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

NCT04895098 | Completed

• 1 other identifier: EZE-01/21
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 31

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

Keywords

Ezetimibе; Statin; Cardiovascular diseases; Lipid-lowering therapy

Outcome Measures

Primary Outcomes (9)

• Frequency of achieving target LDL (%)

  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)

  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)

  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)

  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)

  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)

  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

  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

  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

  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

Study Arms (2)

combination therapy group

750 Subjects in the statin and ezetimibe combination therapy group

Drug: statin and ezetimibe combination therapy

monotherapy group

250 Subjects in the statin monotherapy group

Drug: statin monotherapy

Interventions

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.

Also known as: no other intervention

combination therapy group

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.

Also known as: no other intervention

monotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Akrikhin: lead
• Russian National Atherosclerosis Society: collaborator

Study Sites (31)

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

Cheboksary, 428015, Russia

Location

FGBOU VO "ChGMA" Ministery of Health Russia

Chita, 672000, Russia

Location

Gbuz "Iokb"

Irkutsk, 664049, Russia

Location

Gauz "Gkb #7"

Kazan', 420103, Russia

Location

Nii "Kpssz"

Kemerovo, 650002, Russia

Location

KOGBUZ "Severnaya klinicheskaya bolnitca skoroi meditcinskoi pomotschi"

Kirov, 610011, Russia

Location

OOO TsEN YUG

Krasnodar, 350004, Russia

Location

GUZ "Lipetskaya Gorpolyklinika #7"

Lipetsk, 398004, Russia

Location

ООО "MC "Semeiny doctor"

Magnitogorsk, 455034, Russia

Location

OOO "Semeiny doctor"

Magnitogorsk, 455044, Russia

Location

Fgbu Mnic Pm Ministry of Health Russia

Moscow, 101000, Russia

Location

OOO ''Ne bolit"

Moscow, 119296, Russia

Location

FGBU NMIC of Cardiology Ministry of heath RF

Moscow, 121552, Russia

Location

FGBOU DPO RMANPO Ministry of Health

Moscow, 125993, Russia

Location

Chuz ''Ckb Rzhd Medicina"

Moscow, 129128, Russia

Location

Osp Rgnkc

Moscow, 129226, Russia

Location

GBUZ NO "Gorodskaya Klinicheskaya Bolnitsa #38"

Nizhny Novgorod, 603000, Russia

Location

Gbuz No "Gkb #5"

Nizhny Novgorod, 603005, Russia

Location

OOO "DaVinchi-NN"

Nizhny Novgorod, 603022, Russia

Location

NII TPM - affiliate of SO RAN

Novosibirsk, 630089, Russia

Location

Buzoo "Kkd"

Omsk, 644024, Russia

Location

Gbus "Bsmp"

Petrozavodsk, 185031, Russia

Location

FGBOU VO SZGMU named after I.I.Mechnikov

Saint Petersburg, 191015, Russia

Location

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

Saint Petersburg, 194291, Russia

Location

Ooo "Veraks-Med"

Saint Petersburg, 195267, Russia

Location

GBUZ "SOKKD named after V.P.Polyakov"

Samara, 443070, Russia

Location

Fgbou Vo Tyumensky Gmu Ministry of Health Russia

Tyumen, 625023, Russia

Location

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

Ulyanovsk, 432071, Russia

Location

GBUZ VO "City hospital #4 of Vladimir"

Vladimir, 600020, Russia

Location

GBUZ VO "GB #4 c. Vladimir"

Vladimir, 600020, Russia

Location

FGBOU VO "UGMU" Ministry of Health Russia

Yekaterinburg, 620028, Russia

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders; Cardiovascular Diseases

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Igor V Sergienko, MD,PHD,Prof.

  Russian National Atherosclerosis Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: June 23, 2021
• Primary Completion: November 25, 2021
• Study Completion: July 8, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (31)