DyslipidaemiaCEPHEUSIINCT02230241
CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II (CEPHEUS II)
An observational study of Dyslipidaemia, run by AstraZeneca at 27 sites in Russia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyslipidaemia
- How many people
- 2,700 participants
- Where
- 27 sitesRussia
- Study dates
- Sep 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Russia27 sites
Research Site
Belgorod
Research Site
Berdsk
Research Site
Domodedovo
Research Site
Engel's
Research Site
Ivanovo
Research Site
Kaluga
Research Site
Kirovsk
Research Site
Korolyov
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Mytishchy
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Odintsovo
Research Site
Orenburg
Research Site
Penza
Research Site
Pushkino
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Sergiyev Posad
Research Site
Sochi
Research Site
Volgograd
Research Site
Voronezh
Research Site
Yaroslavl
Research Site
Yekaterinburg
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyslipidaemia
- Keywords
- Dyslipidaemia, LDL-C goals, Guidelines
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who reach the low-density lipoprotein cholesterol (LDL-C) goals established by the Fifth Joint European Task Force guidelines (2012).
Measured: 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
Measured: Up to 11 months
The percentage of incorrect CV-risk assessments made by physicians
Measured: 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).
Measured: Up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidaemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Bedenkov, Study director, AstraZenecaSergey Boytsov, Principal investigator, State Research Center for Preventive Medicine MoH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230241
- Sponsor's protocol ID
- NIS-CRU-XXX-2014/1
- Acronym
- CEPHEUSII
- Status last verified
- May 2016
- First submitted
- 26 Aug 2014
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29246151
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II
- ClinicalTrials.gov ID
- NCT02230241
- Acronym / sponsor ID
- CEPHEUSII / NIS-CRU-XXX-2014/1
- Conditions
- Dyslipidaemia
- Keywords
- Dyslipidaemia, LDL-C goals, Guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,700 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
The percentage of incorrect CV-risk assessments made by physicians
Time frame: 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).
Time frame: Up to 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Derived from this study: PubMed 29246151Boytsov 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.
- SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Bedenkov study director
AstraZeneca
Sergey Boytsov principal investigator
State Research Center for Preventive Medicine MoH
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidaemia, run by AstraZeneca at 27 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Up to 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02230241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.