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Lipid Lowering in Patients With Statin Intolerance

Primary Purpose

Hyperlipidemia, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
red yeast rice
placebo
Sponsored by
Chestnut Hill Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemia focused on measuring statin intolerance, hyperlipidemia, lifestyle changes, red yeast rice

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chestnut Hill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

placebo control

red yeast rice

Outcomes

Primary Outcome Measures

LDL-cholesterol levels at baseline, 12 weeks and 6 months in 2 groups in a lifestyle intervention program

Secondary Outcome Measures

HDL, TG, Total cholesterol, cardiac CRP,

Full Information

First Posted
November 29, 2006
Last Updated
October 30, 2007
Sponsor
Chestnut Hill Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00405769
Brief Title
Lipid Lowering in Patients With Statin Intolerance
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 Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chestnut Hill Health System

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Coronary Artery Disease
Keywords
statin intolerance, hyperlipidemia, lifestyle changes, red yeast rice

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo control
Arm Title
2
Arm Type
Active Comparator
Arm Description
red yeast rice
Intervention Type
Drug
Intervention Name(s)
red yeast rice
Intervention Description
600 mg 3 caps bid
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
3 caps bid
Primary Outcome Measure Information:
Title
LDL-cholesterol levels at baseline, 12 weeks and 6 months in 2 groups in a lifestyle intervention program
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
HDL, TG, Total cholesterol, cardiac CRP,
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Becker, MD
Organizational Affiliation
Chestnut Hill Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chestnut Hill Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19528562
Citation
Becker DJ, Gordon RY, Halbert SC, French B, Morris PB, Rader DJ. Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial. Ann Intern Med. 2009 Jun 16;150(12):830-9, W147-9. doi: 10.7326/0003-4819-150-12-200906160-00006.
Results Reference
derived

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Lipid Lowering in Patients With Statin Intolerance

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