Statin-Intolerance Registry

Active, not recruiting

• Conditions: Dyslipidemias

• Registration Number: NCT04975594
• Lead Sponsor: University of Leipzig

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.

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 Timeline

• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-23
• Study Start: 2021-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of treatment adjustments	3 years
Change in LDL cholesterol level	3 years

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	3 years	by EQ-5D
Development of muscle symptoms over time that initially lead to discontinuation of statin therapy	3 years	based on the "Statin-Associated Muscle Symptom Clinical Index" (SAMS-CI)

Trial Locations

Locations (1)

Uniklinik Leipzig; 🇩🇪 Leipzig, Saxony, Germany