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:(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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
240
Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g.
Each participant in the placebo group will take matching placebo.
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGAffiliated Hospital of Nantong University
Nantong, Jiangsu, China
NOT_YET_RECRUITINGhsCRP
Changes in high-sensitivity C-reactive protein level from baseline at 12 weeks
Time frame: 12 weeks
Other inflammation indicators
Changes in levels of interleukin-6, interleukin-10, interleukin-1β, tumor necrosis factor-α from baseline at 12 weeks
Time frame: 12 weeks
IPA
Changes in level of inhibition of platelet aggregation from baseline at 12 weeks
Time frame: 12 weeks
Vascular endothelial function
Changes in intercellular adhesion molecule-1, von Willebrand factor, and endothelin-1 levels from baseline at 12 weeks
Time frame: 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
Time frame: 12 weeks
Seattle Angina Questionnaire
Changes in Seattle angina scores from baseline at 12 weeks
Time frame: 12 weeks
SF-36
Changes in Health Survey Scale (SF-36 Scale) scores from baseline at 12 weeks
Time frame: 12 weeks
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