DyslipidemiaPhase 3NCT02726555
The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin：Comparing With Standardized Statin
A Phase 3 study testing Red yeast rice and atorvastatin and Atorvastatin alone in people with Dyslipidemia and Atherosclerosis, run by Wenzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dyslipidemia, Atherosclerosis
- What is being tested?
- Red yeast rice and atorvastatin and Atorvastatin alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who have met all the above inclusion criteria will be screened for the following exclusion criteria.
- 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.
- Known history of hemorrhagic stroke.
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- Patients with uncontrolled hypertension at the screening visit. Patients on stable antihypertensive medication may be enrolled provided that the medications and dosage remain stable throughout the study.
- Cardiovascular surgery or major operations within 6 months prior to screening visit.
- Patients who are taking anticoagulants except aspirin at < 325 mg/day.
- Patients with liver dysfunction as indicated by a serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) level of > 1.5-times of upper limit of normal (ULN) range, or clinical symptoms.
- Patients with elevated creatine phosphokinase level (above Upper Limit of Normal range).
- Patients with renal dysfunction as indicated by a serum creatinine level above ULN range, or clinical symptoms.
- Patients with gastric or peptic ulcer within 3 months prior to screening visit.
- Patients with medical history of hypothyroidism, pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, or primary biliary cirrhosis. Patients on thyroid replacement therapy at stable doses may be enrolled if clinically euthyroid.
- Patients with clinically relevant illness within 4 weeks prior to screening visit that may interfere with the conduct of this study.
- Patients with a history of alcohol or narcotic substance abuse within two years prior to screening visit.
- Patients with hypersensitivity to lipid-lowering agents.
- Patients who have taken another investigational drug within 4 weeks prior to screening visit.
- Patients with uncontrolled metabolic or endocrine disease knowing to influence lipid values.
- Patients who are known to be HIV positive.
- Patients who have a history or presence of active malignancy (other than non-melanoma skin cancer) or clinically significant psychiatric, neurological, respiratory, hematological, or other conditions that in the opinion of investigators might interfere with or contraindicate participation of the patients in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Kangting Ji, MD, +8613676403180, jikt@wzmc.edu.cn
About this study
Official title: Comparison Between Combined Therapy With Red Yeast Rice and Low-dose Statin and Standardized Statin: a Single-center, Non-inferiority, Randomized Clinical 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.
Read the detailed description
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.
- Conditions
- Dyslipidemia, Atherosclerosis
- Being tested
- Red yeast rice and atorvastatin, Atorvastatin alone
- Keywords
- Red yeast rice, Atorvastatin, Mild cardiovascular disease
- Medical subject headings
- Dyslipidemias, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red yeast rice and atorvastatinDrug
Also called Xuezhikang; Lipitor
Participants will receive 2 capsules of 300mg red yeast rice and 2 capsules of 10mg atorvastatin for 24 weeks.
Atorvastatin aloneDrug
Also called Lipitor
Participants will receive 2 capsules of placebo and 2 capsules of 10mg atorvastatin for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Red yeast rice and atorvastatin | Experimental | Participants will receive 4 identically appearing capsules twice daily for 24 weeks: 2 300mg of red yeast rice and 2 10mg of atorvastatin. Receives: Drug: Red yeast rice and atorvastatin |
| Atorvastatin alone | Active comparator | Participants will receive 4 identically appearing capsules twice daily for 24 weeks: 2 placebo and 2 10mg of atorvastatin. Receives: Drug: Atorvastatin alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percentage change from baseline at week 24 (or the last assessment) on serum low-density lipoprotein cholesterol (LDL-C) level
Measured: Measured at screening, baseline, week 4, week 8, week 16, and week 24
Secondary outcomes (5)
Mean percentage change from baseline at week 24 (or the last assessment on serum total cholesterol (TC) level
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Measured at week 4, week 8, week 16, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kangting Ji, MD, Wenzhou Medical University
- Investigators
- Kangting Ji, MD, Principal investigator, The Second Hispital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726555
- Sponsor's protocol ID
- wzfeyxzk
- Status last verified
- Aug 2024
- First submitted
- 29 Mar 2016
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Combined Therapy With Red Yeast Rice and Low-dose Statin and Standardized Statin: a Single-center, Non-inferiority, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02726555
- Acronym / sponsor ID
- wzfeyxzk
- Conditions
- Dyslipidemia, Atherosclerosis
- Keywords
- Red yeast rice, Atorvastatin, Mild cardiovascular disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red yeast rice and atorvastatin | Experimental | Drug: Red yeast rice and atorvastatinParticipants will receive 4 identically appearing capsules twice daily for 24 weeks: 2 300mg of red yeast rice and 2 10mg of atorvastatin. |
| Atorvastatin alone | Active comparator | Drug: Atorvastatin aloneParticipants will receive 4 identically appearing capsules twice daily for 24 weeks: 2 placebo and 2 10mg of atorvastatin. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- Patients who have met all the above inclusion criteria will be screened for the following exclusion criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red yeast rice and atorvastatinAlso: Xuezhikang; LipitorParticipants will receive 2 capsules of 300mg red yeast rice and 2 capsules of 10mg atorvastatin for 24 weeks. | Drug | Red yeast rice and atorvastatin |
| Atorvastatin aloneAlso: LipitorParticipants will receive 2 capsules of placebo and 2 capsules of 10mg atorvastatin for 24 weeks. | Drug | Atorvastatin alone |
Primary outcome
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
5 secondary outcomes
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)
Time frame: Measured at week 4, week 8, week 16, and week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kangting Ji, MD principal investigator
The Second Hispital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Red yeast rice and atorvastatin and Atorvastatin alone in people with Dyslipidemia and Atherosclerosis, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kangting Ji, MD (+8613676403180, jikt@wzmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.