Lipid Lowering in Patients With Statin Intolerance

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405769
• Other study ID #: FWA00005390
• Status: Completed
• Phase: N/A
• First received: November 29, 2006
• Last updated: October 30, 2007
• Start date: January 2007
• Est. completion date: October 2007

Study information

• Verified date: October 2007
• Source: Chestnut Hill Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hyperlipidemia
• Hyperlipidemias
• Myocardial Ischemia

Intervention

Drug:
• red yeast rice
600 mg 3 caps bid
• placebo
3 caps bid

Locations

Country	Name	City	State
United States	Chestnut Hill Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Chestnut Hill Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol levels at baseline, 12 weeks and 6 months in 2 groups in a lifestyle intervention program		24 weeks
Secondary	HDL, TG, Total cholesterol, cardiac CRP,		24 weeks