<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/NCT01678339</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-CIT-XXX-2012/1</org_study_id>
    <nct_id>NCT01678339</nct_id>
  </id_info>
  <brief_title>Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients</brief_title>
  <acronym>HEALTH-DB ACS</acronym>
  <official_title>Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients</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>
      Thi is an observational, non interventional, cohort analysis by using administrative&#xD;
      databases (drugs treatment, laboratory and diagnostic tests, specialist visits and&#xD;
      hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute&#xD;
      Coronary Syndrome (ACS) event.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HEALTH-DB ACS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The diagnostic path for each patient included in the analysis will be described by using all prescription for laboratory test (eg. total cholesterol, LDL cholesterol) and/or diagnostics tests (eg. electrocardiogram) during the observation period.</measure>
    <time_frame>up to 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The drugs treatment path will be described by using all prescriptions of antihypertensive drugs, lipid-lowering drugs and antiplatelet drugs during the observation period.</measure>
    <time_frame>up to 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to treatment will be calculated in the manner suggested by the literature and used in previous publications. Different methods of assessment will, however, used in order to study the variability of results. The analysis will be conducted over</measure>
    <time_frame>up to 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions.</measure>
    <time_frame>up to 2 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients discharged alive from an hospitalization for Acute Myocardial Infarction (AMI)&#xD;
        between January, 1st 2008 and December, 31st 2010 (inclusion period) will be included into&#xD;
        analysis. The discharge date will be defined as &quot;inclusion date&quot;.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects discharged alive from hospitalization for ACS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients that don't have a continuative presence as beneficiaries of the region&#xD;
             between January 1st, 2007 and December 31st 2011 will be excluded from analysis.&#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>Flore La Tour</last_name>
    <role>Study Chair</role>
    <affiliation>AstraZeneca CLINICAL RESEARCH DIRECTOR</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raffaele Sabia</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca Italy - VP MEDICAL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rosalia Traiana, Doctor of Pharmacology</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pharmaceutical Health - SICILIAN REGION</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ACS</keyword>
  <keyword>AMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Infarction</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/NCT01678339
org study id: NIS-CIT-XXX-2012/1
nct id: NCT01678339
lead sponsor: 
has dmc: No
Thi is an observational, non interventional, cohort analysis by using administrative
      databases (drugs treatment, laboratory and diagnostic tests, specialist visits and
      hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute
      Coronary Syndrome (ACS) event.
HEALTH-DB ACS
observational model: Cohort
time perspective: Retrospective
measure: The diagnostic path for each patient included in the analysis will be described by using all prescription for laboratory test (eg. total cholesterol, LDL cholesterol) and/or diagnostics tests (eg. electrocardiogram) during the observation period.
time frame: up to 2 years
measure: The drugs treatment path will be described by using all prescriptions of antihypertensive drugs, lipid-lowering drugs and antiplatelet drugs during the observation period.
time frame: up to 2 years
measure: Adherence to treatment will be calculated in the manner suggested by the literature and used in previous publications. Different methods of assessment will, however, used in order to study the variability of results. The analysis will be conducted over
time frame: up to 2 years
measure: The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions.
time frame: up to 2 years
arm group label: 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Flore La Tour
role: Study Chair
affiliation: AstraZeneca CLINICAL RESEARCH DIRECTOR
last name: Raffaele Sabia
role: Study Director
affiliation: AstraZeneca Italy - VP MEDICAL
last name: Rosalia Traiana, Doctor of Pharmacology
role: Principal Investigator
affiliation: Department of Pharmaceutical Health - SICILIAN REGION
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Infarction