The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin：Comparing With Standardized Statin
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-80
SponsorWenzhou Medical University
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 with LDL cholesterol level > 70 mg/dL (1.80 mmol/L).
Female patients must be postmenopausal as defined by no menstruation for at least 12 months, or surgically sterilized for at least three months prior to beginning the study, or have a negative pregnancy test and agree to avoid pregnancy during the study and one month after the end of the study by using two reliable methods of contraception.
Patients must have been informed of all aspects of the study and signed an informed consent form before any study-related activities.
Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Disqualifiers
Patients who have been taken lipid-lowering medications including statins or red yeast rice products during the 4 weeks prior to the screening visit.
Documented history of myocardial infarction (MI), unstable angina leading to hospitalization, uncontrolled cardiac arrhythmia, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), carotid surgery or stenting, cerebrovascular accident, transient ischemic attack, endovascular procedure or surgical intervention for peripheral vascular disease.
Planned to undergo scheduled PCI, CABG, carotid or peripheral revascularization during the study.
History of New York Heart Association Class III or IV heart failure within the past 12 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Red yeast rice and atorvastatin
DrugParticipants will receive 2 capsules of 300mg red yeast rice and 2 capsules of 10mg atorvastatin for 24 weeks.
Atorvastatin alone
DrugParticipants will receive 2 capsules of placebo and 2 capsules of 10mg atorvastatin for 24 weeks.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Red yeast rice and atorvastatinExperimental treatment 1 intervention
Group B: Atorvastatin aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean percentage change from baseline at week 24 (or the last assessment) on serum low-density lipoprotein cholesterol (LDL-C) level
Time frame
Measured at screening, baseline, week 4, week 8, week 16, and week 24Secondary outcomes
1
Mean percentage change from baseline at week 24 (or the last assessment on serum total cholesterol (TC) level
Time frame
Measured at screening, baseline, week 4, week 8, week 16, and week 242
Mean percentage change from baseline at week 24 (or the last assessment) on serum high-density lipoprotein cholesterol (HDL-C) level
Time frame
Measured at screening, baseline, week 4, week 8, week 16, and week 243
Mean percentage change from baseline at week 24 (or the last assessment) on serum triglyceride (TG) level
Time frame
Measured at screening, baseline, week 4, week 8, week 16, and week 244
Mean percentage change from baseline at week 24 (or the last assessment) on serum non-HDL cholesterol level
Time frame
Measured at screening, baseline, week 4, week 8, week 16, and week 24Other outcomes
1
Mean percentage change from baseline at week 24 (or the last assessment) on serum fasting blood glucose level
Time frame
Measured at baseline, week 4, week 8, week 16, and week 242
Mean percentage change from baseline at week 24 (or the last assessment) on serum glycosylated hemoglobin level
Time frame
Measured at baseline, week 4, week 8, week 16, and week 243
Mean percentage change from baseline at week 24 (or the last assessment) on Physical Activity Level
Physical activity level will be estimated by short version of international physical activity questionnaire (IPAQ).
Time frame
Measured at baseline, week 4, week 8, week 16, and week 244
Mean percentage change from baseline at week 24 (or the last assessment) on fatigue scores
Fatigue score is self-rated, ranging from 0-10. For the severity scale, 0=not present, 10=most severe.
Time frame
Measured at baseline, week 4, week 8, week 16, and week 24Sponsors and contacts
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Source ClinicalTrials.gov