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Lipid Lowering in Patients With Statin Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00405769
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : October 31, 2007
Information provided by:
Chestnut Hill Health System

Brief Summary:
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 or disease Intervention/treatment Phase
Hyperlipidemia Coronary Artery Disease Drug: red yeast rice Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : January 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
placebo control
Drug: placebo
3 caps bid

Active Comparator: 2
red yeast rice
Drug: red yeast rice
600 mg 3 caps bid

Primary Outcome Measures :
  1. 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 :
  1. HDL, TG, Total cholesterol, cardiac CRP, [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. 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
  2. Have had a statin prescribed by a doctor for high cholesterol, and have stopped medication because of side effects
  3. Ability to exercise without physical restrictions
  4. Ability to attend 12 week consecutive Change of Heart sessions
  5. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00405769

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United States, Pennsylvania
Chestnut Hill Hospital
Philadelphia, Pennsylvania, United States, 19118
Sponsors and Collaborators
Chestnut Hill Health System
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Principal Investigator: David J Becker, MD Chestnut Hill Health System

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00405769    
Other Study ID Numbers: FWA00005390
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by Chestnut Hill Health System:
statin intolerance
lifestyle changes
red yeast rice
Additional relevant MeSH terms:
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Red yeast rice
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents