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

CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidaemia

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.

• Study Type: Observational
• Enrollment (Actual): 2700

Contacts and Locations

Study Locations

• Russian Federation
  • Belgorod, Russian Federation
    • Research Site
  • Berdsk, Russian Federation
    • Research Site
  • Domodedovo, Russian Federation
    • Research Site
  • Ekaterinburg, Russian Federation
    • Research Site
  • Engels, Russian Federation
    • Research Site
  • Ivanovo, Russian Federation
    • Research Site
  • Kaluga, Russian Federation
    • Research Site
  • Kirovsk, Russian Federation
    • Research Site
  • Korolev, Russian Federation
    • Research Site
  • Krasnodar, Russian Federation
    • Research Site
  • Krasnoyarsk, Russian Federation
    • Research Site
  • Moscow, Russian Federation
    • Research Site
  • Mytishchy, Russian Federation
    • Research Site
  • Nizhny Novgorod, Russian Federation
    • Research Site
  • Novosibirsk, Russian Federation
    • Research Site
  • Odintsovo, Russian Federation
    • Research Site
  • Orenburg, Russian Federation
    • Research Site
  • Penza, Russian Federation
    • Research Site
  • Pushkino, Russian Federation
    • Research Site
  • Rostov-on-Don, Russian Federation
    • Research Site
  • Samara, Russian Federation
    • Research Site
  • Sergiev Posad, Russian Federation
    • Research Site
  • Sochi, Russian Federation
    • Research Site
  • St.Petersburg, Russian Federation
    • Research Site
  • Volgograd, Russian Federation
    • Research Site
  • Voronez, Russian Federation
    • Research Site
  • Yaroslavl, Russian Federation
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients who reach the low-density lipoprotein cholesterol (LDL-C) goals established by the Fifth Joint European Task Force guidelines (2012).	Up to 11 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Up to 11 months
The percentage of incorrect CV-risk assessments made by physicians	Up to 11 months
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).	Up to 11 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Alexander Bedenkov, AstraZeneca; Principal Investigator: Sergey Boytsov, State Research Center for Preventive Medicine MoH

Publications and helpful links

General Publications

• 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.

Helpful Links

• Synopsis

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 3, 2014

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Guidelines; Dyslipidaemia; LDL-C goals
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: NIS-CRU-XXX-2014/1