The effect of statins in comparison to fibrates on the development of atherosclerosis

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Hypertriglyceridemia; Public Health - Other public health; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12619001695190
• Lead Sponsor: Jagiellonian University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Study Completion: 2020-12-10
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Police officers with dyslipidemia aged from 30 to 60 years. Inclusion criterion: triglyceride concentration> 1.7 mmol / L, or LDL-cholesterol> 3.0 mmol /

Exclusion Criteria

•Acute coronary episode in the last 3 months; heart failure, defined as left ventricular ejection fraction (EF) <40% in echocardiography.
•Use of hypolipemic drugs or vitamins• recent infections
•Impaired renal function (serum creatinine> 177 µmol / L)
•Liver damage (ALT> 3-fold upper limit of normal), CPK> 10-fold limit of normal
•The presence of cancer and thyroid disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of vascular endothelial function as a change in brachia artery dilation expressed as a percentage (%).<br><br>Imaging studies, aimed at measuring the surrogate markers of atherosclerosis, were also completed using an ultrasonograph (Sequoia 512, Mountain View, Ca, USA) with a 6 MHz linear transducer. The measurements of flow-mediated dilation (FMD) of brachial artery in response to reactive hyperemia were evaluated non-invasively, in compliance with the ultrasound method described by Celermajer (Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, et al. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992;340:1111-1115).[Measurement every 2 months ]

Secondary Outcome Measures

Name	Time	Method
Evaluation of vascular remodeling of carotid IMT expressed in mm.<br>Imaging studies, aimed at measuring the surrogate markers of atherosclerosis, were also completed using an ultrasonograph (Sequoia 512, Mountain View, Ca, USA) with a 6 MHz linear transducer.<br>IMT measurements of the distal wall of the carotid artery were taken in three locations: i.e. 1. common carotid artery (2 cm below the bulb), 2. carotid artery bulb, and 3. proximal internal carotid artery. The final IMT value was the mean from all measurements on both carotid arteries. [Before and after 2, 4, 6, 9, 12, 18, and 24 months]