Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-17
Brief Title:
Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
China National Center for Cardiovascular Diseases
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 disease240 eligible patients aged 18 years will be randomized to receive placebo or Xuesaitong Soft Capsules132gd 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 monthsⅠother inflammation indicators except for hsCRP Ⅱ inhibition of platelet aggregation Ⅲendothelial function indicators Ⅳblood lipid levels Ⅴ seattle angina questionnaire score Ⅵ36-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None