CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II (CEPHEUS II) (CEPHEUSII)

AstraZeneca

Status: Completed

Conditions: Dyslipidaemia

Study type: Observational

Funder types: Industry

Identifiers

NCT02230241

NIS-CRU-XXX-2014/1

Details and patient eligibility

About

This is a multi-center survey of patients who are currently receiving lipid-lowering medications and have a moderate or higher cardiovascular (CV) risk. The survey will be conducted in the Russian Federation. Data collection for each study subject will be done within one physician visit. If an enrolled subject comes to the visit not fasting (for at least 8 hours), an appointment for the blood tests will be made for another day.

Full description

This is a multi-center survey of patients who are currently receiving lipid-lowering medications and have a moderate or higher CV risk. The survey will be conducted in the Russian Federation.

Data collection for each study subject will be done within one physician visit. If an enrolled subject comes to the visit not fasting (for at least 8 hours), an appointment for the blood tests will be made for another day.

Prior to the assessment of the first subject at a site, each investigator will complete an investigator questionnaire on his/her experience and perception of the management of hypercholesterolemia in his/her patients.

Prior to the assessment, subjects will record on a patient questionnaire their awareness of hypercholesterolemia, their current treatment schedule, their perception, and compliance.

The investigator will complete a Case Report Form (CRF) with the subject's demographics, known cardiovascular risk factors, cardiovascular medical history, current lipid-lowering drug therapy, and the reason for this therapy.

Fasting blood samples will be taken in tubes to test for total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), glucose, creatinine, hemoglobin A1c, hemoglobin, and hematocrit at a central laboratory in the Russian Federation.

Enrollment: 2,700 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Properly obtained written informed consent from the potential subject.
• On lipid-lowering drug therapy for at least 3 months (90 days), with no dose change for a minimum of 8 weeks (56 days).
• Scheduled blood tests for total cholesterol (TC), HDL-C, LDL-C, glucose, creatinine, HbA1c, Hb, and hematocrit on the visit when they are considered for survey participation, or these tests must be decided to be necessary for study-unrelated purposes during that visit.

Exclusion criteria

• Subjects who are unwilling or unable to provide written informed consent.
• The cognitive status of a potential subject and/or their home environment (in the investigator's opinion) might compromise the compliance with the treatment regimen during the past 8 weeks.
• A low CV risk.
• Participating in any other clinical trial.

Trial design

2,700 participants in 1 patient group

Cohort 1

Description:

Subjects of either gender and any race, aged ≥ 18 years, at moderate to very high CV risk, on lipid-lowering pharmacotherapy for at least 3 months (90 days), with no dose change for a minimum of 8 weeks (56 days). Before starting any study-related activities, the investigator should obtain written informed consent personally signed and dated by the subject.