Trials Sponsors Conditions Drugs Pricing

Conditions

Dyslipidemia Atherosclerosis

Keywords

Red yeast riceAtorvastatinMild 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
+8 more other outcomes

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 atorvastatinDrug

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 aloneDrug

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

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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).

Sponsors & Collaborators

Wenzhou Medical University
Otherlead

Study Sites (1)

The Second Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Kangting Ji, MDCONTACT+8613676403180 jikt@wzmc.edu.cn

MeSH Terms

Conditions

DyslipidemiasAtherosclerosis

Interventions

red yeast riceAtorvastatinxuezhikang

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles

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 2015

Actual (reported)

Primary Completion

May 2026

Estimated (date passed)

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.
+5 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (11)

Study Arms (2)

Red yeast rice and atorvastatin

Atorvastatin alone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (11)

Study Arms (2)

Red yeast rice and atorvastatin

Atorvastatin alone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations