BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease
NCT ID: NCT05814692
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
130 participants
OBSERVATIONAL
2022-09-14
2024-09-30
Brief Summary
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Detailed Description
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Statin therapy is known to improve clinical outcomes in patients with coronary artery disease (CAD), while being highly cost-effective. However, adherence to statin therapy in real world settings is suboptimal and represents a possible target to ameliorate secondary CAD disease prevention. Previous interventional studies on statin adherence showed inconsistent results and it is widely acknowledged that a tailored adherence improvement approach adapted to patient determinants is required. However, methodology to accurately detect and characterize non-adherent patients is challenging and constitutes an important obstacle to developing such interventions. Urine analysis with liquid chromatography/mass spectrometry (LC-MS) for detection of statin intake is a promising method for objective measurement of adherence as an adjunct to subjective adherence assessment using questionnaires, which has not been applied in CAD patients in Germany.
Objectives: In this pilot study (i) a feasibility testing of objective (LC-MS urine analysis) and subjective (questionnaire survey) measures of adherence to statin therapy will be performed, (ii) the prevalence of nonadherence in the target population will be determined , and (iii) instruments assessing possible factors associated with (non-)adherence (e.g. side effects, beliefs about medications, and disease-related knowledge) will be evaulated, in order to establish a methodological ground for further studies characterizing non-adherent patients.
Methods:
Outpatients with CAD treated in University Hospital Düsseldorf and receiving guideline-recommended atorvastatin or rosuvastatin on prescription will be included in the pilot study. Based on sample size calculation about 130 patients will be recruited. A biochemical method of objective urine measurement of statin intake by LC-MS will be combined with a preselected set of questionnaires on adherence behavior and associated factors. Clinical characteristics will be obtained from patient records. A sub-sample of the study population will be invited to participate in the interview for the evaluation of the questionnaire survey.
Outlook:
Based on the results of the pilot study, an adequately powered study to characterize non-adherent patients and identify patterns of non-adherence will be conducted. The results will be used for the development of a complex tailored intervention for non-adherent patients in Germany.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Interventions
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blood and urine samples
blood and urine samples
Eligibility Criteria
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Inclusion Criteria
* prescription of atorvastatin or rosuvastatin
Exclusion Criteria
* impairment (e.g. dementia)
* language barrier (German)
* end-stage kidney disease with hemodialysis
18 Years
ALL
No
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Principal Investigators
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Malte Kelm, Prof.
Role: STUDY_CHAIR
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Locations
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University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BIO-FACTS
Identifier Type: -
Identifier Source: org_study_id
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