Skip to main content
OpenTrials
Completed

NCT Number: NCT04895098

Statin Monotherapy or Statins in Combination With Ezetimibe in Patients for Prevention of CVD

Retrospective observational study of the efficacy and safety of statin monotherapy or statins in combination with ezetimibe in patients receiving lipid-lowering therapy in both primary and secondary prevention of cardiovascular diseases (CVD). The study will include patients receiving lipid-lowering therapy in both primary and secondary prevention of CVD who have received therapy of interest for ≥ 3 months in the 2 years preceding the signing of informed consent, i.e. statins as monotherapy or in combination with ezetimibe in a stable mode (without dose adjustment and/or statin replacement). Effectiveness of therapy will be evaluated based on the data on changes in baseline levels of total cholesterol (CS), low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides (TG), data on which will be obtained from primary medical records. Demographic and anthropometric data on patients, information on the history of hyperlipidemia and concomitant diseases will also be obtained. Also, the study will collect data on the development of adverse reactions of particular interest during therapy (liver/muscle damage, major cardiovascular events (MACE).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lipid Metabolism Disorders Cardiovascular Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FGBOU VO "ChGU named after I.N. Ulianova", Cheboksary, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient can be included in the study only once.

  • Age > 18 years.
  • Patient receiving lipid-lowering therapy with statin monotherapy or statins in combination with ezetimibe for both primary and secondary prevention of CVD.
  • Receiving statins as monotherapy or statins in combination with ezetimibe in a stable dosing regimen for 3 or more months at the time of enrolment in the study.
  • Willingness and ability to sign an informed consent to participate in the study.
  • Availability of primary medical documentation, which allows assessment of all parameters necessary for the study from the moment of initiation of statin monotherapy or statins in combination with ezetimibe.
  • Initiation of lipid-lowering therapy not earlier than 2 years before enrolment into the study.

Exclusion criteria

  • Age < 18 years.
  • A diagnosis of familial hypercholesterolemia made prior to study enrolment or the investigator's suspicious of the possible presence of familial hypercholesterolemia.
  • Change in lipid-lowering therapy within 3 months prior to study enrolment.
  • Concomitant administration of omega-3 PUFA with statin monotherapy or combination therapy of statins and ezetimibe, as well as the use of any methods of extracorporeal filtration and/or plasmapheresis.
  • Clinically significant impairment of liver and/or kidney function, which may impede interpretation of test results
  • Presence of hypothyroidism
  • Ezetimibe monotherapy
  • Intolerance to statins at any dose

Treatment and study plan

statin and ezetimibe combination therapy

Drug

Receiving statins (atorvastatin/rosuvastatin or others) in combination with ezetimibe 10mg/day in a stable dosing regimen (without changing the dose of the therapy and/or replacing the statin) for 3 or more months at the time of enrolment in the study.

Other names: no other intervention

statin monotherapy

Drug

Receiving statins (atorvastatin/rosuvastatin or others) as monotherapy in a stable dosing regimen (without changing the dose of the therapy and/or replacing the statin) for 3 or more months at the time of enrolment in the study.

Other names: no other intervention

Primary outcomes

  1. Frequency of achieving target LDL (%)

    Time frame: at the time of enrolment in the study

    Frequency of achieving target LDL cholesterol levels at the time of enrolment (%)

  2. Average change in LDL (absolute difference)

    Time frame: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study

    Average change in LDL cholesterol level from the moment of the index event to inclusion (absolute difference)

  3. Average change in LDL (% from the baseline)

    Time frame: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study

    Average change in LDL cholesterol level from the moment of the index event to inclusion (% from the baseline)

  4. Average change in total cholesterol (% and absolute difference)

    Time frame: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study

    Average change in total cholesterol level from the moment of the index event to inclusion (% and absolute difference)

  5. Average change in LDL (% and absolute difference)

    Time frame: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study

    Average change in LDL cholesterol level from the moment of the index event to inclusion (% and absolute difference)

  6. Average change in TG (% and absolute difference)

    Time frame: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study

    Average change in TG level from the moment of the index event to inclusion (% and absolute difference)

  7. The incidence of liver damage

    Time frame: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study

    an increase in ALT/AST levels over 1.5 of the upper limit normal [ULN]

  8. The frequency of development of muscle damage

    Time frame: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study

    an increase in CPK level while excluding other possible factors of the development of the disorder

  9. Major adverse cardiovascular events (MACE) incidence

    Time frame: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study

    Within the framework of this study, major adverse cardiovascular events (MACE) are considered as follows: myocardial infarction (MI), unstable angina pectoris, ischaemic stroke, aortocoronary bypass, mammary coronary bypass, coronary artery bypass, peripheral artery surgery, atherosclerotic stenosis of any artery more than 50%.

Sponsors and collaborators

Lead sponsor

Akrikhin

Industry

Collaborators

  • Russian National Atherosclerosis Society

Registry information

Official study title

Retrospective Observational Study of the Efficacy and Safety of Statin Monotherapy or Statins in Combination With Ezetimibe in Patients Receiving Lipid-lowering Therapy in Both Primary and Secondary Prevention of CVD

Acronym: UNISON

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 20, 2021
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.