<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02230241</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-CRU-XXX-2014/1</org_study_id>
    <nct_id>NCT02230241</nct_id>
  </id_info>
  <brief_title>CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II (CEPHEUS II)</brief_title>
  <acronym>CEPHEUSII</acronym>
  <official_title>CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center survey of patients who are currently receiving lipid-lowering&#xD;
      medications and have a moderate or higher cardiovascular (CV) risk. The survey will be&#xD;
      conducted in the Russian Federation. Data collection for each study subject will be done&#xD;
      within one physician visit. If an enrolled subject comes to the visit not fasting (for at&#xD;
      least 8 hours), an appointment for the blood tests will be made for another day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center survey of patients who are currently receiving lipid-lowering&#xD;
      medications and have a moderate or higher CV risk. The survey will be conducted in the&#xD;
      Russian Federation.&#xD;
&#xD;
      Data collection for each study subject will be done within one physician visit. If an&#xD;
      enrolled subject comes to the visit not fasting (for at least 8 hours), an appointment for&#xD;
      the blood tests will be made for another day.&#xD;
&#xD;
      Prior to the assessment of the first subject at a site, each investigator will complete an&#xD;
      investigator questionnaire on his/her experience and perception of the management of&#xD;
      hypercholesterolemia in his/her patients.&#xD;
&#xD;
      Prior to the assessment, subjects will record on a patient questionnaire their awareness of&#xD;
      hypercholesterolemia, their current treatment schedule, their perception, and compliance.&#xD;
&#xD;
      The investigator will complete a Case Report Form (CRF) with the subject's demographics,&#xD;
      known cardiovascular risk factors, cardiovascular medical history, current lipid-lowering&#xD;
      drug therapy, and the reason for this therapy.&#xD;
&#xD;
      Fasting blood samples will be taken in tubes to test for total cholesterol, low-density&#xD;
      lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), glucose,&#xD;
      creatinine, hemoglobin A1c, hemoglobin, and hematocrit at a central laboratory in the Russian&#xD;
      Federation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <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).</measure>
    <time_frame>Up to 11 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Up to 11 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of incorrect CV-risk assessments made by physicians</measure>
    <time_frame>Up to 11 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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).</measure>
    <time_frame>Up to 11 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2700</enrollment>
  <condition>Dyslipidaemia</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>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>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects of either gender and any race, aged ≥ 18 years, at moderate to very high CV risk,&#xD;
        on lipid-lowering pharmacotherapy for at least 3 months (90 days), with no dose change for&#xD;
        a minimum of 8 weeks (56 days). Before starting any study-related activities, the&#xD;
        investigator should obtain written informed consent personally signed and dated by the&#xD;
        subject.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Properly obtained written informed consent from the potential subject.&#xD;
&#xD;
          -  On lipid-lowering drug therapy for at least 3 months (90 days), with no dose change&#xD;
             for a minimum of 8 weeks (56 days).&#xD;
&#xD;
          -  Scheduled blood tests for total cholesterol (TC), HDL-C, LDL-C, glucose, creatinine,&#xD;
             HbA1c, Hb, and hematocrit on the visit when they are considered for survey&#xD;
             participation, or these tests must be decided to be necessary for study-unrelated&#xD;
             purposes during that visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are unwilling or unable to provide written informed consent.&#xD;
&#xD;
          -  The cognitive status of a potential subject and/or their home environment (in the&#xD;
             investigator's opinion) might compromise the compliance with the treatment regimen&#xD;
             during the past 8 weeks.&#xD;
&#xD;
          -  A low CV risk.&#xD;
&#xD;
          -  Participating in any other clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Bedenkov</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergey Boytsov</last_name>
    <role>Principal Investigator</role>
    <affiliation>State Research Center for Preventive Medicine MoH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Belgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berdsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Domodedovo</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Engels</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ivanovo</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kaluga</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kirovsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Korolev</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Krasnodar</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Krasnoyarsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mytishchy</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nizhny Novgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Odintsovo</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orenburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Penza</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pushkino</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rostov-on-Don</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Samara</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sergiev Posad</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sochi</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St.Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Volgograd</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Voronez</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=3105&amp;filename=CEPHEUSII_NISPrimaryReport_Synopsis.pdf</url>
    <description>Synopsis</description>
  </link>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>May 4, 2016</last_update_submitted>
  <last_update_submitted_qc>May 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dyslipidaemia</keyword>
  <keyword>LDL-C goals</keyword>
  <keyword>Guidelines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02230241
org study id: NIS-CRU-XXX-2014/1
nct id: NCT02230241
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
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
measure: 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
measure: The percentage of incorrect CV-risk assessments made by physicians
time frame: Up to 11 months
measure: 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
arm group label: Cohort 1
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alexander Bedenkov
role: Study Director
affiliation: AstraZeneca
last name: Sergey Boytsov
role: Principal Investigator
affiliation: State Research Center for Preventive Medicine MoH
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country: Russian Federation
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3105&filename=CEPHEUSII_NISPrimaryReport_Synopsis.pdf
description: Synopsis
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Dyslipidemias