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

Head-to-Head comparison of statins versus fibrates on laboratory parameters of atherosclerosis and ultrasound assessment of endothelial function

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001695190

Enrollment

200

Registered

2019-12-02

Start date

2019-12-18

Completion date

2020-12-10

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Healthy volunteers

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

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

Outcome results