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

January 11, 2023 updated by: Akrikhin

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Cheboksary, Russian Federation, 428015
        • FGBOU VO "ChGU named after I.N. Ulianova"
      • Chita, Russian Federation, 672000
        • FGBOU VO "ChGMA" Ministery of Health Russia
      • Ekaterinburg, Russian Federation, 620028
        • FGBOU VO "UGMU" Ministry of Health Russia
      • Irkutsk, Russian Federation, 664049
        • Gbuz "Iokb"
      • Kazan, Russian Federation, 420103
        • Gauz "Gkb #7"
      • Kemerovo, Russian Federation, 650002
        • Nii "Kpssz"
      • Kirov, Russian Federation, 610011
        • KOGBUZ "Severnaya klinicheskaya bolnitca skoroi meditcinskoi pomotschi"
      • Krasnodar, Russian Federation, 350004
        • OOO TsEN YUG
      • Lipetsk, Russian Federation, 398004
        • GUZ "Lipetskaya Gorpolyklinika #7"
      • Magnitogorsk, Russian Federation, 455034
        • ООО "MC "Semeiny doctor"
      • Magnitogorsk, Russian Federation, 455044
        • OOO "Semeiny doctor"
      • Moscow, Russian Federation, 101000
        • Fgbu Mnic Pm Ministry of Health Russia
      • Moscow, Russian Federation, 119296
        • OOO ''Ne bolit"
      • Moscow, Russian Federation, 121552
        • FGBU NMIC of Cardiology Ministry of heath RF
      • Moscow, Russian Federation, 125993
        • FGBOU DPO RMANPO Ministry of Health
      • Moscow, Russian Federation, 129128
        • Chuz ''Ckb Rzhd Medicina"
      • Moscow, Russian Federation, 129226
        • Osp Rgnkc
      • Nizhny Novgorod, Russian Federation, 603000
        • GBUZ NO "Gorodskaya Klinicheskaya Bolnitsa #38"
      • Nizhny Novgorod, Russian Federation, 603005
        • Gbuz No "Gkb #5"
      • Nizhny Novgorod, Russian Federation, 603022
        • OOO "DaVinchi-NN"
      • Novosibirsk, Russian Federation, 630089
        • NII TPM - affiliate of SO RAN
      • Omsk, Russian Federation, 644024
        • Buzoo "Kkd"
      • Petrozavodsk, Russian Federation, 185031
        • Gbus "Bsmp"
      • Saint Petersburg, Russian Federation, 191015
        • FGBOU VO SZGMU named after I.I.Mechnikov
      • Saint Petersburg, Russian Federation, 194291
        • FGBU "SZONKC named after L.G.Sokolov FMBA of Russia"
      • Saint Petersburg, Russian Federation, 195267
        • Ooo "Veraks-Med"
      • Samara, Russian Federation, 443070
        • GBUZ "SOKKD named after V.P.Polyakov"
      • Tyumen, Russian Federation, 625023
        • Fgbou Vo Tyumensky Gmu Ministry of Health Russia
      • Ulyanovsk, Russian Federation, 432071
        • Cardiology cabinet "Serdce pod zaschitoy" IP Barov P.A.
      • Vladimir, Russian Federation, 600020
        • GBUZ VO "City hospital #4 of Vladimir"
      • Vladimir, Russian Federation, 600020
        • GBUZ VO "GB #4 c. Vladimir"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

Patient can be included in the study only once.

  1. Age > 18 years.
  2. Patient receiving lipid-lowering therapy with statin monotherapy or statins in combination with ezetimibe for both primary and secondary prevention of CVD.
  3. 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.
  4. Willingness and ability to sign an informed consent to participate in the study.
  5. 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.
  6. Initiation of lipid-lowering therapy not earlier than 2 years before enrolment into the study.

Exclusion Criteria:

  1. Age < 18 years.
  2. A diagnosis of familial hypercholesterolemia made prior to study enrolment or the investigator's suspicious of the possible presence of familial hypercholesterolemia.
  3. Change in lipid-lowering therapy within 3 months prior to study enrolment.
  4. 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.
  5. Clinically significant impairment of liver and/or kidney function, which may impede interpretation of test results
  6. Presence of hypothyroidism
  7. Ezetimibe monotherapy
  8. Intolerance to statins at any dose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
combination therapy group
750 Subjects in the statin and ezetimibe combination therapy group
Drug: statin and ezetimibe combination therapy
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
monotherapy group
250 Subjects in the statin monotherapy group
Drug: statin monotherapy
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 (%)
at the time of enrolment in the study
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)
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 (% 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)
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 (% 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)
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 (% 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)
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 (% 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)
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
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]
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
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
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
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%.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akrikhin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Russian National Atherosclerosis Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Igor V Sergienko, MD,PHD,Prof., Russian National Atherosclerosis Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EZE-01/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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