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Statin-Intolerance Registry (SIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04975594
Recruitment Status : Active, not recruiting
First Posted : July 23, 2021
Last Update Posted : February 28, 2024
Sponsor:
Collaborators:
University of Jena
University Hospital Dresden
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Ulrich Laufs, University of Leipzig

Study Description
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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.


Condition or disease
Dyslipidemias

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
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Statin-Intolerance Registry
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of treatment adjustments [ Time Frame: 3 years ]
  2. Change in LDL cholesterol level [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with statin-intolerance
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04975594


Locations
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Germany
Uniklinik Leipzig
Leipzig, Saxony, Germany, 04103
Sponsors and Collaborators
University of Leipzig
University of Jena
University Hospital Dresden
Charite University, Berlin, Germany
Investigators
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Study Director: Ulrich Laufs University of Leipzig
More Information
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Responsible Party: Ulrich Laufs, Prof. Dr. med, University of Leipzig
ClinicalTrials.gov Identifier: NCT04975594    
Other Study ID Numbers: SIR-2021/05-UKL
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ulrich Laufs, University of Leipzig:
Statins
Muscle symptoms
Cardiovascular
Lipid Metabolism Disorders
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases