Lipid Lowering in Patients With Statin Intolerance - Full Text View

Sponsored by:	Chestnut Hill Health System
Information provided by:	Chestnut Hill Health System
ClinicalTrials.gov Identifier:	NCT00405769

Purpose

This study will attempt to further validate a clinical treatment plan to lower LDL values using non-prescription supplements combined with a lifestyle change and education program which could represent an alternative approach to improve compliance in group of people who are unable to take traditional medication to lower cholesterol.

Condition	Intervention
Hyperlipidemia Coronary Artery Disease	Drug: red yeast rice Drug: placebo

MedlinePlus related topics: Cholesterol Coronary Artery Disease Statins

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Alternative Lipid Lowering in Patients With Statin Intolerance: Use of Red Yeast Rice and Therapeutic Lifestyle Changes in a Randomized, Placebo-Controlled Trial

Further study details as provided by Chestnut Hill Health System:

Primary Outcome Measures:

LDL-cholesterol levels at baseline, 12 weeks and 6 months in 2 groups in a lifestyle intervention program [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

HDL, TG, Total cholesterol, cardiac CRP, [ Time Frame: 24 weeks ]

Enrollment:	64
Study Start Date:	January 2007
Study Completion Date:	October 2007

Arms	Assigned Interventions
1: Placebo Comparator placebo control	Drug: placebo 3 caps bid
2: Active Comparator red yeast rice	Drug: red yeast rice 600 mg 3 caps bid

Detailed Description:

Up to 70 participants will be randomized into 2 groups. Each shall have similar total and LDL cholesterol values obtained prior to the study. Study Group 1 will participate in the Change of Heart Program (an intensive program to make therapeutic lifestyle changes) and take a placebo pill. Study Group 2 will also participate in Change of Heart. Group 2 will be provided an over the counter supplement consisting of red rice yeast 2.4-3.6 gms day)

Blood work consisting of a lipid panel, cardiac CRP, CPK, liver function panel and TSH will be obtained prior to study, and at 12 and 26 wks. Questionnaires will be administered regarding quality of life indexes, and ancillary symptom relief (i.e. degree of arthritis discomfort, generalized weakness) before, 12 and 26 weeks. After the Change of Heart program ends (12 weeks), participants will continue on study medication for a total of 6 months. A final questionnaire and final blood work will be obtained at 6 months, and at that point, medications can be discontinued.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Baseline cholesterol - LDL more than 160 with one risk factor or LDL more than 130 with 2 or more risk factors for developing coronary artery disease (Smoker, age >40, male, Family history, diabetes, obesity) utilizing ATP III guidelines
Have had a statin prescribed by a doctor for high cholesterol, and have stopped medication because of side effects
Ability to exercise without physical restrictions
Ability to attend 12 week consecutive Change of Heart sessions
Not taking any cholesterol lowering medication for at least 1 month prior to initiation of trial. Not taking red yeast rice for at least 1 month prior.

Exclusion Criteria:

Any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year
Known intolerance to one of the study drugs
Physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease
Uncontrolled hypertension (defined as SBP>180 mmHg or DBP > 100mmHg.
Heart attack, bypass surgery, or angioplasty/stent within 1 year of study
Triglyceride level more than 400 mg/dl

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405769

Locations

United States, Pennsylvania
Chestnut Hill Hospital
Philadelphia, Pennsylvania, United States, 19118

Sponsors and Collaborators

Chestnut Hill Health System

Investigators

Principal Investigator:

David J Becker, MD

Chestnut Hill Health System

More Information

Study ID Numbers:	FWA00005390
Study First Received:	November 29, 2006
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00405769
Health Authority:	United States: Institutional Review Board

Keywords provided by Chestnut Hill Health System:

statin intolerance
hyperlipidemia
lifestyle changes
red yeast rice

Study placed in the following topic categories:

Arterial Occlusive Diseases
Hyperlipidemias
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Arteriosclerosis
Coronary Disease
Metabolic disorder
Red yeast rice
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009