The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin：Comparing With Standardized Statin

NCT02726555 | Recruiting Phase 3 DMC

• 1 other identifier: wzfeyxzk
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia; Atherosclerosis

Keywords

Red yeast rice; Atorvastatin; Mild cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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 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

Other Outcomes (11)

• 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 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

Study Arms (2)

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.

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.

Drug: Atorvastatin alone

Interventions

Red yeast rice and atorvastatin DRUG

Participants will receive 2 capsules of 300mg red yeast rice and 2 capsules of 10mg atorvastatin for 24 weeks.

Also known as: Xuezhikang; Lipitor

Red yeast rice and atorvastatin

Atorvastatin alone DRUG

Participants will receive 2 capsules of placebo and 2 capsules of 10mg atorvastatin for 24 weeks.

Also known as: Lipitor

Atorvastatin alone

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

The Second Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Atherosclerosis

Interventions

red yeast rice; Atorvastatin; xuezhikang

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Kangting Ji, MD

  The Second Hispital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kangting Ji, MD

CONTACT

+8613676403180; jikt@wzmc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 1, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CN (1)