Lipid Lowering in Patients With Statin Intolerance

This study has been completed.
Sponsor:
Information provided by:
Chestnut Hill Health System
ClinicalTrials.gov Identifier:
NCT00405769
First received: November 29, 2006
Last updated: October 30, 2007
Last verified: October 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
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

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:

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

No publications provided by Chestnut Hill Health System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00405769     History of Changes
Other Study ID Numbers: FWA00005390
Study First Received: November 29, 2006
Last Updated: October 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Chestnut Hill Health System:
statin intolerance
hyperlipidemia
lifestyle changes
red yeast rice

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Hyperlipidemias
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Dyslipidemias
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Red yeast rice
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014