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Active, Not Recruiting

NCT Number: NCT04975594

Statin-Intolerance Registry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniklinik Leipzig

Leipzig, Saxony, 04103, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Number of treatment adjustments

    Time frame: 3 years

  2. Change in LDL cholesterol level

    Time frame: 3 years

Secondary outcomes

  1. Change in quality of life

    Time frame: 3 years

    by EQ-5D

  2. Development of muscle symptoms over time that initially lead to discontinuation of statin therapy

    Time frame: 3 years

    based on the "Statin-Associated Muscle Symptom Clinical Index" (SAMS-CI)

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • Charite University, Berlin, Germany
  • University Hospital Dresden
  • University of Jena

Registry information

Acronym: SIR

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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