Clinical trial NCT04895098: Statin Monotherapy or Statins in Combination With Ezetimibe in Patients for Prevention of CVD
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipid Metabolism Disorders
Cardiovascular Diseases
Keywords: Ezetimibе
Statin
Cardiovascular diseases
Lipid-lowering therapy
Lead sponsor: Akrikhin
Sponsor class: INDUSTRY
Collaborators: name: Russian National Atherosclerosis Society
First posted: 2021-05-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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).


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

Primary outcomes:
measure: Frequency of achieving target LDL (%)
timeFrame: at the time of enrolment in the study
measure: Average change in LDL (absolute difference)
timeFrame: 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
measure: Average change in LDL (% from the baseline)
timeFrame: 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
measure: Average change in total cholesterol (% and absolute difference)
timeFrame: 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
measure: Average change in LDL (% and absolute difference)
timeFrame: 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
measure: Average change in TG (% and absolute difference)
timeFrame: 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
measure: The incidence of liver damage
timeFrame: 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
measure: The frequency of development of muscle damage
timeFrame: 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
measure: Major adverse cardiovascular events (MACE) incidence
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Cheboksary
country: Russian Federation
facility: FGBOU VO "ChGU named after I.N. Ulianova"
city: Chita
country: Russian Federation
facility: FGBOU VO "ChGMA" Ministery of Health Russia
city: Ekaterinburg
country: Russian Federation
facility: FGBOU VO "UGMU" Ministry of Health Russia
city: Irkutsk
country: Russian Federation
facility: Gbuz "Iokb"
city: Kazan
country: Russian Federation
facility: Gauz "Gkb #7"
city: Kemerovo
country: Russian Federation
facility: Nii "Kpssz"
city: Kirov
country: Russian Federation
facility: KOGBUZ "Severnaya klinicheskaya bolnitca skoroi meditcinskoi pomotschi"
city: Krasnodar
country: Russian Federation
facility: OOO TsEN YUG
city: Lipetsk
country: Russian Federation
facility: GUZ "Lipetskaya Gorpolyklinika #7"
city: Magnitogorsk
country: Russian Federation
facility: ООО "MC "Semeiny doctor"
city: Magnitogorsk
country: Russian Federation
facility: OOO "Semeiny doctor"
city: Moscow
country: Russian Federation
facility: Fgbu Mnic Pm Ministry of Health Russia
city: Moscow
country: Russian Federation
facility: OOO ''Ne bolit"
city: Moscow
country: Russian Federation
facility: FGBU NMIC of Cardiology Ministry of heath RF
city: Moscow
country: Russian Federation
facility: FGBOU DPO RMANPO Ministry of Health
city: Moscow
country: Russian Federation
facility: Chuz ''Ckb Rzhd Medicina"
city: Moscow
country: Russian Federation
facility: Osp Rgnkc
city: Nizhny Novgorod
country: Russian Federation
facility: GBUZ NO "Gorodskaya Klinicheskaya Bolnitsa #38"
city: Nizhny Novgorod
country: Russian Federation
facility: Gbuz No "Gkb #5"
city: Nizhny Novgorod
country: Russian Federation
facility: OOO "DaVinchi-NN"
city: Novosibirsk
country: Russian Federation
facility: NII TPM - affiliate of SO RAN
city: Omsk
country: Russian Federation
facility: Buzoo "Kkd"
city: Petrozavodsk
country: Russian Federation
facility: Gbus "Bsmp"
city: Saint Petersburg
country: Russian Federation
facility: FGBOU VO SZGMU named after I.I.Mechnikov
city: Saint Petersburg
country: Russian Federation
facility: FGBU "SZONKC named after L.G.Sokolov FMBA of Russia"
city: Saint Petersburg
country: Russian Federation
facility: Ooo "Veraks-Med"
city: Samara
country: Russian Federation
facility: GBUZ "SOKKD named after V.P.Polyakov"
city: Tyumen
country: Russian Federation
facility: Fgbou Vo Tyumensky Gmu Ministry of Health Russia
city: Ulyanovsk
country: Russian Federation
facility: Cardiology cabinet "Serdce pod zaschitoy" IP Barov P.A.
city: Vladimir
country: Russian Federation
facility: GBUZ VO "City hospital #4 of Vladimir"
city: Vladimir
country: Russian Federation
facility: GBUZ VO "GB #4 c. Vladimir"
Study officials:
affiliation: Russian National Atherosclerosis Society
name: Igor V Sergienko, MD,PHD,Prof.
role: PRINCIPAL_INVESTIGATOR
References: