The Effect of Statin Medications on Muscle Performance (The STOMP Study)
STOMP
The Effect of Statins on Skeletal Muscle Function
4 other identifiers
interventional
420
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 25, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJanuary 9, 2012
January 1, 2012
3.4 years
January 25, 2008
January 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Myopathy frequency
Measured every other week
Arm isokinetic force at 60 degrees per second
Measured at Month 6
Leg isokinetic force at 60 degrees per second
Measured at Month 6
Handgrip isometric force
Measured at Month 6
Leg dynamic endurance
Measured at Month 6
Maximal aerobic power
Measured at Month 6
Secondary Outcomes (2)
Structural differences in the muscle samples obtained from symptomatic and asymptomatic participants
Measured after 2 weeks of symptom persistence
Skeletal muscle gene expression in muscle samples obtained from symptomatic and asymptomatic participants
Measured after 2 weeks of symptom persistence
Study Arms (2)
1
EXPERIMENTALParticipants will receive atorvastatin for 6 months.
2
PLACEBO COMPARATORParticipants will receive matching placebo for 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- Statin-naive (i.e., has never taken statins before)
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hartford Hospital
Hartford, Connecticut, 06102, United States
University of Connecticut
Storrs, Connecticut, 06269, United States
University of Massachusetts
Amherst, Massachusetts, 01003, United States
Related Publications (5)
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.
PMID: 29447778DERIVEDBallard 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.
PMID: 27351006DERIVEDBallard 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.
PMID: 23958263DERIVEDParker 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.
PMID: 23183941DERIVEDParker 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.
PMID: 22018642DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul D. Thompson, MD
Hartford Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2008
First Posted
February 6, 2008
Study Start
January 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
January 9, 2012
Record last verified: 2012-01