale (SF-36 Scale) scores from baseline at 12 weeks | 12 weeks |
| Affiliated Hospital of Nantong University | Not yet recruiting | Nantong | Jiangsu | China |
|