<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/NCT02190123</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-CBE-XXX-2014/1</org_study_id>
    <nct_id>NCT02190123</nct_id>
  </id_info>
  <brief_title>REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR &amp; Other Oral Antiplatelets (OAP) in Patients With Acute Coronary Syndrome (ACS) in Be/Lux.</brief_title>
  <acronym>REWINDER</acronym>
  <official_title>REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR &amp; Other Oral Antiplatelets in Patients With Acute Coronary Syndrome in Belgium/Luxembourg (REWINDER)</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>
      REWINDER is a multinational, multicentre, non-interventional, retrospective study of patients&#xD;
      treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in hospital&#xD;
      after an acute coronary syndrome (ACS) event, to be conducted in Belgium and Luxembourg.&#xD;
&#xD;
      Primary objective is to evaluate the actual treatment persistence with oral antiplatelets&#xD;
      (OAP) after an ACS in the clinical practice in Belgium and Luxembourg.&#xD;
&#xD;
      The main secondary objectives are to describe the most frequent reasons for OAP treatment&#xD;
      switch, discontinuation or reinitiation; to identify the decisionmakers in the OAP treatment&#xD;
      changes and to characterize the patient profile in terms of demographics, diagnosis,&#xD;
      management strategies, comorbidities and concomitant medications to identify any association&#xD;
      between patient profile and treatment duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment of acute coronary syndrome (ACS) with oral antiplatelets (OAPs) is recommended for&#xD;
      up to 12 months unless discontinuation is clinically indicated. Early discontinuation could&#xD;
      result in an increased risk of cardiovascular death or myocardial infarction due to the&#xD;
      patient's underlying disease.&#xD;
&#xD;
      There are no robust data allowing to evaluate the treatment persistence with OAPs after ACS&#xD;
      in the current practice in Belgium and Luxembourg at this time. It is currently unclear as to&#xD;
      why patients discontinue, switch or reinitiate treatment and upon whose advice. A&#xD;
      non-interventional study is needed to obtain reliable data on treatment persistence and&#xD;
      reasons for discontinuation, switch or reinitiation of treatment.&#xD;
&#xD;
      REWINDER is a multinational, multicentre, non-interventional, retrospective study of patients&#xD;
      treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in hospital&#xD;
      after an ACS event, to be conducted in Belgium and Luxembourg. Primary objective is to&#xD;
      evaluate the actual treatment persistence with OAPs after an ACS in the clinical practice in&#xD;
      Belgium and Luxembourg. The main secondary objectives are to describe the most frequent&#xD;
      reasons for OAP treatment switch, discontinuation or reinitiation; to identify the&#xD;
      decisionmakers in the OAP treatment changes and to characterize the patient profile in terms&#xD;
      of demographics, diagnosis, management strategies, comorbidities and concomitant medications&#xD;
      to identify any association between patient profile and treatment duration.&#xD;
&#xD;
      The target sample size of the study is 500 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>The actual treatment persistence with OAP after an ACS in the clinical practice of Belgium and Luxembourg will be assessed by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. Number and proportion of patients having stopped treatment after 1, 3, 6, 9 &amp; 12 month will be assessed and described.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The reasons for OAP treatment switch, discontinuation or re-initiation will be assessed by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. The reasons for switch, discontinuation &amp; re-initiation (side-effects, drug-drug interactions, cost of treatment, patient's complaint, high bleeding risk &amp; other) will be assessed and described.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The decisionmakers in the oral antiplatelet (OAP) treatment changes will be identified by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. The decisionmakers will be identified and described (cardiologist interventional, cardiologist non interventional, surgeon, other specialist, dentist, GP, patient and/or family, other).</description>
  </other_outcome>
  <other_outcome>
    <measure>The patient profile will be characterized by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. Patient profile will be described in terms of demographics, diagnosis, management strategies, comorbidities and concomitant medications to identify any association between patient profile and treatment duration.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">430</enrollment>
  <condition>Treatment of Acute Coronary Syndrome (ACS).</condition>
  <arm_group>
    <arm_group_label>ACS patients treated with OAP</arm_group_label>
    <description>Patients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACS patients treated with OAP</intervention_name>
    <description>Patients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets.</description>
    <arm_group_label>ACS patients treated with OAP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female patients from Belgium and Luxembourg, aged 18 years or more , discharged&#xD;
        alive from hospital to home following an acute coronary syndrome (ACS) and who were treated&#xD;
        with an oral antiplatelet (OAP) (ticagrelor, prasugrel or clopidogrel) after an acute&#xD;
        coronary syndrome (ACS) event (Unstable Angina (UA), ST-elevation myocardial infarction&#xD;
        (STEMI) or non-STEMI(NSTEMI)).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The patient population that will be observed in the NIS must fulfil all of the following&#xD;
        criteria:&#xD;
&#xD;
          1. Female or male aged ≥18 years&#xD;
&#xD;
          2. A patient information letter has been sent by the Investigator to the patient&#xD;
&#xD;
          3. Patient discharged alive from this hospital to home following ACS (diagnosed with&#xD;
             STEMI, NSTEMI or UA)&#xD;
&#xD;
          4. ACS is either UA or myocardial infarction of Type 1 (spontaneous myocardial infarction&#xD;
             related to ischemia due to a primary coronary event such as plaque erosion and/or&#xD;
             rupture, fissuring, or dissection)&#xD;
&#xD;
          5. ACS after 1st July 2012 and before 1st June 2013&#xD;
&#xD;
          6. Patient on ticagrelor, prasugrel or clopidogrel treatment at discharge following an&#xD;
             ACS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will not be eligible to participate if any of the following exclusion criteria are&#xD;
        present:&#xD;
&#xD;
          1. Patient who participated in any interventional clinical study during the observation&#xD;
             period.&#xD;
&#xD;
          2. Patient with ACS precipitated by or as complication of surgery, trauma,&#xD;
             gastrointestinal bleeding or after Percutaneous Coronary Intervention (PCI)&#xD;
&#xD;
          3. Patient with ACS occurring during a stay in the hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Claeys, Prof Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Antwerpen (UZA)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baudour</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bonheiden</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brasschaat</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brugge</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charleroi</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liege</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mechelen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montegnee</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ronse</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ukkel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=3037&amp;filename=Synopsis.pdf</url>
    <description>Synopsis</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>January 7, 2016</last_update_submitted>
  <last_update_submitted_qc>January 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Coronary Syndrome (ACS)</keyword>
  <keyword>Oral antiplatelets (ticagrelor, prasugrel, clopidogrel) (OAP)</keyword>
  <keyword>Treatment persistence.</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>
  <!-- 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/NCT02190123
org study id: NIS-CBE-XXX-2014/1
nct id: NCT02190123
lead sponsor: 
has dmc: No
REWINDER is a multinational, multicentre, non-interventional, retrospective study of patients
      treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in hospital
      after an acute coronary syndrome (ACS) event, to be conducted in Belgium and Luxembourg.

      Primary objective is to evaluate the actual treatment persistence with oral antiplatelets
      (OAP) after an ACS in the clinical practice in Belgium and Luxembourg.

      The main secondary objectives are to describe the most frequent reasons for OAP treatment
      switch, discontinuation or reinitiation; to identify the decisionmakers in the OAP treatment
      changes and to characterize the patient profile in terms of demographics, diagnosis,
      management strategies, comorbidities and concomitant medications to identify any association
      between patient profile and treatment duration.
Treatment of acute coronary syndrome (ACS) with oral antiplatelets (OAPs) is recommended for
      up to 12 months unless discontinuation is clinically indicated. Early discontinuation could
      result in an increased risk of cardiovascular death or myocardial infarction due to the
      patient's underlying disease.

      There are no robust data allowing to evaluate the treatment persistence with OAPs after ACS
      in the current practice in Belgium and Luxembourg at this time. It is currently unclear as to
      why patients discontinue, switch or reinitiate treatment and upon whose advice. A
      non-interventional study is needed to obtain reliable data on treatment persistence and
      reasons for discontinuation, switch or reinitiation of treatment.

      REWINDER is a multinational, multicentre, non-interventional, retrospective study of patients
      treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in hospital
      after an ACS event, to be conducted in Belgium and Luxembourg. Primary objective is to
      evaluate the actual treatment persistence with OAPs after an ACS in the clinical practice in
      Belgium and Luxembourg. The main secondary objectives are to describe the most frequent
      reasons for OAP treatment switch, discontinuation or reinitiation; to identify the
      decisionmakers in the OAP treatment changes and to characterize the patient profile in terms
      of demographics, diagnosis, management strategies, comorbidities and concomitant medications
      to identify any association between patient profile and treatment duration.

      The target sample size of the study is 500 patients.
observational model: Case-Only
time perspective: Retrospective
measure: The actual treatment persistence with OAP after an ACS in the clinical practice of Belgium and Luxembourg will be assessed by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.
time frame: up to 1 year
description: Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. Number and proportion of patients having stopped treatment after 1, 3, 6, 9 & 12 month will be assessed and described.
measure: The reasons for OAP treatment switch, discontinuation or re-initiation will be assessed by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.
time frame: up to 1 year
description: Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. The reasons for switch, discontinuation & re-initiation (side-effects, drug-drug interactions, cost of treatment, patient's complaint, high bleeding risk & other) will be assessed and described.
measure: The decisionmakers in the oral antiplatelet (OAP) treatment changes will be identified by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.
time frame: up to 1 year
description: Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. The decisionmakers will be identified and described (cardiologist interventional, cardiologist non interventional, surgeon, other specialist, dentist, GP, patient and/or family, other).
measure: The patient profile will be characterized by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.
time frame: up to 1 year
description: Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. Patient profile will be described in terms of demographics, diagnosis, management strategies, comorbidities and concomitant medications to identify any association between patient profile and treatment duration.
arm group label: ACS patients treated with OAP
description: Patients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets
intervention type: Drug
intervention name: ACS patients treated with OAP
description: Patients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets.
arm group label: ACS patients treated with OAP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Marc Claeys, Prof Dr
role: Principal Investigator
affiliation: Universitair Ziekenhuis Antwerpen (UZA)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Belgium
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3037&filename=Synopsis.pdf
description: Synopsis
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome