<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/NCT03789916</url>
  </required_header>
  <id_info>
    <org_study_id>72.18</org_study_id>
    <nct_id>NCT03789916</nct_id>
  </id_info>
  <brief_title>SAPT Versus DAPT in Incomplete Revascularization After CABG</brief_title>
  <acronym>SDAT-IRC</acronym>
  <official_title>Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Campus Bio-Medico University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single&#xD;
      antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary&#xD;
      artery bypass graft surgery (CABG).&#xD;
&#xD;
      Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100&#xD;
      mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be&#xD;
      continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the&#xD;
      evaluation of cardiac-related mortality at 5 years from hospital discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</primary_completion_date>
  <phase>Phase 3</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-related mortality</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>5 years</time_frame>
    <description>Overall mortality and non-cardiac-related mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac and cerebrovascular events (MACCEs)</measure>
    <time_frame>5 years</time_frame>
    <description>cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse hemorrhagic events (MAHEs)</measure>
    <time_frame>5 years</time_frame>
    <description>stroke, gastrointestinal bleeding, life-threatening bleeding</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>DAPT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Dual antiplatelet therapy&quot;: acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAPT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>&quot;Single antiplatelet therapy&quot;: acetylsalicylic acid 100 mg/die</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor</intervention_name>
    <description>90 mg bis in die</description>
    <arm_group_label>DAPT</arm_group_label>
    <other_name>Brilique</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>acetylsalicylic acid</intervention_name>
    <description>100 mg die</description>
    <arm_group_label>DAPT</arm_group_label>
    <arm_group_label>SAPT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac&#xD;
             procedures (valve replacement,...)&#xD;
&#xD;
          -  incomplete myocardial revascularization, defined by anatomic or functional criteria&#xD;
&#xD;
          -  obtained informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute coronary syndrome &lt; 12 months from surgery&#xD;
&#xD;
          -  dual antiplatelet therapy at hospital admission&#xD;
&#xD;
          -  planned procedure to complete myocardial revascularization (e.g. hybrid approach)&#xD;
&#xD;
          -  intolerance / unable to take acetylsalicylic acid or ticagrelor&#xD;
&#xD;
          -  preoperative atrial fibrillation&#xD;
&#xD;
          -  impaired compliance&#xD;
&#xD;
          -  planned pregnancy&#xD;
&#xD;
          -  history of gastrointestinal bleeding&#xD;
&#xD;
          -  chronic kidney disease (eGFR &lt; 30 mL/min/1.73 m2)&#xD;
&#xD;
          -  chronic liver disease&#xD;
&#xD;
          -  severe heart failure at hospital admission&#xD;
&#xD;
          -  active malignancy&#xD;
&#xD;
          -  alcohol abuse&#xD;
&#xD;
          -  any clinical condition not compatible with the treatment&#xD;
&#xD;
        Exit Criteria:&#xD;
&#xD;
          -  postoperative atrial fibrillation requiring anticoagulation&#xD;
&#xD;
          -  postoperative hemorrhagic events (stroke, GI bleeding)&#xD;
&#xD;
          -  occurrence of contraindications to acetylsalicylic acid or ticagrelor&#xD;
&#xD;
          -  surgical treatment requiring DAPT withdrawn&#xD;
&#xD;
          -  patient decision&#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>Massimo Chello, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Università Campus Bio-Medico di Roma, Rome, Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antonio Nenna, MD</last_name>
    <phone>+393337014743</phone>
    <email>a.nenna@unicampus.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Massimo Chello, MD</last_name>
    <email>m.chello@unicampus.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Università Campus Bio-Medico di Roma</name>
      <address>
        <city>Rome</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Nenna, MD</last_name>
      <phone>+393337014743</phone>
      <email>a.nenna@unicampus.it</email>
    </contact>
    <contact_backup>
      <last_name>Massimo Chello, MD</last_name>
      <email>m.chello@unicampus.it</email>
    </contact_backup>
    <investigator>
      <last_name>Antonio Nenna, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Massimo Chello, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Spadaccio C, Nappi F, Nenna A, Beattie G, Chello M, Sutherland FW. Is it time to change how we think about incomplete coronary revascularization? Int J Cardiol. 2016 Dec 1;224:295-298. doi: 10.1016/j.ijcard.2016.09.055. Epub 2016 Sep 18.</citation>
    <PMID>27665400</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campus Bio-Medico University</investigator_affiliation>
    <investigator_full_name>Antonio Nenna, MD</investigator_full_name>
    <investigator_title>Cardiovascular Surgery</investigator_title>
  </responsible_party>
  <keyword>coronary artery bypass grafting</keyword>
  <keyword>incomplete revascularization</keyword>
  <keyword>coronary artery disease</keyword>
  <keyword>dual antiplatelet therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Ticagrelor</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT03789916
org study id: 72.18
nct id: NCT03789916
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single
      antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary
      artery bypass graft surgery (CABG).

      Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100
      mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be
      continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the
      evaluation of cardiac-related mortality at 5 years from hospital discharge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cardiac-related mortality
time frame: 5 years
measure: Mortality
time frame: 5 years
description: Overall mortality and non-cardiac-related mortality
measure: Major adverse cardiac and cerebrovascular events (MACCEs)
time frame: 5 years
description: cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke
measure: Major adverse hemorrhagic events (MAHEs)
time frame: 5 years
description: stroke, gastrointestinal bleeding, life-threatening bleeding
arm group label: DAPT
arm group type: Experimental
description: "Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die
arm group label: SAPT
arm group type: Active Comparator
description: "Single antiplatelet therapy": acetylsalicylic acid 100 mg/die
intervention type: Drug
intervention name: Ticagrelor
description: 90 mg bis in die
arm group label: DAPT
other name: Brilique
intervention type: Drug
intervention name: acetylsalicylic acid
description: 100 mg die
arm group label: DAPT
arm group label: SAPT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Massimo Chello, MD
role: Study Chair
affiliation: Università Campus Bio-Medico di Roma, Rome, Italy
last name: Antonio Nenna, MD
phone: +393337014743
email: a.nenna@unicampus.it
last name: Massimo Chello, MD
email: m.chello@unicampus.it
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Italy
citation: Spadaccio C, Nappi F, Nenna A, Beattie G, Chello M, Sutherland FW. Is it time to change how we think about incomplete coronary revascularization? Int J Cardiol. 2016 Dec 1;224:295-298. doi: 10.1016/j.ijcard.2016.09.055. Epub 2016 Sep 18.
PMID: 27665400
responsible party type: Principal Investigator
investigator affiliation: Campus Bio-Medico University
investigator full name: Antonio Nenna, MD
investigator title: Cardiovascular Surgery
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Aspirin
mesh term: Ticagrelor
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)