<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/NCT02265068</url>
  </required_header>
  <id_info>
    <org_study_id>Real-TICA</org_study_id>
    <nct_id>NCT02265068</nct_id>
  </id_info>
  <brief_title>Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes</brief_title>
  <acronym>Real-TICA</acronym>
  <official_title>Real-TICA Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes. Evaluation of Antiplatelet Therapy After 12 Months in Patients Undergoing PCI and Treated With Ticagrelor During the Acute Phase of an ACS.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IHF GmbH - Institut für Herzinfarktforschung</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IHF GmbH - Institut für Herzinfarktforschung</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Documentation of long-term data regarding ticagrelor use and evaluation of reasons for&#xD;
      discontinuation of ticagrelor in patients with ACS&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      REAL-TICA is a retrospective non-interventional study to assess the long-term use of&#xD;
      ticagrelor in patients with ACS and to evaluate the reasons for discontinuation of&#xD;
      ticagrelor.&#xD;
&#xD;
      For this purpose, selected sites from the ALKK-PCI registry and the respective patients will&#xD;
      be identified. The sites' eligibility for this study includes the frequent use of ticagrelor&#xD;
      during the acute phase of ACS. Eligible patients are characterised by the diagnosis of ACS&#xD;
      and the use of ticagrelor during PCI.&#xD;
&#xD;
      The eligible sites will be contacted by IHF and asked to contact their eligible patients by&#xD;
      letter to obtain informed consent of the patients for the planned 12M follow-up by IHF. A&#xD;
      detailed questionnaire on events within the last 12 months, current symptoms, current&#xD;
      medication and the use of ticagrelor will be added to the patients' letters. Patients then&#xD;
      are asked to return their responses on consent to participate in the study as well as the&#xD;
      filled in questionnaire to IHF. Alternatively, patients may choose to receive a telephone&#xD;
      call by IHF to answer the detailed questionnaire in person. In case of essential information&#xD;
      missing, IHF will contact the primary care physician of the patient directly to obtain&#xD;
      information about clinical events and medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment outcomes of ACS patients receiving Ticagrelor</measure>
    <time_frame>12 months</time_frame>
    <description>Documentation of Events for ACS patients treated with Ticagrelor with follow-up over 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long-term use and premature discontinuation of Ticagrelor treatment</measure>
    <time_frame>12 months</time_frame>
    <description>Documentation of time span during which Ticagrelor is taken by patient</description>
  </secondary_outcome>
  <enrollment type="Actual">700</enrollment>
  <condition>Acute Coronary Syndrome (ACS)</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor</intervention_name>
    <description>Treatment of ACS patients with Ticagrelor</description>
    <other_name>Anti-platelet therapy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients from the ALKK-PCI registry discharged alive after PCI for ACS (STEMI and&#xD;
        NSTE-ACS) and treated with ticagrelor during the acute phase.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  ACS (STEMI or NSTE-ACS) with PCI&#xD;
&#xD;
          -  Ticagrelor treatment during the acute phase&#xD;
&#xD;
          -  Written informed consent for participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uwe Zeymer, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum Ludwigshafen, Stiftung IHF - Institut für Herzinfarktforschung</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zentralklinik Bad Berka GmbH</name>
      <address>
        <city>Bad Berka</city>
        <zip>99437</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes-Klinikum Neukölln</name>
      <address>
        <city>Berlin</city>
        <zip>12351</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Hildesheim GmbH</name>
      <address>
        <city>Hildesheim</city>
        <zip>31135</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Landshut-Achdorf</name>
      <address>
        <city>Landshut</city>
        <zip>84036</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Ludwigshafen</name>
      <address>
        <city>Ludwigshafen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum-Wetzlar Braunsfeld</name>
      <address>
        <city>Wetzlar</city>
        <zip>35578</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Zeymer U, Cully M, Hochadel M. Adherence to dual antiplatelet therapy with ticagrelor in patients with acute coronary syndromes treated with percutaneous coronary intervention in real life. Results of the REAL-TICA registry. Eur Heart J Cardiovasc Pharmacother. 2018 Oct 1;4(4):205-210. doi: 10.1093/ehjcvp/pvy018.</citation>
    <PMID>29878086</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute coronary syndrome (ACS), Ticagrelor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ticagrelor</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/NCT02265068
org study id: Real-TICA
nct id: NCT02265068
lead sponsor: 
has dmc: No
Documentation of long-term data regarding ticagrelor use and evaluation of reasons for
      discontinuation of ticagrelor in patients with ACS
REAL-TICA is a retrospective non-interventional study to assess the long-term use of
      ticagrelor in patients with ACS and to evaluate the reasons for discontinuation of
      ticagrelor.

      For this purpose, selected sites from the ALKK-PCI registry and the respective patients will
      be identified. The sites' eligibility for this study includes the frequent use of ticagrelor
      during the acute phase of ACS. Eligible patients are characterised by the diagnosis of ACS
      and the use of ticagrelor during PCI.

      The eligible sites will be contacted by IHF and asked to contact their eligible patients by
      letter to obtain informed consent of the patients for the planned 12M follow-up by IHF. A
      detailed questionnaire on events within the last 12 months, current symptoms, current
      medication and the use of ticagrelor will be added to the patients' letters. Patients then
      are asked to return their responses on consent to participate in the study as well as the
      filled in questionnaire to IHF. Alternatively, patients may choose to receive a telephone
      call by IHF to answer the detailed questionnaire in person. In case of essential information
      missing, IHF will contact the primary care physician of the patient directly to obtain
      information about clinical events and medications.
observational model: Case-Only
time perspective: Retrospective
measure: Treatment outcomes of ACS patients receiving Ticagrelor
time frame: 12 months
description: Documentation of Events for ACS patients treated with Ticagrelor with follow-up over 12 months
measure: Long-term use and premature discontinuation of Ticagrelor treatment
time frame: 12 months
description: Documentation of time span during which Ticagrelor is taken by patient
intervention type: Drug
intervention name: Ticagrelor
description: Treatment of ACS patients with Ticagrelor
other name: Anti-platelet therapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Uwe Zeymer, Prof. Dr.
role: Principal Investigator
affiliation: Klinikum Ludwigshafen, Stiftung IHF - Institut für Herzinfarktforschung
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
citation: Zeymer U, Cully M, Hochadel M. Adherence to dual antiplatelet therapy with ticagrelor in patients with acute coronary syndromes treated with percutaneous coronary intervention in real life. Results of the REAL-TICA registry. Eur Heart J Cardiovasc Pharmacother. 2018 Oct 1;4(4):205-210. doi: 10.1093/ehjcvp/pvy018.
PMID: 29878086
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Ticagrelor