Status:
COMPLETED
Statin Monotherapy or Statins in Combination With Ezetimibe in Patients for Prevention of CVD
Lead Sponsor:
Akrikhin
Collaborating Sponsors:
Russian National Atherosclerosis Society
Conditions:
Lipid Metabolism Disorders
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04895098
Start Date
June 23 2021
End Date
July 8 2022
Last Update
January 12 2023
Active Locations (31)
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1
FGBOU VO "ChGU named after I.N. Ulianova"
Cheboksary, Russia, 428015
2
FGBOU VO "ChGMA" Ministery of Health Russia
Chita, Russia, 672000
3
Gbuz "Iokb"
Irkutsk, Russia, 664049
4
Gauz "Gkb #7"
Kazan', Russia, 420103