Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001695190
Ethics application status
Approved
Date submitted
27/09/2019
Date registered
2/12/2019
Date last updated
10/06/2021
Date data sharing statement initially provided
2/12/2019
Date results information initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of statins in comparison to fibrates on the development of atherosclerosis
Scientific title
Head-to-Head comparison of statins versus fibrates on laboratory parameters of atherosclerosis and ultrasound assessment of endothelial function
Secondary ID [1] 298753 0
None
Universal Trial Number (UTN)
U1111-1237-4184
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 313770 0
Hypertriglyceridemia 315363 0
Condition category
Condition code
Public Health 312175 312175 0 0
Other public health
Cardiovascular 312266 312266 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Simvastatin 20 mg once daily
The duration of administration: 2 years
Oral tablet
Monitoring of intervention:
Laboratory control LDL cholesterol and triglycerides in serum,
Participant diary
Returning the packaging after used medicine
LDL cholesterol >3.0 mmol/L
Participants will be assigned to the intervention based on participants LDL level at enrolment
Intervention code [1] 315154 0
Treatment: Drugs
Intervention code [2] 315155 0
Diagnosis / Prognosis
Comparator / control treatment
Fenofibrate 215 mg
The duration of administration: 2 years
Oral tablet
Monitoring of intervention:
Laboratory control LDL cholesterol and triglycerides in serum.
Participant diary
Returning the packaging after used medicine
Triglycerides >1.7 mmol/L
Participants will be assigned to the intervention based on participants triglycerides level at enrolment
Control group
Active

Outcomes
Primary outcome [1] 320904 0
Evaluation of vascular endothelial function as a change in brachia artery dilation expressed as a percentage (%).

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).
Timepoint [1] 320904 0
Measurement every 2 months
Secondary outcome [1] 373304 0
Evaluation of vascular remodeling of carotid IMT expressed in mm.
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.
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.
Timepoint [1] 373304 0
Before and after 2, 4, 6, 9, 12, 18, and 24 months

Eligibility
Key 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 / L
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/12/2019
Actual
18/12/2019
Date of last participant enrolment
Anticipated
Actual
10/12/2020
Date of last data collection
Anticipated
Actual
10/12/2020
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 21732 0
Poland
State/province [1] 21732 0
Malopolska

Funding & Sponsors
Funding source category [1] 303309 0
University
Name [1] 303309 0
Jagiellonian University School of Medicine
Country [1] 303309 0
Poland
Primary sponsor type
University
Name
Jagiellonian University School of Medicine
Address

31-008 Krakow
ul. Anny 12
Country
Poland
Secondary sponsor category [1] 303333 0
None
Name [1] 303333 0
Address [1] 303333 0
Country [1] 303333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303844 0
Bioethical Commission of the Jagiellonian University
Ethics committee address [1] 303844 0
31-531 Krakow
ul. Grzegorzecka 20
Ethics committee country [1] 303844 0
Poland
Date submitted for ethics approval [1] 303844 0
12/04/2019
Approval date [1] 303844 0
24/04/2019
Ethics approval number [1] 303844 0
1072.6120.116.2019

Summary
Brief summary
Treatment with statins and fibrates improves endothelial function.
Assessment of the effect of pharmacotherapy (statin or fibrates) on the diastolic response of the brachial artery, the carotid artery IMT and the concentration of pro-inflammatory, thrombotic and oxidative stress markers in subjects with dyslipidemia.
We plan to include 200 police officers in the study, of which 50 will be treated with a statin (20 mg/day) and 50 subjects treated with fenofibrate (215 mg/day) for 24 months.
The results of the study may broaden the knowledge about the increased progression of atherosclerosis in the group to be exposed to more stressors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94998 0
A/Prof Teresa Domagala
Address 94998 0
Department of Medical Biochemistry,
Jagiellonian University School of Medicine,
31-034 Krakow
Country 94998 0
Poland
Phone 94998 0
+48124227400
Fax 94998 0
+48 12 422 32 72
Email 94998 0
domagala32@yahoo.com
Contact person for public queries
Name 94999 0
A/Prof Teresa Domagala
Address 94999 0
Department of Medical Biochemistry,
Jagiellonian University School of Medicine,
31-034 Krakow
Country 94999 0
Poland
Phone 94999 0
+48 12 422 74 00
Fax 94999 0
+48 12 422 32 72
Email 94999 0
domagala32@yahoo.com
Contact person for scientific queries
Name 95000 0
A/Prof Teresa Domagala
Address 95000 0
Department of Medical Biochemistry,
Jagiellonian University School of Medicine,
31-034 Krakow
Country 95000 0
Poland
Phone 95000 0
+48 12 422 74 00
Fax 95000 0
+48 12 422 32 72
Email 95000 0
domagala32@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age, sex, clinical parameters
When will data be available (start and end dates)?
16.12.2019 - 16.12.2022
Available to whom?
only researchers
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Principal Investigator Teresa Domagala

domagala32@yahoo.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5121Study protocol  domagala32@yahoo.com



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.