Statin-Intolerance Registry (SIR)

• ClinicalTrials.gov Identifier: NCT04975594
• Recruitment Status: Active, not recruiting
• First Posted: July 23, 2021
• Last Update Posted: February 28, 2024
• Sponsor: University of Leipzig
• Collaborators: University of Jena; University Hospital Dresden; Charite University, Berlin, Germany
• Information provided by (Responsible Party): Ulrich Laufs, University of Leipzig

Tracking Information

• First Submitted Date: June 14, 2021
• First Posted Date: July 23, 2021
• Last Update Posted Date: February 28, 2024
• Actual Study Start Date: August 1, 2021
• Estimated Primary Completion Date: August 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2021)

• Number of treatment adjustments [ Time Frame: 3 years ]
• Change in LDL cholesterol level [ Time Frame: 3 years ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2021)

• Change in quality of life [ Time Frame: 3 years ]
  by EQ-5D
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Statin-Intolerance Registry
• Official Title: Statin-Intolerance Registry

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with statin-intolerance
• Condition: Dyslipidemias
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 14, 2021): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2026
• Estimated Primary Completion Date: August 2026 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT04975594
• Other Study ID Numbers: SIR-2021/05-UKL
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ulrich Laufs, University of Leipzig
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Leipzig
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Study Director: Ulrich Laufs; University of Leipzig

• PRS Account: University of Leipzig
• Verification Date: February 2024