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

Cardiovascular Diseases Clinical Trial

— UNISON  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04895098
• Other study ID #: EZE-01/21
• Status: Completed
• Start date: June 23, 2021
• Est. completion date: July 8, 2022

Study information

• Verified date: January 2023
• Source: Akrikhin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 8, 2022
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	FGBOU VO "ChGU named after I.N. Ulianova"	Cheboksary
Russian Federation	FGBOU VO "ChGMA" Ministery of Health Russia	Chita
Russian Federation	FGBOU VO "UGMU" Ministry of Health Russia	Ekaterinburg
Russian Federation	Gbuz "Iokb"	Irkutsk
Russian Federation	Gauz "Gkb #7"	Kazan
Russian Federation	Nii "Kpssz"	Kemerovo
Russian Federation	KOGBUZ "Severnaya klinicheskaya bolnitca skoroi meditcinskoi pomotschi"	Kirov
Russian Federation	OOO TsEN YUG	Krasnodar
Russian Federation	GUZ "Lipetskaya Gorpolyklinika #7"	Lipetsk
Russian Federation	??? "MC "Semeiny doctor"	Magnitogorsk
Russian Federation	OOO "Semeiny doctor"	Magnitogorsk
Russian Federation	Chuz ''Ckb Rzhd Medicina"	Moscow
Russian Federation	FGBOU DPO RMANPO Ministry of Health	Moscow
Russian Federation	Fgbu Mnic Pm Ministry of Health Russia	Moscow
Russian Federation	FGBU NMIC of Cardiology Ministry of heath RF	Moscow
Russian Federation	OOO ''Ne bolit"	Moscow
Russian Federation	Osp Rgnkc	Moscow
Russian Federation	Gbuz No "Gkb #5"	Nizhny Novgorod
Russian Federation	GBUZ NO "Gorodskaya Klinicheskaya Bolnitsa #38"	Nizhny Novgorod
Russian Federation	OOO "DaVinchi-NN"	Nizhny Novgorod
Russian Federation	NII TPM - affiliate of SO RAN	Novosibirsk
Russian Federation	Buzoo "Kkd"	Omsk
Russian Federation	Gbus "Bsmp"	Petrozavodsk
Russian Federation	FGBOU VO SZGMU named after I.I.Mechnikov	Saint Petersburg
Russian Federation	FGBU "SZONKC named after L.G.Sokolov FMBA of Russia"	Saint Petersburg
Russian Federation	Ooo "Veraks-Med"	Saint Petersburg
Russian Federation	GBUZ "SOKKD named after V.P.Polyakov"	Samara
Russian Federation	Fgbou Vo Tyumensky Gmu Ministry of Health Russia	Tyumen
Russian Federation	Cardiology cabinet "Serdce pod zaschitoy" IP Barov P.A.	Ulyanovsk
Russian Federation	GBUZ VO "City hospital #4 of Vladimir"	Vladimir
Russian Federation	GBUZ VO "GB #4 c. Vladimir"	Vladimir

Sponsors (2)

Lead Sponsor	Collaborator
Akrikhin	Russian National Atherosclerosis Society

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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