Muscle Characteristics Associated With Statin Therapy

May 21, 2015 updated by: Scripps Health
The purpose of this study is to investigate the mechanism of statin-related myopathy by evaluating muscle samples before and after statin exposure.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Scripps-Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Statin exposure
Subjects' endpoints will be measured before and after one to eight months of statin exposure.
Drug: simvastatin
simvastatin 80 mg PO daily for one to eight months.
Other Names:
  • Zocor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrogin-1 expression.
Time Frame: One to eight months.
One to eight months.
Intramuscular Ras level.
Time Frame: One to eight months.
One to eight months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Intramuscular Coenzyme Q10 level.
Time Frame: One to eight months.
One to eight months.
Intramuscular mitochondrial to nuclear DNA ratio.
Time Frame: One to eight months.
One to eight months.
Intramuscular geranylgeranylpyrophosphate.
Time Frame: One to eight months.
One to eight months.
PPAR-gamma coactivator-1-alpha expression.
Time Frame: One to eight months.
One to eight months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Health

Investigators

  • Principal Investigator: Paul S Phillips, MD, Scripps Health
  • Principal Investigator: Tam H Truong, MD, Scripps Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (Estimate)

October 7, 2009

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCAST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myopathy

Clinical Trials on simvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe