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The Effect of Statin Medications on Muscle Performance (The STOMP Study) (STOMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00609063
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : January 9, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Hartford Hospital

Tracking Information
First Submitted Date  ICMJE January 25, 2008
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date January 9, 2012
Study Start Date  ICMJE January 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
  • Myopathy frequency [ Time Frame: Measured every other week ]
  • Arm isokinetic force at 60 degrees per second [ Time Frame: Measured at Month 6 ]
  • Leg isokinetic force at 60 degrees per second [ Time Frame: Measured at Month 6 ]
  • Handgrip isometric force [ Time Frame: Measured at Month 6 ]
  • Leg dynamic endurance [ Time Frame: Measured at Month 6 ]
  • Maximal aerobic power [ Time Frame: Measured at Month 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
  • Structural differences in the muscle samples obtained from symptomatic and asymptomatic participants [ Time Frame: Measured after 2 weeks of symptom persistence ]
  • Skeletal muscle gene expression in muscle samples obtained from symptomatic and asymptomatic participants [ Time Frame: Measured after 2 weeks of symptom persistence ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Statin Medications on Muscle Performance (The STOMP Study)
Official Title  ICMJE The Effect of Statins on Skeletal Muscle Function
Brief Summary Statins are a group of medications that are used to lower cholesterol levels. Although serious side effects are rare, some people taking statins experience muscle pain or weakness. This study will evaluate the number of people who experience mild muscle complaints and will determine the effect of statins on skeletal muscle strength, endurance, and aerobic exercise performance.
Detailed Description

Statins are the most effective medications for reducing high cholesterol levels. They are extremely well tolerated by the majority of people but can produce a variety of muscle-related side effects in some people. Of these side effects, the most serious is rhabdomyolysis, which involves muscle fiber damage that can begin as muscle pain and progress to a loss of muscle cells, kidney failure, and death. While rhabdomyolysis is extremely rare, some people experience the more common muscle-related side effects of statins, such as muscle pain (known as "myalgia"), cramps, and weakness. These more common side effects warrant attention because they may limit the use of statins, affect mobility, and increase the risk of injury in older individuals. Also, the term "muscle weakness," often used by patients and their doctors, is not well defined and can refer to a wide range of complaints from simple fatigue to an actual inability to perform activities of daily living. It is important to describe and quantify in more detail the muscle-related side effects associated with statins. The purpose of this study is to determine the incidence of statin-induced mild muscle complaints and to determine the effect of statins on skeletal muscle strength, endurance, and aerobic exercise performance.

This study will enroll healthy people who have never received statin medications. First, participants will attend three study visits over a period of 2 weeks. These study visits will include blood collection, questionnaires on physical activity and pain, vital sign measurements, and body measurements, including height, weight, and head circumference. Participants will also complete two cardiopulmonary exercise stress tests on a treadmill and will undergo arm and leg strength testing. Some participants may undergo a muscle biopsy. Participants will then be randomly assigned to receive either 80 mg of atorvastatin or placebo on a daily basis for 6 months. Blood will be collected again at Month 3. At Month 6, participants will attend two study visits for repeat baseline measurements. All participants will be contacted by phone every other week during the 6-month treatment period to monitor adverse events and medication compliance.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Muscular Diseases
Intervention  ICMJE
  • Drug: Atorvastatin
    80-mg atorvastatin capsules taken daily for 6 months
    Other Name: Lipitor
  • Drug: Placebo
    Placebo capsules taken daily for 6 months
Study Arms  ICMJE
  • Experimental: 1
    Participants will receive atorvastatin for 6 months.
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: 2
    Participants will receive matching placebo for 6 months.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2012)
420
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2008)
440
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Statin-naive (i.e., has never taken statins before)

Exclusion Criteria:

  • Previous use of statins
  • Current treatment with cholesterol- or triglyceride-lowering drugs
  • Impaired liver or kidney function
  • Untreated hypothyroidism or hyperthyroidism
  • Treatment with other medications known to increase risk of myopathy in atorvastatin-treated patients (e.g., cyclosporine, azithromycin, erythromycin, azole antifungals, fusidic acid)
  • Existing infection requiring treatment with antibiotic therapy
  • Consumption of greater that 1 quart of grapefruit juice per day
  • Documented history of neuroleptic malignant syndrome
  • Inherited muscle disorders or myopathy
  • Known sickle cell trait
  • Cancer within the 5 years prior to study entry
  • Diabetes
  • Currently being treated for high blood pressure
  • Coronary artery disease
  • Peripheral vascular disease
  • Physical disability or previous injury that prevents safe exercise testing
  • Pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00609063
Other Study ID Numbers  ICMJE 552
R01HL081893-01A2 ( U.S. NIH Grant/Contract )
1R01HL081893-01A2 ( U.S. NIH Grant/Contract )
105-0342
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hartford Hospital
Original Responsible Party Paul D. Thompson, MD/Director, Division of Cardiology, Hartford Hospital
Current Study Sponsor  ICMJE Hartford Hospital
Original Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Paul D. Thompson, MD Hartford Hospital
PRS Account Hartford Hospital
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP