<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/NCT01684982</url>
  </required_header>
  <id_info>
    <org_study_id>DiLOR_2012</org_study_id>
    <nct_id>NCT01684982</nct_id>
  </id_info>
  <brief_title>Everolimus Stent in Myocardial Infarction</brief_title>
  <acronym>RaCES-MI</acronym>
  <official_title>Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction (STEMI) (RaCES-MI Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Giuseppe Moscati Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Giuseppe Moscati Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in&#xD;
      patient with acute myocardial infarction treated with primary percutaneous coronary&#xD;
      intervention (PCI)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The efficacy and safety of drug-eluting stents (DES) in the treatment of coronary artery&#xD;
      disease is well established. It is well known that Drug Eluting Stent (DES) have dramatically&#xD;
      decreased Restenosis rates for both on-label and off-label indications. However, the concern&#xD;
      for increased (late) stent thrombosis is still present DES implantation in patient with acute&#xD;
      myocardial infarction is still controversial because acute coronary lesion presents the&#xD;
      highest possible thrombotic burden Newer DES with new antiproliferative drugs and more&#xD;
      biocompatible polymers have shown a significant reduction of (late) stent thrombosis in&#xD;
      patients in stable condition.&#xD;
&#xD;
      Aim of the study was to asses the long term efficacy and safety on second generation&#xD;
      everolimus eluting stent compared with first generation sirolimus eluting stent&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2007</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cardiac death, reinfarction and Target Vessel Revascularization (TVR)</measure>
    <time_frame>36 MONTHS</time_frame>
    <description>Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>everolimus eluting stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>second generation drug eluting stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sirolimus eluting stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>first generation drug eluting stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>everolimus eluting stent</intervention_name>
    <description>experimental arm of a comparison between drug eluting stents</description>
    <arm_group_label>everolimus eluting stent</arm_group_label>
    <other_name>XIENCE V Abbott Vascular</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sirolimus eluting stent</intervention_name>
    <description>control arm of a comparison between drug eluting stents</description>
    <arm_group_label>sirolimus eluting stent</arm_group_label>
    <other_name>CYPHER Johnson &amp; Johnson</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All ST segment elevation myocardial infarction (STEMI) patients eligible for primary&#xD;
             PCI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication to dual antiplatelet therapy for 12 months&#xD;
&#xD;
          2. Known allergy to sirolimus or everolimus&#xD;
&#xD;
          3. Major surgical procedure planned within 1 month.&#xD;
&#xD;
          4. History, symptoms, or findings suggestive of aortic dissection.&#xD;
&#xD;
          5. Participation in other trials&#xD;
&#xD;
          6. Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>EMILIO DI LORENZO, MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AO MOSCATI AVELLINO ITALY</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ROSARIO SAURO, MD</last_name>
    <role>Study Director</role>
    <affiliation>AO MOSCATI AVELLINO ITALY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Cardiology AO Moscati</name>
      <address>
        <city>Avellino</city>
        <zip>83100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>De Luca G, Dirksen MT, Spaulding C, Kelbaek H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Diaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Cortese G, Suryapranata H, Stone GW; Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med. 2012 Apr 23;172(8):611-21; discussion 621-2. doi: 10.1001/archinternmed.2012.758.</citation>
    <PMID>22529227</PMID>
  </reference>
  <reference>
    <citation>Di Lorenzo E, Carbone G, Sauro L, Casafina A, Capasso M, Sauro R. Bare-metal stents versus drug-eluting stents for primary angioplasty: long-term outcome. Curr Cardiol Rep. 2011 Oct;13(5):459-64. doi: 10.1007/s11886-011-0207-0.</citation>
    <PMID>21792636</PMID>
  </reference>
  <reference>
    <citation>Dibra A, Tiroch K, Schulz S, Kelbaek H, Spaulding C, Laarman GJ, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Campo G, Thuesen L, Vink MA, Schalij MJ, Violini R, Schomig A, Kastrati A. Drug-eluting stents in acute myocardial infarction: updated meta-analysis of randomized trials. Clin Res Cardiol. 2010 Jun;99(6):345-57. doi: 10.1007/s00392-010-0133-y. Epub 2010 Mar 11.</citation>
    <PMID>20221617</PMID>
  </reference>
  <reference>
    <citation>Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.</citation>
    <PMID>19781402</PMID>
  </reference>
  <reference>
    <citation>Hofma SH, Brouwer J, Velders MA, van't Hof AW, Smits PC, Quere M, de Vries CJ, van Boven AJ. Second-generation everolimus-eluting stents versus first-generation sirolimus-eluting stents in acute myocardial infarction. 1-year results of the randomized XAMI (XienceV Stent vs. Cypher Stent in Primary PCI for Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2012 Jul 31;60(5):381-7. doi: 10.1016/j.jacc.2012.01.073.</citation>
    <PMID>22835668</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>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>April 1, 2013</last_update_submitted>
  <last_update_submitted_qc>April 1, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Giuseppe Moscati Hospital</investigator_affiliation>
    <investigator_full_name>Emilio Di Lorenzo MD PhD</investigator_full_name>
    <investigator_title>Chief Interventional Cardiology</investigator_title>
  </responsible_party>
  <keyword>Primary PCI</keyword>
  <keyword>Drug Eluting Stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
    <mesh_term>Everolimus</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/NCT01684982
org study id: DiLOR_2012
nct id: NCT01684982
lead sponsor: 
has dmc: No
Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in
      patient with acute myocardial infarction treated with primary percutaneous coronary
      intervention (PCI)
The efficacy and safety of drug-eluting stents (DES) in the treatment of coronary artery
      disease is well established. It is well known that Drug Eluting Stent (DES) have dramatically
      decreased Restenosis rates for both on-label and off-label indications. However, the concern
      for increased (late) stent thrombosis is still present DES implantation in patient with acute
      myocardial infarction is still controversial because acute coronary lesion presents the
      highest possible thrombotic burden Newer DES with new antiproliferative drugs and more
      biocompatible polymers have shown a significant reduction of (late) stent thrombosis in
      patients in stable condition.

      Aim of the study was to asses the long term efficacy and safety on second generation
      everolimus eluting stent compared with first generation sirolimus eluting stent
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: cardiac death, reinfarction and Target Vessel Revascularization (TVR)
time frame: 36 MONTHS
description: Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery
measure: cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis
time frame: 36 months
arm group label: everolimus eluting stent
arm group type: Experimental
description: second generation drug eluting stent
arm group label: sirolimus eluting stent
arm group type: Active Comparator
description: first generation drug eluting stent
intervention type: Device
intervention name: everolimus eluting stent
description: experimental arm of a comparison between drug eluting stents
arm group label: everolimus eluting stent
other name: XIENCE V Abbott Vascular
intervention type: Device
intervention name: sirolimus eluting stent
description: control arm of a comparison between drug eluting stents
arm group label: sirolimus eluting stent
other name: CYPHER Johnson & Johnson
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: EMILIO DI LORENZO, MD PHD
role: Principal Investigator
affiliation: AO MOSCATI AVELLINO ITALY
last name: ROSARIO SAURO, MD
role: Study Director
affiliation: AO MOSCATI AVELLINO ITALY
facility: 
country: Italy
citation: De Luca G, Dirksen MT, Spaulding C, Kelbaek H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Diaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Cortese G, Suryapranata H, Stone GW; Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med. 2012 Apr 23;172(8):611-21; discussion 621-2. doi: 10.1001/archinternmed.2012.758.
PMID: 22529227
citation: Di Lorenzo E, Carbone G, Sauro L, Casafina A, Capasso M, Sauro R. Bare-metal stents versus drug-eluting stents for primary angioplasty: long-term outcome. Curr Cardiol Rep. 2011 Oct;13(5):459-64. doi: 10.1007/s11886-011-0207-0.
PMID: 21792636
citation: Dibra A, Tiroch K, Schulz S, Kelbaek H, Spaulding C, Laarman GJ, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Campo G, Thuesen L, Vink MA, Schalij MJ, Violini R, Schomig A, Kastrati A. Drug-eluting stents in acute myocardial infarction: updated meta-analysis of randomized trials. Clin Res Cardiol. 2010 Jun;99(6):345-57. doi: 10.1007/s00392-010-0133-y. Epub 2010 Mar 11.
PMID: 20221617
citation: Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.
PMID: 19781402
citation: Hofma SH, Brouwer J, Velders MA, van't Hof AW, Smits PC, Quere M, de Vries CJ, van Boven AJ. Second-generation everolimus-eluting stents versus first-generation sirolimus-eluting stents in acute myocardial infarction. 1-year results of the randomized XAMI (XienceV Stent vs. Cypher Stent in Primary PCI for Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2012 Jul 31;60(5):381-7. doi: 10.1016/j.jacc.2012.01.073.
PMID: 22835668
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
responsible party type: Principal Investigator
investigator affiliation: San Giuseppe Moscati Hospital
investigator full name: Emilio Di Lorenzo MD PhD
investigator title: Chief Interventional Cardiology
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Sirolimus
mesh term: Everolimus