NCT04895098

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Akrikhin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-06-23
• Primary completion: 2021-11-25
• Completion: 2022-07-08
• First posted: 2021-05-20
• Last updated: 2023-01-12

Locations

31 sites across 1 country: Russia