Clinical Trial

The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin：Comparing With Standardized Statin

Recruiting Phase 3
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Record status
This record was last updated August 6, 2024 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
Double-dose statin regimen achieves merely 6% of decrease in low-density lipoprotein cholesterol (LDL-C) levels, whereas the risk of side effects increased largely. The investigators' previous pilot study (NCT01686451) has suggested that red yeast rice was of similar lipid-lowering efficacy while was associated with less fatigue than statins. The purpose of this study is to evaluate the efficacy and safety of combined therapy with red yeast rice and low-dose atorvastatin in persons with mild atherosclerotic cardiovascular disease and who qualified for statin therapy according to national guidelines.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2016-03-29; most recent amendment 2024-08-04.
Trial Details
NCT Number NCT02726555
Lead Sponsor Wenzhou Medical University
Conditions Dyslipidemia, Atherosclerosis
Enrollment 240 participants
Start Date 2015-11
Primary Completion 2026-05 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2024-08-06