Lipid Metabolism DisordersUNISONNCT04895098
Statin Monotherapy or Statins in Combination With Ezetimibe in Patients for Prevention of CVD
An observational study of Lipid Metabolism Disorders and Cardiovascular Diseases, run by Akrikhin at 31 sites in Russia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipid Metabolism Disorders, Cardiovascular Diseases
- What is being tested?
- statin and ezetimibe combination therapy and statin monotherapy
- How many people
- 1,000 participants
- Where
- 31 sitesRussia
- Study dates
- 23 Jun 2021to 8 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Russia31 sites
FGBOU VO "ChGU named after I.N. Ulianova"
Cheboksary, 428015
FGBOU VO "ChGMA" Ministery of Health Russia
Chita, 672000
Gbuz "Iokb"
Irkutsk, 664049
Gauz "Gkb #7"
Kazan', 420103
Nii "Kpssz"
Kemerovo, 650002
KOGBUZ "Severnaya klinicheskaya bolnitca skoroi meditcinskoi pomotschi"
Kirov, 610011
OOO TsEN YUG
Krasnodar, 350004
GUZ "Lipetskaya Gorpolyklinika #7"
Lipetsk, 398004
ООО "MC "Semeiny doctor"
Magnitogorsk, 455034
OOO "Semeiny doctor"
Magnitogorsk, 455044
Fgbu Mnic Pm Ministry of Health Russia
Moscow, 101000
OOO ''Ne bolit"
Moscow, 119296
FGBU NMIC of Cardiology Ministry of heath RF
Moscow, 121552
FGBOU DPO RMANPO Ministry of Health
Moscow, 125993
Chuz ''Ckb Rzhd Medicina"
Moscow, 129128
Osp Rgnkc
Moscow, 129226
GBUZ NO "Gorodskaya Klinicheskaya Bolnitsa #38"
Nizhny Novgorod, 603000
Gbuz No "Gkb #5"
Nizhny Novgorod, 603005
OOO "DaVinchi-NN"
Nizhny Novgorod, 603022
NII TPM - affiliate of SO RAN
Novosibirsk, 630089
Buzoo "Kkd"
Omsk, 644024
Gbus "Bsmp"
Petrozavodsk, 185031
FGBOU VO SZGMU named after I.I.Mechnikov
Saint Petersburg, 191015
FGBU "SZONKC named after L.G.Sokolov FMBA of Russia"
Saint Petersburg, 194291
Ooo "Veraks-Med"
Saint Petersburg, 195267
GBUZ "SOKKD named after V.P.Polyakov"
Samara, 443070
Fgbou Vo Tyumensky Gmu Ministry of Health Russia
Tyumen, 625023
Cardiology cabinet "Serdce pod zaschitoy" IP Barov P.A.
Ulyanovsk, 432071
GBUZ VO "City hospital #4 of Vladimir"
Vladimir, 600020
GBUZ VO "GB #4 c. Vladimir"
Vladimir, 600020
FGBOU VO "UGMU" Ministry of Health Russia
Yekaterinburg, 620028
About this study
Official 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
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).
- Being tested
- statin and ezetimibe combination therapy, statin monotherapy
- Keywords
- Ezetimibе, Statin, Cardiovascular diseases, Lipid-lowering therapy
- Medical subject headings
- Lipid Metabolism Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
statin and ezetimibe combination therapyDrug
Also called no other intervention
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.
statin monotherapyDrug
Also called no other intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| combination therapy group | 750 Subjects in the statin and ezetimibe combination therapy group Receives: Drug: statin and ezetimibe combination therapy | |
| monotherapy group | 250 Subjects in the statin monotherapy group Receives: Drug: statin monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of achieving target LDL (%)
Frequency of achieving target LDL cholesterol levels at the time of enrolment (%)
Measured: at the time of enrolment in the study
Average change in LDL (absolute difference)
Average change in LDL cholesterol level from the moment of the index event to inclusion (absolute difference)
Measured: 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)
Average change in LDL cholesterol level from the moment of the index event to inclusion (% from the baseline)
Measured: 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)
Average change in total cholesterol level from the moment of the index event to inclusion (% and absolute difference)
Measured: 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)
Average change in LDL cholesterol level from the moment of the index event to inclusion (% and absolute difference)
Measured: 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)
Average change in TG level from the moment of the index event to inclusion (% and absolute difference)
Measured: 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
an increase in ALT/AST levels over 1.5 of the upper limit normal [ULN]
Measured: 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
an increase in CPK level while excluding other possible factors of the development of the disorder
Measured: 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
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%.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start23 Jun 2021
- Primary completion25 Nov 2021
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akrikhin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Russian National Atherosclerosis Society
- Responsible party
- Sponsor
- Investigators
- Igor V Sergienko, MD,PHD,Prof., Principal investigator, Russian National Atherosclerosis Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895098
- Sponsor's protocol ID
- EZE-01/21
- Acronym
- UNISON
- Status last verified
- Jan 2023
- First submitted
- 17 May 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04895098
- Acronym / sponsor ID
- UNISON / EZE-01/21
- Keywords
- Ezetimibе, Statin, Cardiovascular diseases, Lipid-lowering therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AkrikhinIndustry (pharma, biotech, devices)
- Collaborators
- Russian National Atherosclerosis Society
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination therapy group | – | Drug: statin and ezetimibe combination therapy750 Subjects in the statin and ezetimibe combination therapy group |
| monotherapy group | – | Drug: statin monotherapy250 Subjects in the statin monotherapy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| statin and ezetimibe combination therapyAlso: no other interventionReceiving 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. | Drug | combination therapy group |
| statin monotherapyAlso: no other interventionReceiving 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. | Drug | monotherapy group |
Primary outcome
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 (%)
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)
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)
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)
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)
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)
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]
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
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor V Sergienko, MD,PHD,Prof. principal investigator
Russian National Atherosclerosis Society
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Metabolism Disorders and Cardiovascular Diseases, run by Akrikhin at 31 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of achieving target LDL (%) (time frame: at the time of enrolment in the study). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.