A Phase 3 interventional study of Red yeast rice and atorvastatin and Atorvastatin alone in Dyslipidemia and Atherosclerosis, sponsored by Wenzhou Medical University. Recruiting at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Wenzhou Medical University · Phase 3, Interventional, and Treatment
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.
Both Red Yeast Rice and Statins are cholesterol-lowering medications are often prescribed for secondary prevention of cardiovascular disease (CVD). 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 aim of this study is to compare the efficacy and safety of combined therapy with red yeast rice at 1.2 g/day and atorvastatin at 10 mg/day with atorvastatin at 20 mg/day in persons with mild atherosclerotic cardiovascular disease and who qualified for statin therapy according to national guidelines.
This study will enroll individuals with established mild atherosclerotic cardiovascular disease and who do not currently take lipid-lowering medications. Participants will be randomly assigned to receive combined therapy with red yeast rice at 1.2 g/day and atorvastatin at 10 mg/day or atorvastatin at 20 mg/day for 24 weeks. Study visits will occur at screening, baseline, week 4, week 8, week 16, and week 24. Blood will be collected for laboratory testing, and standardized questionnaires will assess noncardiovascular endpoints. Pill count will be used to assess adherence of treatment. Medication side effects will be monitored and tests of alanine aminotransferase (ALT), aspartate aminotransaminase (AST) and creatine phosphate kinase (CPK) will be performed. Medication efficacy will be assessed and test of low-density lipoprotein cholesterol (LDL-C) will be performed.
1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.
This study's planned enrollment of 240 is above the median of 100 across 986 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Wenzhou Medical University is the lead sponsor of 94 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who have met all the above inclusion criteria will be screened for the following exclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 4 identically appearing capsules twice daily for 24 weeks: 2 300mg of red yeast rice and 2 10mg of atorvastatin.
Drug: Red yeast rice and atorvastatin
Participants will receive 4 identically appearing capsules twice daily for 24 weeks: 2 placebo and 2 10mg of atorvastatin.
Drug: Atorvastatin alone
Drug pages: Red yeast rice · Atorvastatin
Participants will receive 2 capsules of 300mg red yeast rice and 2 capsules of 10mg atorvastatin for 24 weeks.
Also known as: Xuezhikang; Lipitor
Participants will receive 2 capsules of placebo and 2 capsules of 10mg atorvastatin for 24 weeks.
Also known as: Lipitor
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 24
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 24
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 24
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 24
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 24
Percentage of Participants Who Experienced Statin-associated muscle symptoms (SAMs)
SAMs included all muscle-related complaints (e.g. pain, weakness, or cramps). Reported events are muscle-related complaints confirmed by an independent Clinical Events Committee (CEC) according to the nature of the muscle symptoms, the elevation in creatine kinase (CK) levels and their temporal association with statin initiation, discontinuation, and re-challenge.
Time frame: Measured at week 4, week 8, week 16, and week 24
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 24
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 24
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 24
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 24
Mean percentage change from baseline at week 24 (or the last assessment) on Memory problems score
Memory problems 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 24
Mean percentage change from baseline at week 24 (or the last assessment) on Attention/concentration problems score
Attention/concentration problems 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 24
Mean percentage change from baseline at week 24 (or the last assessment) on Calculation problems score
Calculation problems 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 24
Mean percentage change from baseline at week 24 (or the last assessment) on Depression/hopelessness score
Depression/hopelessness 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 24
Mean percentage change from baseline at week 24 (or the last assessment) on Anxiety score
Anxiety included restless, impatience, irritability, nervous, anxious. Anxiety 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 24
Mean percentage change from baseline at week 24 (or the last assessment) on Sleep problems score
Sleep problems 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 24
Safety will be assessed by the incidence of adverse events (AEs), discontinuation due to the AEs, clinically relevant changes on laboratory test results, vital signs, physical examinations, and 12-lead electrocardiograms (ECG).
ECG and Physical exam only at Screening and Week 24
Time frame: Screening, Baseline, Week 4, Week 8, week 16, and week 24
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2015 (actual). Primary completion is estimated for May 2026, 126 months after the start.
Of 62 phase 3 interventional studies under Dyslipidemias, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 126 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Red yeast rice · Atorvastatin
Wenzhou Medical University