Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment

Sponsor
University Medical Centre Ljubljana
Study ID
NCT04613167
Status
Unknown

Conditions

  • Acute Coronary Syndrome
  • Genetic Polymorphisms
  • Inflammation
  • Lipoproteinemia
  • Premature Coronary Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    The first group will receive alirocumab. Blood samples from all patients will be drawn for laboratory measurements and genetics determination. Ultrasound measurement of endothelium-dependent dilatation of the brachial artery, intima media thickness of carotid arteries and pulse wave will be measured.
  • Evolocumab — DRUG
    The second group will receive evolocumab. Blood samples from all patients will be drawn for laboratory measurements and genetics determination. Ultrasound measurement of endothelium-dependent dilatation of the brachial artery, intima media thickness of carotid arteries and pulse wave will be measured.
  • Control group — DRUG
    The third group will receive only optimal guidelines-based secondary preventive treatment. Blood samples from all patients will be drawn for laboratory measurements and genetics determination. Ultrasound measurement of endothelium-dependent dilatation of the brachial artery, intima media thickness of carotid arteries and pulse wave will be measured.

Study Details

The aim of study is to examine the relationship between lipid subfractions, inflammation and structural-functional properties of the arterial wall in patients with premature coronary heart disease, to study genetic polymorphisms that determine lipid subfractions concentration on the functional and morphological properties of the arterial vascular wall in patients with early coronary heart disease, to study the effect of alirocumab and evolocumab on lipid subfractions, inflammation and structural-functional properties of arterial wall in patients with early coronary atherosclerosis and to study the influence of NOS-3 gene expression on the functional and morphological properties of the arterial vascular wall in the same patients. Impaired blood fat metabolism and chronic inflammation are intertwined as possible causes of atherosclerosis. Lipoprotein (a) (Lp (a)) is an important risk factor for coronary heart disease and a prognostic predictor in patients after myocardial infarction, but recent research suggests that subtilisin-kexin convertase type 9 (PCSK9) inhibitors are the only drugs that significantly reduce serum Lp (a) concentration. However, there are no data on the relationship between Lp (a) values and polymorphisms for Lp (a), indicators of inflammation and impaired arterial function, and response to treatment with various PCSK9 inhibitors in patients with early coronary heart disease.

Key Dates

Start date
Nov 10, 2020
Status verified
Oct 2020
Primary completion
Jun 30, 2021
Completion
Oct 1, 2021

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab
    The first group of patients will receive 150 mg of alirocumab every two weeks subcutaneously for 6 months
  • Experimental: Evolocumab
    the second group of patients will receive evolocumab 140 mg every two weeks subcutaneously for 6 months
  • Experimental: Control group
    Control group will be included in the treatment after 6 months. During this time, the control group will not receive treatment with alirocumab or evolocumab, only standard guidelines-based treatment

Primary Outcome Measure

Ultrasound functional and morphological properties of the arterial wall and Lp (a) concentration [ Time Frame: Baseline ]

Central Contacts

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