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

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ClinicalTrials.gov Identifier: NCT04613167
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Miran Sebestjen, University Medical Centre Ljubljana

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Premature Coronary Heart Disease Lipoproteinemia Inflammation Genetic Polymorphisms Drug: Alirocumab Drug: Evolocumab Drug: Control group Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genetic, Biochemical and Functional Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment Options
Estimated Study Start Date : November 10, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Alirocumab
The first group of patients will receive 150 mg of alirocumab every two weeks subcutaneously for 6 months
 Drug: Alirocumab
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.
Experimental: Evolocumab
the second group of patients will receive evolocumab 140 mg every two weeks subcutaneously for 6 months
 Drug: Evolocumab
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.
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
 Drug: Control group
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.


Outcome Measures
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Primary Outcome Measures :
  1. Ultrasound functional and morphological properties of the arterial wall and Lp (a) concentration [ Time Frame: Baseline ]
    Functional and morphological characteristics of arterial wall will correlate to Lp (a) concentrations.

  2. Concentration of Lp (a) and SNP in the LPA gene [ Time Frame: Baseline ]
    The serum concentration of Lp (a) will correlate with single nucleotide polymorphisms (SNP) in the LPA gene

  3. The effect of alirocumab or evolocumab on functional and morphological properties of arterial wall after 6 months [ Time Frame: 6 months ]
    Both drugs will improve functional and morphological properties of arterial wall in with no difference between the drugs. We expect the improvements in each drug group will be in correlation with the decrease of Lp (a) concentration.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 6 months after acute coronary syndrome,
  • up to 55 years at the time of first acute coronary syndrome
  • concentration Lp (a) above 1000 mg / L or Lp (a) above 600 mg / L and LDL above 2.6 mmol / L
  • optimally treated risk factors for cardiovascular events according to currently valid guidelines.

Exclusion Criteria:

  • Age <18 years or > 65 years,
  • documented history of myocardial infarction less than 6 months before enrollment
  • secondary dyslipidemia,
  • severe renal disease (oGFR <30 ml / min),
  • moderate to severe liver disease (elevated transaminases above 3 times the norm, elevated bilirubin above 2 times the norm, elevated creatinine kinase above 3 times the norm),
  • acute illness 6 weeks before inclusion in the study,
  • history of allergic reaction to any ingredient in the drug,
  • pregnancy and lactation,
  • life expectancy less than 12 months,
  • unwillingness to participate or lack of availability for follow-up
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613167


Contacts
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Contact: Miran Šebeštjen, prof. +38615228541 miran.sebestjen@guest.arnes.si, miran.sebestjen@kclj.si
Contact: Andreja Rehberger Likozar, MD +38615228012 rehbergerandreja@gmail.com, andreja.rehbergerlikozar@kclj.si

Locations
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Slovenia
University Medical Centre Ljubljana-Department of Vascular diseases and dept. of Cardiology Recruiting
Ljubljana, Slovenia, 1000
Contact: Miran Šebeštjen, prof, PhD    +38615224811    miran.sebestjen@kclj.si   
Contact: Andreja Rehberger Likozar, MD    +38615228012    andreja.rehbergerlikozar@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Study Chair: Miran Šebeštjen, prof. University Medical Centre Ljubljana (Slovenia)
Principal Investigator: Andreja Rehberger Likozar, MD University Medical Centre Ljubljana (Slovenia)
More Information
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Publications:

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Responsible Party: Miran Sebestjen, Professor, principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT04613167    
Other Study ID Numbers: GEBI
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miran Sebestjen, University Medical Centre Ljubljana:
Coronary heart disease
Acute coronary syndrome
Lipoprotein (a)
Genetics
Secondary prevention
 Endothelium
Inflammation
Genetic polymorphisms
NO synthetase
Dyslipidemia
Additional relevant MeSH terms:
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Premature Birth
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Acute Coronary Syndrome
Inflammation
Pathologic Processes
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Evolocumab
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents