Atherosclerosis, Dyslipidemia
Conditions
Keywords
Red yeast rice, Atorvastatin, Mild cardiovascular disease
Brief 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 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.
Interventions
DRUGRed yeast rice and atorvastatin
Participants will receive 2 capsules of 300mg red yeast rice and 2 capsules of 10mg atorvastatin for 24 weeks.
DRUGAtorvastatin alone
Participants will receive 2 capsules of placebo and 2 capsules of 10mg atorvastatin for 24 weeks.
Sponsors
Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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 with LDL cholesterol level \> 70 mg/dL (1.80 mmol/L). 2. 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. 3. Patients must have been informed of all aspects of the study and signed an informed consent form before any study-related activities. 4. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Patients who have met all the above inclusion criteria will be screened for the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change from baseline at week 24 (or the last assessment) on serum low-density lipoprotein cholesterol (LDL-C) level | Measured at screening, baseline, week 4, week 8, week 16, and week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean percentage change from baseline at week 24 (or the last assessment) on serum high-density lipoprotein cholesterol (HDL-C) level | 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 | 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 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 at screening, baseline, week 4, week 8, week 16, and week 24 | — |
| Percentage of Participants Who Experienced Statin-associated muscle symptoms (SAMs) | Measured at week 4, week 8, week 16, and week 24 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean percentage change from baseline at week 24 (or the last assessment) on Calculation problems score | Measured at baseline, week 4, week 8, week 16, and week 24 | Calculation problems score is self-rated, ranging from 0-10. For the severity scale, 0=not present, 10=most severe. |
| Mean percentage change from baseline at week 24 (or the last assessment) on Depression/hopelessness score | Measured at baseline, week 4, week 8, week 16, and week 24 | Depression/hopelessness score is self-rated, ranging from 0-10. For the severity scale, 0=not present, 10=most severe. |
| Mean percentage change from baseline at week 24 (or the last assessment) on serum fasting blood glucose level | 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 | Measured at baseline, week 4, week 8, week 16, and week 24 | Sleep problems score is self-rated, ranging from 0-10. For the severity scale, 0=not present, 10=most severe. |
| 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). | Screening, Baseline, Week 4, Week 8, week 16, and week 24 | ECG and Physical exam only at Screening and Week 24 |
| Mean percentage change from baseline at week 24 (or the last assessment) on Anxiety score | Measured at baseline, week 4, week 8, week 16, and week 24 | 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. |
| Mean percentage change from baseline at week 24 (or the last assessment) on serum glycosylated hemoglobin level | 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 | Measured at baseline, week 4, week 8, week 16, and week 24 | Physical activity level will be estimated by short version of international physical activity questionnaire (IPAQ). |
| Mean percentage change from baseline at week 24 (or the last assessment) on fatigue scores | Measured at baseline, week 4, week 8, week 16, and week 24 | Fatigue score is self-rated, ranging from 0-10. For the severity scale, 0=not present, 10=most severe. |
| Mean percentage change from baseline at week 24 (or the last assessment) on Memory problems score | Measured at baseline, week 4, week 8, week 16, and week 24 | Memory problems score is self-rated, ranging from 0-10. For the severity scale, 0=not present, 10=most severe. |
| Mean percentage change from baseline at week 24 (or the last assessment) on Attention/concentration problems score | Measured at baseline, week 4, week 8, week 16, and week 24 | Attention/concentration problems score is self-rated, ranging from 0-10. For the severity scale, 0=not present, 10=most severe. |
Countries
China
Contacts
Primary ContactKangting Ji, MD
Outcome results
None listed