Suspended

Muscle Characteristics Associated With Statin Therapy

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What is being tested

simvastatin

Drug
Who is being recruted

Muscular Diseases+1

+ Musculoskeletal Diseases

+ Nervous System Diseases

From 21 to 90 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: November 2009
See protocol details

Summary

Principal SponsorScripps Health
Last updated: January 27, 2026
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Study start date: November 1, 2009

Actual date on which the first participant was enrolled.

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 rhabdomyolysis are rare but myalgia is commonly noted in clinical practice. The pathophysiology of these events remains obscure. Previous studies suggest that statins block the downstream products (such as cellular signaling molecules) of the mevalonate pathway needed for normal muscle function. Other studies show that statins are associated with gene expressions involved in muscle damage such as atrogin-1. We will quantify these entities pre and post statin therapy to better understand these reactions.

Official TitleMuscle Characteristics Associated With Statin Therapy
Principal SponsorScripps Health
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Muscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeuromuscular Diseases

Criteria

7 inclusion criteria required to participate
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.

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6 exclusion criteria prevent from participating
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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects' endpoints will be measured before and after one to eight months of statin exposure.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Scripps-Mercy Hospital

San Diego, United StatesOpen Scripps-Mercy Hospital in Google Maps
SuspendedOne Study Center