Muscle Characteristics Associated With Statin Therapy

Withdrawn before enrolling · Not applicable

Conditions studied: Hydroxymethylglutaryl-CoA Reductase Inhibitors, Myopathy

In brief

The purpose of this study is to investigate the mechanism of statin-related myopathy by evaluating muscle samples before and after statin exposure.

Key facts

Study ID

NCT00990834

Run by

Scripps Health

People needed

0

Starts

2009-11-01

Expected to finish

2011-06-01

Last updated by the study team

2015-05-22

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Scripps-Mercy Hospital — San Diego, California, United States

Full record on ClinicalTrials.gov

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