Status:
WITHDRAWN
Muscle Characteristics Associated With Statin Therapy
Lead Sponsor:
Scripps Health
Conditions:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Myopathy
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the mechanism of statin-related myopathy by evaluating muscle samples before and after statin exposure.
Detailed Description
Statins have been proven to reduce cardiovascular events and mortality in large clinical trials but remain underutilized partly due to the associated myopathy. Severe reactions manifested as rhabdomyo...
Eligibility Criteria
Inclusion
- Primary surgeon's permission.
- Patient is \> 21 years of age.
- Patient will go through a two phase surgery with the two procedures one to eight months apart.
- Patient or representative understands the nature of the study.
- Normal thyroid stimulating hormone (TSH).
- LDL-cholesterol \> 100 mg/dL or highly sensitive C-reactive protein (hsCRP) \> 2.0.
- One of the following risk factors: male \> 45 year old or female \> 55 year old, smoker, hypertension, first degree family history of coronary artery disease \< 55 year old, HDL \<40 mg/dL, chronic kidney disease, diabetes mellitus, previous TIA or stroke, previous coronary artery disease.
Exclusion
- Has been on a lipid-lowering medication previously.
- Severe illness (e.g. trauma or sepsis) more than 24 hours before obtaining the first biopsy.
- Less than a 10% reduction of LDL after 3 months of therapy (indicative of non-adherence).
- Contraindications to statins such as liver failure.
- History of underlying muscle disorder.
- Taking amiodarone.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00990834
Start Date
November 1 2009
End Date
June 1 2011
Last Update
May 22 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Scripps-Mercy Hospital
San Diego, California, United States, 92103