Clinical trial NCT02230241: CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II (CEPHEUS II)
Official title: CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidaemia
Keywords: Dyslipidaemia
LDL-C goals
Guidelines
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 2700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients who reach the low-density lipoprotein cholesterol (LDL-C) goals established by the Fifth Joint European Task Force guidelines (2012).
timeFrame: Up to 11 months
Secondary outcomes:
measure: The proportion of patients at moderate to very high CV risk on lipid-lowering drug therapy who reach the LDL-C goals per the Fifth Joint European Task Force guidelines in the following sub-populations
timeFrame: Up to 11 months
measure: The percentage of incorrect CV-risk assessments made by physicians
timeFrame: Up to 11 months
measure: The proportion of subjects in a subgroup of those with diabetes mellitus and interpretable Hemoglobin A1c (HbA1c) results who achieve HbA1c standardized target of 7% (per Diabetes Control and Complications Trial - DCCT1).
timeFrame: Up to 11 months
Other outcomes:
Locations:
city: Belgorod
country: Russian Federation
facility: Research Site
city: Berdsk
country: Russian Federation
facility: Research Site
city: Domodedovo
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Engels
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Kirovsk
country: Russian Federation
facility: Research Site
city: Korolev
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Mytishchy
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Odintsovo
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Pushkino
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Sergiev Posad
country: Russian Federation
facility: Research Site
city: Sochi
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Voronez
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexander Bedenkov
role: STUDY_DIRECTOR
affiliation: State Research Center for Preventive Medicine MoH
name: Sergey Boytsov
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boytsov S, Logunova N, Khomitskaya Y; CEPHEUS II investigators. Suboptimal control of lipid levels: results from the non-interventional Centralized Pan-Russian Survey of the Undertreatment of Hypercholesterolemia II (CEPHEUS II). Cardiovasc Diabetol. 2017 Dec 16;16(1):158. doi: 10.1186/s12933-017-0641-4.