Lipid Lowering in Patients With Statin Intolerance

Not Applicable

Completed

• Conditions: Hyperlipidemia; Coronary Artery Disease
• Interventions: Drug: placebo; Drug: red yeast rice

• Registration Number: NCT00405769
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-11-30
• Study Start: 2007-01
• Status Verified: 2007-10
• Study Completion: 2007-10
• Last Update Submitted: 2007-10-30
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	placebo	placebo control
2	red yeast rice	red yeast rice

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol levels at baseline, 12 weeks and 6 months in 2 groups in a lifestyle intervention program	24 weeks

Secondary Outcome Measures

Name	Time	Method
HDL, TG, Total cholesterol, cardiac CRP,	24 weeks

Trial Locations

Locations (1)

Chestnut Hill Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States