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

Recruiting Phase 3 Interventional Study
Dyslipidemia Atherosclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
20 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
240 (estimated)
Sponsor
Wenzhou Medical University · Other
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About This Trial
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 a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients with established mild atherosclerotic cardiovascular disease, defined as coronary and/or carotid and/or peripheral artery lesions \<40% lumen diameter stenosis, diagnosed by coronary angiography and carotid and/or peripheral artery ultrasound respectively, together w…
Contacts

Kangting Ji, MD

+8613676403180

jikt@wzmc.edu.cn

CONTACT