Uniklinik Leipzig
Leipzig, Saxony, 04103, Germany
NCT Number: NCT04975594
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Leipzig, Saxony, 04103, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
Time frame: 3 years
Time frame: 3 years
Time frame: 3 years
by EQ-5D
Time frame: 3 years
based on the "Statin-Associated Muscle Symptom Clinical Index" (SAMS-CI)
University of Leipzig
Other
Acronym: SIR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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