The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin：Comparing Wit… (NCT02726555) | Clinical Trial Compass
RecruitingPhase 3
The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin：Comparing With Standardized Statin
China240 participantsStarted 2015-11
Plain-language 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.
Who can participate
Age range20 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
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.
What they're measuring
1
Mean percentage change from baseline at week 24 (or the last assessment) on serum low-density lipoprotein cholesterol (LDL-C) level
Timeframe: Measured at screening, baseline, week 4, week 8, week 16, and week 24
✕. 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.
✕. 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.