Statin-Intolerance Registry

NCT04975594 | Active Not Recruiting

• 1 other identifier: SIR-2021/05-UKL
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. Patients will be systematically and prospectively included and followed by the registry.

Conditions

Dyslipidemias

Keywords

Statins; Muscle symptoms; Cardiovascular; Lipid Metabolism Disorders

Outcome Measures

Primary Outcomes (2)

• Number of treatment adjustments

  3 years

• Change in LDL cholesterol level

  3 years

Secondary Outcomes (2)

• Change in quality of life

  3 years

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

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with statin-intolerance

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leipzig: lead
• University of Jena: collaborator
• University Hospital Dresden: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Uniklinik Leipzig

Leipzig, Saxony, 04103, Germany

Location

MeSH Terms

Conditions

Dyslipidemias; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ulrich Laufs

  University of Leipzig

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 23, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

DE (1)