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NCT Number: NCT02230241

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Belgorod, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

    Time frame: Up to 11 months

Secondary outcomes

  1. 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

    Time frame: Up to 11 months

  2. The percentage of incorrect CV-risk assessments made by physicians

    Time frame: Up to 11 months

  3. 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).

    Time frame: Up to 11 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II

Acronym: CEPHEUSII

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 3, 2014
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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