Actively Recruiting
The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin：Comparing With Standardized Statin
Led by Wenzhou Medical University · Updated on 2024-08-06
240
Participants Needed
1
Research Sites
547 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin：Comparing With Standardized Statin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established mild atherosclerotic cardiovascular disease with less than 40% artery blockage diagnosed by imaging, and LDL cholesterol level above 70 mg/dL
- Female participants must be postmenopausal, surgically sterilized for at least 3 months, or have a negative pregnancy test and agree to avoid pregnancy using two reliable contraception methods during and one month after the study
- Signed informed consent after being informed about the study
- Willing and able to follow scheduled visits, treatment plans, lab tests, and study procedures
You will not qualify if you...
- Use of lipid-lowering medications including statins or red yeast rice products within 4 weeks before screening
- History of heart attack, unstable angina requiring hospitalization, uncontrolled heart rhythm problems, certain heart surgeries or procedures, stroke, or vascular surgeries
- Planned heart or artery procedures during the study
- Severe heart failure within the past 12 months
- History of bleeding stroke
- Uncontrolled high blood pressure at screening (stable blood pressure medication allowed if unchanged during study)
- Major surgery within 6 months before screening
- Use of anticoagulants other than aspirin at less than 325 mg/day
- Liver dysfunction indicated by high liver enzyme levels or symptoms
- Elevated muscle enzyme levels
- Kidney dysfunction indicated by high creatinine levels or symptoms
- Recent stomach or peptic ulcers within 3 months before screening
- History of certain medical conditions including hypothyroidism, pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, or primary biliary cirrhosis (stable thyroid treatment allowed)
- Significant illness within 4 weeks before screening that might affect study participation
- History of alcohol or drug abuse within 2 years before screening
- Allergy to lipid-lowering drugs
- Use of other investigational drugs within 4 weeks before screening
- Uncontrolled metabolic or endocrine diseases affecting lipid levels
- Known HIV positive status
- History or presence of active cancer (except certain skin cancers) or serious psychiatric, neurological, respiratory, blood, or other conditions that could interfere with study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
K
Kangting Ji, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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