<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/NCT04481997</url>
  </required_header>
  <id_info>
    <org_study_id>CET.NIS2020.01</org_study_id>
    <secondary_id>ESR-19-20188</secondary_id>
    <nct_id>NCT04481997</nct_id>
  </id_info>
  <brief_title>Anti-thrombotic and Glucose Lowering Therapy in Diabetic Patients Undergoing PCI</brief_title>
  <acronym>ARTHEMIS</acronym>
  <official_title>Anti-thrombotic and Glucose loweRing THerapy in diabEtics With CAD Undergoing PCI: a Prospective Multicenter observatIonal Study on Their Use and Implications for Clinical Outcomes - The ARTHEMIS Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardiovascular Centre of the University of Lisbon (CCUL)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes mellitus (DM) is one of the main risk factors for ischemic events in patients with&#xD;
      coronary artery disease (CAD) and diabetes is a factor in several post-PCI (Percutaneous&#xD;
      Coronary Intervention) risk scores. However, until recently, there were almost no studies&#xD;
      performed specifically in the diabetic population of patients undergoing PCI. This study aims&#xD;
      to describe the anti-thrombotic regimens, clinical outcomes and current diabetes medical&#xD;
      treatment in an unselected consecutive population of patients with DM undergoing PCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes is one of the main risk factors for ischemic events in patients with coronary artery&#xD;
      disease and diabetes is a factor in several post-PCI risk scores (including the commonly used&#xD;
      DAPT score). However, until recently, there were almost no studies performed specifically in&#xD;
      the diabetic population of patients undergoing PCI. At large, results from randomized trials&#xD;
      assessing the duration of DAPT have produced conflicting results and there is uncertainty&#xD;
      about the best anti-thrombotic strategy in patients with diabetes. Further assessment of the&#xD;
      patterns of use and their clinical effects, including those related to prolonged DAPT is&#xD;
      needed, in diabetic patients, especially in less selected &quot;real world&quot; populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 11, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Enumeration of the anti-thrombotic agents prescribed to patients</measure>
    <time_frame>Baseline to 24 months follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Planned duration of dual anti-platelet treatment (DAPT) after the PCI.</measure>
    <time_frame>From index admission to 24 months follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to anti-thrombotic regimen</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
    <description>Classified qualitatively according to the assessment of the attending physician.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actual duration of DAPT (if different from the planned duration)</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for interrupting DAPT at a time different from the planned duration</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for prolonging DAPT over 1 year</measure>
    <time_frame>12 to 24 months follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Coronary Events (MACE)</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
    <description>Major Adverse Coronary Events (MACE) (death from any cause, new spontaneous acute myocardial infarction, stroke).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death rate from any cause</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of cardiovascular death</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of new spontaneous acute myocardial infarction</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of hospital admissions for acute coronary infarction</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of unplanned coronary revascularization</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of stroke/transient ischemic attack</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death rate from heart failure</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of hospital admission due to heart failure</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding events of type 3-5 of BARC (Bleeding Academic Research Consortium) scale</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
    <description>The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will only be collected the events corresponding to type 3-5 of BARC scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding events of type 1-5 of BARC (Bleeding Academic Research Consortium) scale</measure>
    <time_frame>6 to 24 months follow-up</time_frame>
    <description>The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will be collected the events corresponding to type 1-5 of BARC scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients treated with different glucose-lowering drugs.</measure>
    <time_frame>Before index admission to 24 months follow-up.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes control (HbA1c values)</measure>
    <time_frame>At baseline to 24 months follow-up</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>Diabetic patients with CAD submitted to PCI</arm_group_label>
    <description>Individuals with type 2 Diabetes mellitus (previously diagnosed or diagnosed at index admission) submitted to PCI</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exposure to Anti-thrombotic treatment agents and glucose lowering therapy</intervention_name>
    <description>Exposure to Anti-thrombotic treatment agents and glucose lowering therapy</description>
    <arm_group_label>Diabetic patients with CAD submitted to PCI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1000 Type 2 Diabetes mellitus consecutive patients submitted to PCI in 12 interventional&#xD;
        Cardiology Portuguese centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCI with stent implantation, performed in at least one major coronary artery in the&#xD;
             context of stable coronary artery disease or acute coronary syndrome&#xD;
&#xD;
          -  Type 2 Diabetes mellitus (previously diagnosed or diagnosed at the index admission)&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
          -  Patient not simultaneously participating in any interventional study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Type 1 Diabetes mellitus&#xD;
&#xD;
          -  Patients whose survival is expected to be lower than 1 year at hospital discharge&#xD;
&#xD;
          -  Patients not whiling to participate&#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>Sérgio B Baptista, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiovascular Centre of the University of Lisbon (CCUL)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luís Raposo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Santa Cruz, CHLO, EPE, Lisbon, Portugal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Prof. Doutor Fernando Fonseca</name>
      <address>
        <city>Amadora</city>
        <state>Lisbon</state>
        <zip>2720-276</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz</name>
      <address>
        <city>Carnaxide</city>
        <state>Lisbon</state>
        <zip>2790-134</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Lisboa Central - Hospital de Santa Marta</name>
      <address>
        <city>Lisboa</city>
        <state>Lisbon</state>
        <zip>1159-064</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <state>Lisbon</state>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE</name>
      <address>
        <city>Vila Nova De Gaia</city>
        <state>Porto</state>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Garcia de Orta</name>
      <address>
        <city>Almada</city>
        <state>Setúbal</state>
        <zip>2805-267</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Braga, EPE</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar e Universitário de Coimbra - Hospital Geral &amp; Hospital Universitário de Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário do Algarve - Hospital de Faro</name>
      <address>
        <city>Faro</city>
        <zip>8000-386</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Setúbal</name>
      <address>
        <city>Setúbal</city>
        <zip>2910-549</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Espírito Santo de Évora, EPE</name>
      <address>
        <city>Évora</city>
        <zip>7000-811</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PCI-Percutaneous Coronary Intervention</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Dual Antiplatelet Therapy</keyword>
  <keyword>Anti-diabetic drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04481997
org study id: CET.NIS2020.01
secondary id: ESR-19-20188
nct id: NCT04481997
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Diabetes mellitus (DM) is one of the main risk factors for ischemic events in patients with
      coronary artery disease (CAD) and diabetes is a factor in several post-PCI (Percutaneous
      Coronary Intervention) risk scores. However, until recently, there were almost no studies
      performed specifically in the diabetic population of patients undergoing PCI. This study aims
      to describe the anti-thrombotic regimens, clinical outcomes and current diabetes medical
      treatment in an unselected consecutive population of patients with DM undergoing PCI.
Diabetes is one of the main risk factors for ischemic events in patients with coronary artery
      disease and diabetes is a factor in several post-PCI risk scores (including the commonly used
      DAPT score). However, until recently, there were almost no studies performed specifically in
      the diabetic population of patients undergoing PCI. At large, results from randomized trials
      assessing the duration of DAPT have produced conflicting results and there is uncertainty
      about the best anti-thrombotic strategy in patients with diabetes. Further assessment of the
      patterns of use and their clinical effects, including those related to prolonged DAPT is
      needed, in diabetic patients, especially in less selected "real world" populations.
observational model: Cohort
time perspective: Prospective
measure: Enumeration of the anti-thrombotic agents prescribed to patients
time frame: Baseline to 24 months follow-up
measure: Planned duration of dual anti-platelet treatment (DAPT) after the PCI.
time frame: From index admission to 24 months follow-up
measure: Adherence to anti-thrombotic regimen
time frame: 6 to 24 months follow-up
description: Classified qualitatively according to the assessment of the attending physician.
measure: Actual duration of DAPT (if different from the planned duration)
time frame: 6 to 24 months follow-up
measure: Reasons for interrupting DAPT at a time different from the planned duration
time frame: 6 to 24 months follow-up
measure: Reasons for prolonging DAPT over 1 year
time frame: 12 to 24 months follow-up
measure: Major Adverse Coronary Events (MACE)
time frame: 6 to 24 months follow-up
description: Major Adverse Coronary Events (MACE) (death from any cause, new spontaneous acute myocardial infarction, stroke).
measure: Death rate from any cause
time frame: 6 to 24 months follow-up
measure: Rate of cardiovascular death
time frame: 6 to 24 months follow-up
measure: Rate of new spontaneous acute myocardial infarction
time frame: 6 to 24 months follow-up
measure: Rate of hospital admissions for acute coronary infarction
time frame: 6 to 24 months follow-up
measure: Rate of unplanned coronary revascularization
time frame: 6 to 24 months follow-up
measure: Rate of stroke/transient ischemic attack
time frame: 6 to 24 months follow-up
measure: Death rate from heart failure
time frame: 6 to 24 months follow-up
measure: Rate of hospital admission due to heart failure
time frame: 6 to 24 months follow-up
measure: Rate of bleeding events of type 3-5 of BARC (Bleeding Academic Research Consortium) scale
time frame: 6 to 24 months follow-up
description: The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will only be collected the events corresponding to type 3-5 of BARC scale.
measure: Rate of bleeding events of type 1-5 of BARC (Bleeding Academic Research Consortium) scale
time frame: 6 to 24 months follow-up
description: The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will be collected the events corresponding to type 1-5 of BARC scale.
measure: Percentage of patients treated with different glucose-lowering drugs.
time frame: Before index admission to 24 months follow-up.
measure: Diabetes control (HbA1c values)
time frame: At baseline to 24 months follow-up
arm group label: Diabetic patients with CAD submitted to PCI
description: Individuals with type 2 Diabetes mellitus (previously diagnosed or diagnosed at index admission) submitted to PCI
intervention type: Other
intervention name: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy
description: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy
arm group label: Diabetic patients with CAD submitted to PCI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sérgio B Baptista, PhD
role: Principal Investigator
affiliation: Cardiovascular Centre of the University of Lisbon (CCUL)
last name: Luís Raposo, MD
role: Principal Investigator
affiliation: Hospital de Santa Cruz, CHLO, EPE, Lisbon, Portugal
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided