Metabolic and Mitochondrial Changes in Statin-Induced Myopathy (NCT07511686) | Clinical Trial Compass
CompletedNot Applicable
Metabolic and Mitochondrial Changes in Statin-Induced Myopathy
Latvia38 participantsStarted 2023-08-22
Plain-language summary
The goal of this observational study is to learn whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells, specifically involving acylcarnitines, in adults taking or not taking statins. The main questions it aims to answer are:
Do patients with statin-associated muscle symptoms have higher acylcarnitine levels in blood and muscle compared to statin users without symptoms and people not taking statins? Do acylcarnitine levels decrease after stopping or reducing statin treatment in affected patients?
Researchers will compare patients with statin-associated muscle symptoms, statin users without symptoms, and individuals not taking statins to see if differences in acylcarnitine levels and muscle metabolism are associated with muscle symptoms.
Participants will:
Provide blood samples for biochemical tests and acylcarnitine analysis Share information about their health, medications, and lifestyle (Optional) undergo a muscle biopsy to study muscle metabolism Some participants with muscle symptoms will have repeat blood tests and possibly a repeat muscle biopsy after statin dose reduction or discontinuation to track changes over time
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age at least 18 years.
. A representative of the Caucasian race.
. The patient agrees to participate in the study by signing an informed consent form for participation in the study. (The patient may only be included in the muscle biopsy sub-study if the relevant additional informed consent form has also been signed.)
. Specific inclusion criteria for each of the study subgroups:
. Group A: patients have elevated creatine kinase levels \>1.5x above the upper limit of normal (women \>325 U/L and men \>504 U/L) with or without muscle symptoms that have no other obvious explanation (including intense physical activity in the last 7 days).
. Group B: atorvastatin 40-80 mg or rosuvastatin 20-40 mg monotherapy for at least 8 weeks at a constant dose and no muscle symptoms (pain, weakness, fatigue, cramps) during this period, CK \<200 U/L.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Group C: no lipid-lowering agents have been used during the last year and there have been no muscle symptoms (pain, weakness, fatigue, cramps) of unknown origin lasting \>1 week during this period, CK \<200 U/L.
Exclusion criteria
. Any disease that, in the opinion of the investigator, could also cause a significant increase in CK or muscle symptoms.
. Use of other cholesterol-lowering agents specific to each of the study groups:
. Group A: use of red yeast rice extract, fibrates, or bempedoic acid within the last 8 weeks.
. Group B: use of other non-statin cholesterol-lowering agents (red yeast rice extract, ezetimibe, fibrates, PCSK9 inhibitors, inclisiran, bempedoic acid) in the last 8 weeks.
. Group C: use of any cholesterol-lowering agents (statins, red yeast rice extract, ezetimibe, fibrates, PCSK9 inhibitors, inclisiran, bempedoic acid) in the last 12 weeks.
. Intense physical activity in the last 7 days.
. Acute myocardial infarction or stroke in the last 4 weeks.
. Major surgery within the last 4 weeks (invasive cardiac procedures are not an exclusion criterion).