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

Dyslipidaemia Clinical Trial

— CEPHEUSII  

Official title:

CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230241
• Other study ID #: NIS-CRU-XXX-2014/1
• Status: Completed
• Phase: N/A
• First received: August 26, 2014
• Last updated: May 4, 2016
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Independent Interdisciplinary Committee of ethical review of clinical trials
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2700
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyslipidaemia
• Dyslipidemias
• Hypercholesterolemia

Locations

Country	Name	City	State
Russian Federation	Research Site	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	The percentage of incorrect CV-risk assessments made by physicians		Up to 11 months	No
Secondary	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	No

External Links

•   Synopsis