7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adver… (NCT04507373) | Clinical Trial Compass
TerminatedPhase 4
7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events
Stopped: No grant obtained. Enrolled participants were not assigned to the intervention and was study terminated
United States3 participantsStarted 2018-08-17
Plain-language summary
Over 40 million Americans take statins to reduce their risk of atherosclerotic cardiovascular disease (ASCVD). Unfortunately, 10 to 20% stop taking them due to statin-associated muscle symptoms (e.g. pain, aches, weakness, cramps, or stiffness) (1, 2). The pathophysiology of these statin-associated muscle symptoms (SAMS) has remained elusive. Consequently, no objective diagnostic method exists, causing confusion for patient and providers since muscle symptoms can often be multifactorial.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion
• Adults, age \> 18 ys or \< 80 yrs. Patients reporting complaints of statin-associated muscle symptoms, aches, weakness, cramps, or stiffness in the legs.
Exclusion Criteria
* Patient who drink large quantities of grapefruit juice (\> 1 quart daily).
* Patients on the following drugs for which the FDA has issued restrictions for using simvastatin 40 mg daily do to an increased risk of severe muscle injury such as itraconazole, posaconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV-1 protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, amlodipine, ranolazine, and verapamil.
* Patients with muscle-related pain that is not related to statin-use (e.g. muscle aches from strain or trauma) or remains unexplained.
* Any patients with underlying non-statin related muscle disorders.
* Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins.
* Conditions of severe acute vascular stress (acute coronary syndrome, ischemic stroke, or major vascular surgery) within prior 3 months.
* Any patients with a history of severe or life-threatening reactions to statins including rhabdomyolysis (defined as evidence of organ damage with CK \>10,000 IU/L), CK elevation \> 10 times the upper limit of normal, cognitive decline, transaminitis, or allergic reactions.
* History of fibromyalgia or rheumatologic disease with symptoms that may be confounded with statin-related muscle co…
What they're measuring
1
The Mitochondrial Changes In Muscles During Statin Use
Timeframe: 10 weeks
Trial details
NCT IDNCT04507373
SponsorUniversity of Texas Southwestern Medical Center