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Could a simple blood test predict statin muscle pain?

NCT ID NCT07511686

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed observational study from Latvia looked at whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells. Researchers measured acylcarnitine levels in blood and muscle samples from 38 adults, comparing those with statin-related muscle pain, those taking statins without symptoms, and people not taking statins. The goal was to see if acylcarnitine levels could help explain or predict muscle side effects from statins.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help explain why some people get muscle pain from statins and point toward ways to predict or manage this side effect.
What could go wrong
This is a small, observational study (38 participants) that only measures biological markers, not a treatment. Results may not apply to all populations or lead to direct clinical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

38 people

The number who actually took part.

Started

Aug 2023

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of adult participants (≥18 years) of Caucasian ethnicity recruited at the Latvian Cardiology Center of Pauls Stradiņš Clinical University Hospital. The study includes three groups: (1) patients with elevated creatine kinase levels with or without muscle symptoms suggestive of statin-associated muscle myopathy, (2) patients receiving stable high-dose statin therapy without muscle symptoms, and (3) individuals not receiving lipid-lowering therapy and without unexplained muscle symptoms. Participants may be hospitalized patients or outpatients, including referrals from other medical institutions. All participants must provide written informed consent, and a subset of participants may additionally consent to undergo muscle biopsy for further analysis of mitochondrial metabolism in muscle tissue.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age at least 18 years. 2. A representative of the Caucasian race. 3. 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.) 4. Specific inclusion criteria for each of the study subgroups: 1. 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). 2. 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. 3. 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: 1. Any disease that, in the opinion of the investigator, could also cause a significant increase in CK or muscle symptoms. 2. Use of other cholesterol-lowering agents specific to each of the study groups: 1. Group A: use of red yeast rice extract, fibrates, or bempedoic acid within the last 8 weeks. 2. 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. 3. 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. 3. Intense physical activity in the last 7 days. 4. Acute myocardial infarction or stroke in the last 4 weeks. 5. Major surgery within the last 4 weeks (invasive cardiac procedures are not an exclusion criterion). 6. Patients with severe illness that, in the investigator's opinion, may significantly affect the patient's overall metabolism (e.g., active malignancy, terminal heart failure, etc.). 7. Excessive alcohol consumption (binge drinking or \>7 units of alcohol per day) within the last year. 8. Use of other substances or medications known to have direct myotoxic effects (e.g., fibrates, cyclosporins, labetalol, propofol, procainamide, interferon-alpha, hydroxyurea, zidovudine, colchicine, vincristine, amiodarone, corticosteroids) or that may affect CK elevation. 9. Use of meldonium within the last 2 months.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Latvia (Faculty of Medicine and Institute of Cardiology and Regenerative Medicine)

    Riga, Latvia

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Other studies related to the condition(s) this trial covers.