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Hydroxymethylglutaryl-CoA Reductase InhibitorsSTOMPNCT00609063

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

A study testing Atorvastatin in people with Hydroxymethylglutaryl-CoA Reductase Inhibitors and Muscular Diseases, run by Hartford Hospital at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
What is being tested?
Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
3 sitesUnited States
Study dates
Jan 2008to Jun 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Massachusetts

    Amherst, Massachusetts, 01003

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • University of Connecticut

    Storrs, Connecticut, 06269

Other trials in United States

About this study

Official title: The Effect of Statins on Skeletal Muscle Function

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.

Read the 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.

Being tested
Atorvastatin, Placebo
Keywords
Statins, Myalgia, Muscle Cramp
Medical subject headings
Muscular Diseases, Myalgia, Muscle Cramp

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Also called Lipitor

    80-mg atorvastatin capsules taken daily for 6 months

  • PlaceboDrug

    Placebo capsules taken daily for 6 months

Study groups in NCT00609063
Study groupRoleWhat they receive
1ExperimentalParticipants will receive atorvastatin for 6 months.
Receives: Drug: Atorvastatin
2Placebo comparatorParticipants will receive matching placebo for 6 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myopathy frequency

    Measured: Measured every other week

  2. Arm isokinetic force at 60 degrees per second

    Measured: Measured at Month 6

  3. Leg isokinetic force at 60 degrees per second

    Measured: Measured at Month 6

  4. Handgrip isometric force

    Measured: Measured at Month 6

  5. Leg dynamic endurance

    Measured: Measured at Month 6

  6. Maximal aerobic power

    Measured: Measured at Month 6

Secondary outcomes (2)

  1. Structural differences in the muscle samples obtained from symptomatic and asymptomatic participants

    Measured: Measured after 2 weeks of symptom persistence

  2. Skeletal muscle gene expression in muscle samples obtained from symptomatic and asymptomatic participants

    Measured: Measured after 2 weeks of symptom persistence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00609063
Sponsor's protocol ID
552
Other IDs
R01HL081893-01A2, 1R01HL081893-01A2, 105-0342
Acronym
STOMP
Status last verified
Jan 2012
First submitted
25 Jan 2008
Last updated
9 Jan 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Taylor BA, Dager AD, Panza GA, Zaleski AL, Meda S, Book G, Stevens MC, Tartar S, White CM, Polk DM, Pearlson GD, Thompson PD. The effect of high-dose atorvastatin on neural activity and cognitive function. Am Heart J. 2018 Mar;197:166-174. doi: 10.1016/j.ahj.2017.10.027. Epub 2017 Dec 6.

    PubMed 29447778

  • Ballard KD, Taylor BA, Capizzi JA, Grimaldi AS, White CM, Thompson PD. Atorvastatin Treatment Does Not Alter Pulse Wave Velocity in Healthy Adults. Int Sch Res Notices. 2014 Nov 13;2014:239575. doi: 10.1155/2014/239575. eCollection 2014.

    PubMed 27351006

  • Ballard KD, Parker BA, Capizzi JA, Grimaldi AS, Clarkson PM, Cole SM, Keadle J, Chipkin S, Pescatello LS, Simpson K, White CM, Thompson PD. Increases in creatine kinase with atorvastatin treatment are not associated with decreases in muscular performance. Atherosclerosis. 2013 Sep;230(1):121-4. doi: 10.1016/j.atherosclerosis.2013.07.001. Epub 2013 Jul 13.

    PubMed 23958263

  • Parker BA, Capizzi JA, Grimaldi AS, Clarkson PM, Cole SM, Keadle J, Chipkin S, Pescatello LS, Simpson K, White CM, Thompson PD. Effect of statins on skeletal muscle function. Circulation. 2013 Jan 1;127(1):96-103. doi: 10.1161/CIRCULATIONAHA.112.136101. Epub 2012 Nov 26.

    PubMed 23183941

  • Parker BA, Capizzi JA, Augeri AL, Grimaldi AS, Michael White C, Thompson PD. Atorvastatin increases exercise leg blood flow in healthy adults. Atherosclerosis. 2011 Dec;219(2):768-73. doi: 10.1016/j.atherosclerosis.2011.09.049. Epub 2011 Oct 4.

    PubMed 22018642

Questions about this trial

What is this clinical trial studying?

A study testing Atorvastatin in people with Hydroxymethylglutaryl-CoA Reductase Inhibitors and Muscular Diseases, run by Hartford Hospital at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myopathy frequency (time frame: Measured every other week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00609063, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2012.

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