NCT06425120

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

Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	Xuesaitong Soft Capsule	Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g.
DRUG	Placebo	Each participant in the placebo group will take matching placebo.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-05-22
• Last updated: 2025-09-08

Locations

2 sites across 1 country: China