Status:
COMPLETED
Lipid Lowering in Patients With Statin Intolerance
Lead Sponsor:
Chestnut Hill Health System
Conditions:
Hyperlipidemia
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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 represen...
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 Prog...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00405769
Start Date
January 1 2007
End Date
October 1 2007
Last Update
October 31 2007
Active Locations (1)
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1
Chestnut Hill Hospital
Philadelphia, Pennsylvania, United States, 19118