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

NCT02230241 | Completed

• 1 other identifier: NIS-CRU-XXX-2014/1
• Study Type: observational
• Target: 2,700
• Locations: 1 country
• Sites: 27

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.

Conditions

Dyslipidaemia

Keywords

Dyslipidaemia; LDL-C goals; Guidelines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (27)

Research Site

Belgorod, Russia

Location

Research Site

Berdsk, Russia

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Domodedovo, Russia

Location

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Engel's, Russia

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Ivanovo, Russia

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Kaluga, Russia

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Kirovsk, Russia

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Korolyov, Russia

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Krasnodar, Russia

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Krasnoyarsk, Russia

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Moscow, Russia

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Mytishchy, Russia

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Nizhny Novgorod, Russia

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Novosibirsk, Russia

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Odintsovo, Russia

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Orenburg, Russia

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Penza, Russia

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Pushkino, Russia

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Rostov-on-Don, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Sergiyev Posad, Russia

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Sochi, Russia

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Volgograd, Russia

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Voronezh, Russia

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Yaroslavl, Russia

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Research Site

Yekaterinburg, Russia

Location

Related Publications (1)

• 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.

  PMID: 29246151 DERIVED

Related Links

• Synopsis

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alexander Bedenkov

  AstraZeneca

  STUDY DIRECTOR

• Sergey Boytsov

  State Research Center for Preventive Medicine MoH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: September 3, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

RU (27)