Statin-Intolerance Registry

Dyslipidemias Clinical Trial

— SIR  

Official title:

Statin-Intolerance Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04975594
• Other study ID #: SIR-2021/05-UKL
• Status: Active, not recruiting
• Start date: August 1, 2021
• Est. completion date: August 2026

Study information

• Verified date: February 2024
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Participants are ? 18 years old

3. Written declaration of consent is available

4. 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:

1. Use of any experimental or investigational drugs within 30 days prior to screening.

2. An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-Investigator, or sponsor.

Related Conditions & MeSH terms

• Dyslipidemias

Locations

Country	Name	City	State
Germany	Uniklinik Leipzig	Leipzig	Saxony

Sponsors (4)

Lead Sponsor	Collaborator
University of Leipzig	Charite University, Berlin, Germany, University Hospital Dresden, University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment adjustments		3 years
Primary	Change in LDL cholesterol level		3 years
Secondary	Change in quality of life	by EQ-5D	3 years
Secondary	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)	3 years