<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/NCT02254668</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH_Nr. 2012-0409</org_study_id>
    <nct_id>NCT02254668</nct_id>
  </id_info>
  <brief_title>Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography</brief_title>
  <acronym>OCTandCAV</acronym>
  <official_title>Intracoronary Analysis of Cardiac Allograft Vasculopathy in Comparison to Coronary Artery Disease by Means of Optical Coherence Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized prospective multi-center imaging study which investigates the impact of different&#xD;
      immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on&#xD;
      cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness&#xD;
      will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In summary, the aim of the study is to examine the effect of the immunosuppressive agent&#xD;
      Everolimus (Certican) on the development of cardiac allograft vasculopathy (CAV).&#xD;
&#xD;
      Therefore the study is divided in three sections:&#xD;
&#xD;
      Substudy 1: Evaluation of morphological differences between between CAD and CAV.&#xD;
&#xD;
      Substudy 2: Analysis of cardiovascular risk factors (e.g. hypertension) under a specific&#xD;
      immunosuppressive protocol in patients with CAV.&#xD;
&#xD;
      Substudy 3: Prospective, randomized analysis of the influence of different immunosuppressive&#xD;
      protocols in patients with CAV.&#xD;
&#xD;
      Primary endpoint of the study will be the adaption of intimal thickness after 10 years,&#xD;
      analysed by means of optical coherence tomography.&#xD;
&#xD;
      In addition to the explanations above the most important in- and exclusion criteria are&#xD;
      listed below:&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
        -  Patients after heart transplantation&#xD;
&#xD;
        -  Patients with coronary artery disease (CAD)&#xD;
&#xD;
        -  Age 18-80 years&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
        -  Contraindication of Everolimus/Sirolimus or adjuvants&#xD;
&#xD;
        -  Renal insufficiency (Creatinine &gt; 265 µmol/l)&#xD;
&#xD;
        -  Cardiogenic shock or patients with Killip*-Class III or IV (*name)&#xD;
&#xD;
        -  Pregnant or breast feeding females&#xD;
&#xD;
        -  insufficient contraception (only for substudy 3)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intimal Thickness</measure>
    <time_frame>Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV</time_frame>
    <description>Assessment is usually performed by intracoronary angiography and endomyocardial biopsy which is routinely performed &lt;1 year after heart transplantation. Furthermore, assessment interval will be defined according to the result of these investigational procedures. If there is a diagnosis of CAV the interval will be one year, if not a follow-up examination in two years will be sufficient.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">278</enrollment>
  <condition>Intimal Proliferation</condition>
  <condition>Immunosuppression</condition>
  <arm_group>
    <arm_group_label>Everolimus (Certican®)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®). No protocol with Mycophenolate mofetil (CellCept®). Daily dosage administered depending on blood concentration (control interval 6-12 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mycophenolate mofetil (CellCept®)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®). No protocol with Everolimus (Certican®). Daily dosage administered depending on blood concentration (control interval 6-12 months)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protocol with Everolimus (Certican®)</intervention_name>
    <description>Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).</description>
    <arm_group_label>Everolimus (Certican®)</arm_group_label>
    <other_name>Randomizaiton by SecuTrial</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protocol with Mycophenolate mofetil (CellCept®)</intervention_name>
    <description>Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).</description>
    <arm_group_label>Mycophenolate mofetil (CellCept®)</arm_group_label>
    <other_name>Randomizaiton by SecuTrial</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with heart transplantation&#xD;
&#xD;
          -  Patient with coronary artery disease&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal insufficiency (&gt; 265 µmol/l)&#xD;
&#xD;
          -  Incapability to give informed consent&#xD;
&#xD;
          -  Cardiogenic shock of patient with KILLIP III or IV&#xD;
&#xD;
          -  pregnant or breast feeding females&#xD;
&#xD;
          -  insufficient contraception (only for substudy 3)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Templin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich (Switzerland), Division of Cardiology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Templin, MD, PhD</last_name>
    <phone>+41 (0)44 / 255 9585</phone>
    <email>christian.templin@usz.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Frank Ruschitzka, Professor</last_name>
    <phone>+41 (0)44 / 255 3957</phone>
    <email>frank.ruschitzka@usz.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Zurich, Division of Cardiology</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Templin, MD, PhD</last_name>
      <phone>+41 (0)44 / 255 9585</phone>
      <email>christian.templin@usz.ch</email>
    </contact>
    <contact_backup>
      <last_name>Frank Ruschitzka, Professor</last_name>
      <phone>+41 (0)44 / 255 3957</phone>
      <email>frank.ruschitzka@usz.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Christian Templin, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.octnews.org</url>
    <description>Informations about Optical Coherence Tomography (OCT)</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>December 29, 2013</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intima</keyword>
  <keyword>thickness</keyword>
  <keyword>transplantation</keyword>
  <keyword>cardiology</keyword>
  <keyword>immunosuppression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Everolimus</mesh_term>
  </intervention_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/NCT02254668
org study id: KEK-ZH_Nr. 2012-0409
nct id: NCT02254668
lead sponsor: 
collaborator: 
has dmc: Yes
Randomized prospective multi-center imaging study which investigates the impact of different
      immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on
      cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness
      will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.
In summary, the aim of the study is to examine the effect of the immunosuppressive agent
      Everolimus (Certican) on the development of cardiac allograft vasculopathy (CAV).

      Therefore the study is divided in three sections:

      Substudy 1: Evaluation of morphological differences between between CAD and CAV.

      Substudy 2: Analysis of cardiovascular risk factors (e.g. hypertension) under a specific
      immunosuppressive protocol in patients with CAV.

      Substudy 3: Prospective, randomized analysis of the influence of different immunosuppressive
      protocols in patients with CAV.

      Primary endpoint of the study will be the adaption of intimal thickness after 10 years,
      analysed by means of optical coherence tomography.

      In addition to the explanations above the most important in- and exclusion criteria are
      listed below:

      Inclusion Criteria:

        -  Patients after heart transplantation

        -  Patients with coronary artery disease (CAD)

        -  Age 18-80 years

      Exclusion Criteria:

        -  Contraindication of Everolimus/Sirolimus or adjuvants

        -  Renal insufficiency (Creatinine > 265 µmol/l)

        -  Cardiogenic shock or patients with Killip*-Class III or IV (*name)

        -  Pregnant or breast feeding females

        -  insufficient contraception (only for substudy 3)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intimal Thickness
time frame: Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV
description: Assessment is usually performed by intracoronary angiography and endomyocardial biopsy which is routinely performed <1 year after heart transplantation. Furthermore, assessment interval will be defined according to the result of these investigational procedures. If there is a diagnosis of CAV the interval will be one year, if not a follow-up examination in two years will be sufficient.
arm group label: Everolimus (Certican®)
arm group type: Experimental
description: Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®). No protocol with Mycophenolate mofetil (CellCept®). Daily dosage administered depending on blood concentration (control interval 6-12 months)
arm group label: Mycophenolate mofetil (CellCept®)
arm group type: Active Comparator
description: Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®). No protocol with Everolimus (Certican®). Daily dosage administered depending on blood concentration (control interval 6-12 months)
intervention type: Other
intervention name: Protocol with Everolimus (Certican®)
description: Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).
arm group label: Everolimus (Certican®)
other name: Randomizaiton by SecuTrial
intervention type: Other
intervention name: Protocol with Mycophenolate mofetil (CellCept®)
description: Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).
arm group label: Mycophenolate mofetil (CellCept®)
other name: Randomizaiton by SecuTrial
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Christian Templin, MD, PhD
role: Principal Investigator
affiliation: University Hospital Zurich (Switzerland), Division of Cardiology
last name: Christian Templin, MD, PhD
phone: +41 (0)44 / 255 9585
email: christian.templin@usz.ch
last name: Frank Ruschitzka, Professor
phone: +41 (0)44 / 255 3957
email: frank.ruschitzka@usz.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Switzerland
url: http://www.octnews.org
description: Informations about Optical Coherence Tomography (OCT)
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Mycophenolic Acid
mesh term: Everolimus