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

NCT ID: NCT04895098

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2022-07-08

Brief 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). 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).

Conditions

Lipid Metabolism Disorders; Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

combination therapy group

750 Subjects in the statin and ezetimibe combination therapy group

statin and ezetimibe combination therapy

Intervention Type: 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.

monotherapy group

250 Subjects in the statin monotherapy group

statin monotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

no other intervention; no other intervention

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian National Atherosclerosis Society

OTHER

Sponsor Role: collaborator

Akrikhin

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Igor V Sergienko, MD,PHD,Prof.

Role: PRINCIPAL_INVESTIGATOR

Russian National Atherosclerosis Society

Locations

FGBOU VO "ChGU named after I.N. Ulianova"

Cheboksary, , Russia

FGBOU VO "ChGMA" Ministery of Health Russia

Chita, , Russia

Gbuz "Iokb"

Irkutsk, , Russia

Gauz "Gkb #7"

Kazan', , Russia

Nii "Kpssz"

Kemerovo, , Russia

KOGBUZ "Severnaya klinicheskaya bolnitca skoroi meditcinskoi pomotschi"

Kirov, , Russia

OOO TsEN YUG

Krasnodar, , Russia

GUZ "Lipetskaya Gorpolyklinika #7"

Lipetsk, , Russia

ООО "MC "Semeiny doctor"

Magnitogorsk, , Russia

OOO "Semeiny doctor"

Magnitogorsk, , Russia

Fgbu Mnic Pm Ministry of Health Russia

Moscow, , Russia

OOO ''Ne bolit"

Moscow, , Russia

FGBU NMIC of Cardiology Ministry of heath RF

Moscow, , Russia

FGBOU DPO RMANPO Ministry of Health

Moscow, , Russia

Chuz ''Ckb Rzhd Medicina"

Moscow, , Russia

Osp Rgnkc

Moscow, , Russia

GBUZ NO "Gorodskaya Klinicheskaya Bolnitsa #38"

Nizhny Novgorod, , Russia

Gbuz No "Gkb #5"

Nizhny Novgorod, , Russia

OOO "DaVinchi-NN"

Nizhny Novgorod, , Russia

NII TPM - affiliate of SO RAN

Novosibirsk, , Russia

Buzoo "Kkd"

Omsk, , Russia

Gbus "Bsmp"

Petrozavodsk, , Russia

FGBOU VO SZGMU named after I.I.Mechnikov

Saint Petersburg, , Russia

FGBU "SZONKC named after L.G.Sokolov FMBA of Russia"

Saint Petersburg, , Russia

Ooo "Veraks-Med"

Saint Petersburg, , Russia

GBUZ "SOKKD named after V.P.Polyakov"

Samara, , Russia

Fgbou Vo Tyumensky Gmu Ministry of Health Russia

Tyumen, , Russia

Cardiology cabinet "Serdce pod zaschitoy" IP Barov P.A.

Ulyanovsk, , Russia

GBUZ VO "City hospital #4 of Vladimir"

Vladimir, , Russia

GBUZ VO "GB #4 c. Vladimir"

Vladimir, , Russia

FGBOU VO "UGMU" Ministry of Health Russia

Yekaterinburg, , Russia

Countries

Russia

Other Identifiers

EZE-01/21

Identifier Type: -

Identifier Source: org_study_id