DyslipidemiasSIRNCT04975594
Statin-Intolerance Registry
An observational study of Dyslipidemias, run by University of Leipzig at 1 site in Germany.
Trial summary
The Statin-Intolerance Registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic cardiovascular disease (ASCVD) prevention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemias
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with statin-intolerance
Who may be able to join
- Patients with dyslipidemia and statin intolerance, defined as:
- Use of 2 or more statins and intolerance of these drugs in any dose or inability to tolerate dosage increasement beyond a maximum weekly dose of 70 mg atorvastatin, 140 mg Simvastatin, pravastatin, or lovastatin, 35 mg rosuvastatin, 280 mg of Fluvastatin and symptoms improve or disappear when statin is reduced in dosage or discontinued
- Participants are ≧ 18 years old
- Written declaration of consent is available
- The patient is cognitively, linguistically and organizationally capable to meet the study requirements. The possibility of 1 year follow-up is very likely.
Who cannot join
- Use of any experimental or investigational drugs within 30 days prior to screening.
- An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-Investigator, or sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
The Statin-Intolerance Registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic cardiovascular disease (ASCVD) prevention.
Patients will be systematically and prospectively included and followed by the registry.
Read the detailed description
This non-interventional registry based on routine clinical practice will collect data under real-life conditions. The treatment of patients will not be changed by this study.
Data on patient characteristics and the treatment history will be collected via questionnaires at study entree. Yearly follow up visits will re-assess the baseline parameters and document cardiovascular events.
The data will be analyzed using descriptive statistics.
- Conditions
- Dyslipidemias
- Keywords
- Statins, Muscle symptoms, Cardiovascular, Lipid Metabolism Disorders
- Medical subject headings
- Dyslipidemias, Lipid Metabolism Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment adjustments
Measured: 3 years
Change in LDL cholesterol level
Measured: 3 years
Secondary outcomes (2)
Change in quality of life
by EQ-5D
Measured: 3 years
Development of muscle symptoms over time that initially lead to discontinuation of statin therapy
based on the "Statin-Associated Muscle Symptom Clinical Index" (SAMS-CI)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Aug 2021
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena, University Hospital Dresden, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Ulrich Laufs, University of Leipzig
- Investigators
- Ulrich Laufs, Study director, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975594
- Sponsor's protocol ID
- SIR-2021/05-UKL
- Acronym
- SIR
- Status last verified
- Feb 2026
- First submitted
- 14 Jun 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin-Intolerance Registry
- ClinicalTrials.gov ID
- NCT04975594
- Acronym / sponsor ID
- SIR / SIR-2021/05-UKL
- Conditions
- Dyslipidemias
- Keywords
- Statins, Muscle symptoms, Cardiovascular, Lipid Metabolism Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- University of Jena, University Hospital Dresden, Charite University, Berlin, Germany
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Statin-Intolerance Registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic cardiovascular disease (ASCVD) prevention.
Patients will be systematically and prospectively included and followed by the registry.
Detailed description
This non-interventional registry based on routine clinical practice will collect data under real-life conditions. The treatment of patients will not be changed by this study.
Data on patient characteristics and the treatment history will be collected via questionnaires at study entree. Yearly follow up visits will re-assess the baseline parameters and document cardiovascular events.
The data will be analyzed using descriptive statistics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with statin-intolerance
Key inclusion criteria (5 listed)
- Patients with dyslipidemia and statin intolerance, defined as:
- Use of 2 or more statins and intolerance of these drugs in any dose or inability to tolerate dosage increasement beyond a maximum weekly dose of 70 mg atorvastatin, 140 mg Simvastatin, pravastatin, or lovastatin, 35 mg rosuvastatin, 280 mg of Fluvastatin and symptoms improve or disappear when statin is reduced in dosage or discontinued
- Participants are ≧ 18 years old
- Written declaration of consent is available
- The patient is cognitively, linguistically and organizationally capable to meet the study requirements. The possibility of 1 year follow-up is very likely.
Key exclusion criteria (2 listed)
- Use of any experimental or investigational drugs within 30 days prior to screening.
- An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-Investigator, or sponsor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of treatment adjustments
Time frame: 3 years
Change in LDL cholesterol level
Time frame: 3 years
2 secondary outcomes
Change in quality of life
Time frame: 3 years
Development of muscle symptoms over time that initially lead to discontinuation of statin therapy
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Laufs study director
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by University of Leipzig at 1 site in Germany.
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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of treatment adjustments (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.