<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/NCT04462315</url>
  </required_header>
  <id_info>
    <org_study_id>HCB/2018/0906</org_study_id>
    <nct_id>NCT04462315</nct_id>
  </id_info>
  <brief_title>10-Years Follow-up of the EXAMINATION Trial</brief_title>
  <acronym>EXAMINAT10N</acronym>
  <official_title>Ten-year Follow-up of the Clinical Evaluation of Everolimus-Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION-EXTEND Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>No</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>
      The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES)&#xD;
      versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction&#xD;
      (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at&#xD;
      5-year. However, very-long term follow-up is unknown. The study had an independent Clinical&#xD;
      event Committee (CEC). All events were adjudicated by an independent clinical committee,&#xD;
      according to the Academic Research Consortium 1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Patient-oriented Composite Endpoint (PoCE)</measure>
    <time_frame>10 years</time_frame>
    <description>Rate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device-oriented Composite Endpoint (DoCE)</measure>
    <time_frame>10 years</time_frame>
    <description>Rate of composite endpoint of cardiac death, Target vessel myocardial infarction, and Target lesion revascularization. Defined according to the Academic Research Consortium 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of all cause and cardiac mortality</measure>
    <time_frame>10 years</time_frame>
    <description>Defined according to the Academic Research Consortium 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of recurrent myocardial infarction</measure>
    <time_frame>10 years</time_frame>
    <description>Defined according to the Academic Research Consortium 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of target lesion revascularization</measure>
    <time_frame>10 years</time_frame>
    <description>Defined according to the Academic Research Consortium 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of stent thrombosis</measure>
    <time_frame>10 years</time_frame>
    <description>Defined according to the Academic Research Consortium 1.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1498</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>ST Elevation Myocardial Infarction</condition>
  <condition>Infarction</condition>
  <condition>Necrosis</condition>
  <condition>Heart Disease</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Vascular Diseases</condition>
  <arm_group>
    <arm_group_label>Everolimus Arm</arm_group_label>
    <description>Everolimus Eluting Coronary Stent System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-drug eluting stent Arm</arm_group_label>
    <description>Cobalt chromium balloon-expandable stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Everolimus Eluting Coronary Stent System</intervention_name>
    <description>Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation</description>
    <arm_group_label>Everolimus Arm</arm_group_label>
    <other_name>N/H</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)</intervention_name>
    <description>Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation</description>
    <arm_group_label>Non-drug eluting stent Arm</arm_group_label>
    <other_name>N/H</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The EXAMINATION trial population was an all-comers population with ST-elevation myocardial&#xD;
        infarction, representative of routine clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were enrolled in the EXAMINATION trial (NCT00828087).&#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>Salvatore Brugaletta, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Josep Gómez-Lara, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitari de Bellvitge</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luis Ortega-Paz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manel Sabaté, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliera Bolognini</name>
      <address>
        <city>Seriate</city>
        <state>Bergamo</state>
        <zip>24068</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria S. Anna di Ferrara</name>
      <address>
        <city>Ferrara</city>
        <zip>44100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC, Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario U. A Coruña</name>
      <address>
        <city>A Coruña</city>
        <state>Galicia</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Álvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <state>Galicia</state>
        <zip>36214</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Dureta</name>
      <address>
        <city>Palma De Mallorca</city>
        <state>Mallorca</state>
        <zip>07014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Alicante</name>
      <address>
        <city>Alicante</city>
        <state>Valencia</state>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Brugaletta S, Backx B, Serruys P. Rationale and design of the EXAMINATION trial: a randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction. EuroIntervention. 2011 Dec;7(8):977-84. doi: 10.4244/EIJV7I8A154.</citation>
    <PMID>22115622</PMID>
  </reference>
  <reference>
    <citation>Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gomez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012 Oct 27;380(9852):1482-90. doi: 10.1016/S0140-6736(12)61223-9. Epub 2012 Sep 3.</citation>
    <PMID>22951305</PMID>
  </reference>
  <reference>
    <citation>Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, Mainar V, Campo G, Tespili M, den Heijer P, Bethencourt A, Vazquez N, van Es GA, Backx B, Valgimigli M, Serruys PW. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial. Lancet. 2016 Jan 23;387(10016):357-366. doi: 10.1016/S0140-6736(15)00548-6. Epub 2015 Oct 29.</citation>
    <PMID>26520230</PMID>
  </reference>
  <reference>
    <citation>Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.</citation>
    <PMID>17470709</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>August 29, 2022</last_update_submitted>
  <last_update_submitted_qc>August 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute myocardial infarction</keyword>
  <keyword>Primary Percutaneous Coronary Intervention</keyword>
  <keyword>Drug-Eluting Stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cobalt</mesh_term>
    <mesh_term>Chromium</mesh_term>
    <mesh_term>Everolimus</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Will be made available upon request.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT04462315/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT04462315/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04462315
org study id: HCB/2018/0906
nct id: NCT04462315
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES)
      versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction
      (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at
      5-year. However, very-long term follow-up is unknown. The study had an independent Clinical
      event Committee (CEC). All events were adjudicated by an independent clinical committee,
      according to the Academic Research Consortium 1.
observational model: Cohort
time perspective: Prospective
measure: Patient-oriented Composite Endpoint (PoCE)
time frame: 10 years
description: Rate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.
measure: Device-oriented Composite Endpoint (DoCE)
time frame: 10 years
description: Rate of composite endpoint of cardiac death, Target vessel myocardial infarction, and Target lesion revascularization. Defined according to the Academic Research Consortium 1.
measure: Rate of all cause and cardiac mortality
time frame: 10 years
description: Defined according to the Academic Research Consortium 1.
measure: Rate of recurrent myocardial infarction
time frame: 10 years
description: Defined according to the Academic Research Consortium 1.
measure: Rate of target lesion revascularization
time frame: 10 years
description: Defined according to the Academic Research Consortium 1.
measure: Rate of stent thrombosis
time frame: 10 years
description: Defined according to the Academic Research Consortium 1.
arm group label: Everolimus Arm
description: Everolimus Eluting Coronary Stent System
arm group label: Non-drug eluting stent Arm
description: Cobalt chromium balloon-expandable stent
intervention type: Drug
intervention name: Everolimus Eluting Coronary Stent System
description: Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
arm group label: Everolimus Arm
other name: N/H
intervention type: Device
intervention name: Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)
description: Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation
arm group label: Non-drug eluting stent Arm
other name: N/H
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Salvatore Brugaletta, MD, PhD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
last name: Josep Gómez-Lara, MD, PhD
role: Principal Investigator
affiliation: Hospital Universitari de Bellvitge
last name: Luis Ortega-Paz, MD, PhD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
last name: Manel Sabaté, MD, PhD
role: Study Chair
affiliation: Hospital Clinic of Barcelona
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
country: Netherlands
country: Spain
citation: Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Brugaletta S, Backx B, Serruys P. Rationale and design of the EXAMINATION trial: a randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction. EuroIntervention. 2011 Dec;7(8):977-84. doi: 10.4244/EIJV7I8A154.
PMID: 22115622
citation: Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gomez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012 Oct 27;380(9852):1482-90. doi: 10.1016/S0140-6736(12)61223-9. Epub 2012 Sep 3.
PMID: 22951305
citation: Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, Mainar V, Campo G, Tespili M, den Heijer P, Bethencourt A, Vazquez N, van Es GA, Backx B, Valgimigli M, Serruys PW. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial. Lancet. 2016 Jan 23;387(10016):357-366. doi: 10.1016/S0140-6736(15)00548-6. Epub 2015 Oct 29.
PMID: 26520230
citation: Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
PMID: 17470709
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Myocardial Infarction
mesh term: Heart Diseases
mesh term: Vascular Diseases
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
mesh term: Necrosis
mesh term: Cobalt
mesh term: Chromium
mesh term: Everolimus
sharing ipd: No
ipd description: Will be made available upon request.
provided document: 
provided document: 