xml: <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/NCT05997693</url>
    </required_header>
    <id_info>
      <org_study_id>23-06026202</org_study_id>
      <secondary_id>2023-506613-22</secondary_id>
      <secondary_id>488058</secondary_id>
      <nct_id>NCT05997693</nct_id>
    </id_info>
    <brief_title>One-Month DAPT in CABG Patients</brief_title>
    <acronym>ODIN</acronym>
    <official_title>One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Weill Medical College of Cornell University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Weill Medical College of Cornell University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to compare the effect of ticagrelor versus placebo in patients&#xD;
        with chronic coronary disease undergoing coronary artery bypass grafting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A multinational, randomized, double-blind, placebo-controlled trial to evaluate the effect of&#xD;
        one-month ticagrelor twice daily in addition to low-dose aspirin on the incidence of death,&#xD;
        myocardial infarction, stroke, repeat revascularization and graft failure in patients with&#xD;
        chronic coronary disease undergoing coronary artery bypass grafting.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">January 2031</completion_date>
    <primary_completion_date type="Anticipated">January 2027</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>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.</measure>
      <time_frame>1 year</time_frame>
      <description>This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:&#xD;
  Time to all-cause mortality&#xD;
  Time to stroke&#xD;
  Time to myocardial infarction&#xD;
  Time to coronary revascularization&#xD;
  Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.</measure>
      <time_frame>1 year</time_frame>
      <description>This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:&#xD;
  Time to all-cause mortality&#xD;
  Time to stroke&#xD;
  Time to myocardial infarction&#xD;
  Time to BARC 3 bleeding&#xD;
  Time to coronary revascularization&#xD;
  Presence of graft failure at 12-month imaging follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and 5-year time-averaged disease-specific (Seattle Angina Questionnaire [SAQ]-7) quality of life (QoL) score</measure>
      <time_frame>5 years</time_frame>
      <description>This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:&#xD;
  Time to all-cause mortality&#xD;
  Time to stroke&#xD;
  Time to myocardial infarction&#xD;
  Time to coronary revascularization&#xD;
  5-year time-averaged disease-specific QOL (SAQ-7) score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score.</measure>
      <time_frame>5 years</time_frame>
      <description>This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:&#xD;
  Time to all-cause mortality&#xD;
  Time to stroke&#xD;
  Time to myocardial infarction&#xD;
  Time to BARC 3 bleeding&#xD;
  Time to coronary revascularization&#xD;
  5-year time-averaged disease-specific QOL (SAQ-7) score</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">700</enrollment>
    <condition>Chronic Coronary Disease</condition>
    <arm_group>
      <arm_group_label>Ticagrelor 90 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Ticagrelor placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ticagrelor 90 MG</intervention_name>
      <description>Ticagrelor 90 mg bd taken orally</description>
      <arm_group_label>Ticagrelor 90 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ticagrelor placebo</intervention_name>
      <description>Ticagrelor placebo bd taken orally</description>
      <arm_group_label>Ticagrelor placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  Elective first-time CABG with use of ≥1 saphenous vein graft;&#xD;
  &#xD;
            -  Ability to sign informed consent and comply with all study procedures, including&#xD;
               follow-up for at least 5 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any indication for dual antiplatelet therapy, including&#xD;
  &#xD;
                 -  Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI)&#xD;
  &#xD;
                 -  Recent PCI requiring continuation of dual antiplatelet therapy after CABG&#xD;
  &#xD;
            -  Current or anticipated use of oral anticoagulation;&#xD;
  &#xD;
            -  Paroxysmal, persistent or permanent atrial fibrillation;&#xD;
  &#xD;
            -  Any concomitant cardiac or non-cardiac procedure;&#xD;
  &#xD;
            -  Planned cardiac or non-cardiac surgery within one year;&#xD;
  &#xD;
            -  Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure,&#xD;
               respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy&#xD;
               &lt;5 years;&#xD;
  &#xD;
            -  Inability to use the saphenous vein;&#xD;
  &#xD;
            -  Contraindications to the use of aspirin;&#xD;
  &#xD;
            -  Contraindications to the use of ticagrelor, including&#xD;
  &#xD;
                 -  Known hypersensitivity to ticagrelor&#xD;
  &#xD;
                 -  Active pathological bleeding (including, but not limited to gastrointestinal or&#xD;
                    intracranial bleeding)&#xD;
  &#xD;
                 -  History of intracranial hemorrhage&#xD;
  &#xD;
                 -  Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole,&#xD;
                    clarithromycin, nefazodone, ritonavir, atazanavir)&#xD;
  &#xD;
            -  Inability to undergo coronary computed tomographic angiography (CCTA);&#xD;
  &#xD;
            -  Participating in another investigational device or drug study;&#xD;
  &#xD;
            -  Women of childbearing potential&#xD;
  &#xD;
            -  Any major perioperative complication including, but not limited to, stroke, TIA, MI,&#xD;
               CABG-related bleeding (BARC type 4), sepsis.&#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>Marc Ruel, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mario Gaudino, MD, PhD, MSCE</last_name>
      <role>Principal Investigator</role>
      <affiliation>Weill Medical College of Cornell University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trisha Ali-Shaw</last_name>
      <phone>646-962-8281</phone>
      <email>tra2002@med.cornell.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mustafa Gadelrab</last_name>
      <email>mug4002@med.cornell.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Weill Cornell Medicine</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Mario Gaudino, MD, PhD, MSCE</last_name>
      </contact>
      <investigator>
        <last_name>Mario Gaudino, MD, PhD, MSCE</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical University Graz</name>
        <address>
          <city>Graz</city>
          <country>Austria</country>
        </address>
      </facility>
      <contact>
        <last_name>Christina Just</last_name>
      </contact>
      <investigator>
        <last_name>Daniel Zimpfer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical University Innsbruck</name>
        <address>
          <city>Innsbruck</city>
          <country>Austria</country>
        </address>
      </facility>
      <contact>
        <last_name>Elfriede Ruttmann-Ulmer</last_name>
      </contact>
      <investigator>
        <last_name>Elfriede Ruttmann-Ulmer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Johannes Kepler University Linz</name>
        <address>
          <city>Linz</city>
          <country>Austria</country>
        </address>
      </facility>
      <contact>
        <last_name>Peter Benedikt</last_name>
      </contact>
      <investigator>
        <last_name>Andreas Zierer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical University of Vienna</name>
        <address>
          <city>Vienna</city>
          <zip>1090</zip>
          <country>Austria</country>
        </address>
      </facility>
      <contact>
        <last_name>Sabine Freilinger</last_name>
      </contact>
      <investigator>
        <last_name>Sigrid Sandner, MD, MSCE</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Ottawa Heart Institute</name>
        <address>
          <city>Ottawa</city>
          <state>Ontario</state>
          <zip>K1Y 4W7</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Marc Ruel, MD, MPH</last_name>
        <email>mruel@ottawaheart.ca</email>
      </contact>
      <investigator>
        <last_name>Marc Ruel, MD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen</name>
        <address>
          <city>Essen</city>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Matthias Thielmann</last_name>
      </contact>
      <investigator>
        <last_name>Matthias Thielmann</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen</name>
        <address>
          <city>Freiburg</city>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Alicja Zientara</last_name>
      </contact>
      <investigator>
        <last_name>Martin Czerny</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Universitätsklinikum Giessen</name>
        <address>
          <city>Giessen</city>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Melanie Spänig</last_name>
      </contact>
      <investigator>
        <last_name>Andreas Böning</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>LMU Klinikum Campus Großhadern</name>
        <address>
          <city>München</city>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Robert-Bosch-Krankenhaus Stuttgart</name>
        <address>
          <city>Stuttgart</city>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Marc Albert</last_name>
      </contact>
      <investigator>
        <last_name>Marc Albert</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Sahlgrenska University Hospital Sweden</name>
        <address>
          <city>Gothenburg</city>
          <country>Sweden</country>
        </address>
      </facility>
      <contact>
        <last_name>Bjorn Redfors, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Bjorn Redfors, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Austria</country>
      <country>Canada</country>
      <country>Germany</country>
      <country>Sweden</country>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Sandner S, Redfors B, Angiolillo DJ, Audisio K, Fremes SE, Janssen PWA, Kulik A, Mehran R, Peper J, Ruel M, Saw J, Soletti GJ, Starovoytov A, Ten Berg JM, Willemsen LM, Zhao Q, Zhu Y, Gaudino M. Association of Dual Antiplatelet Therapy With Ticagrelor With Vein Graft Failure After Coronary Artery Bypass Graft Surgery: A Systematic Review and Meta-analysis. JAMA. 2022 Aug 9;328(6):554-562. doi: 10.1001/jama.2022.11966.</citation>
      <PMID>35943473</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ticagrelor</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997693
  org study id: 23-06026202
  secondary id: 2023-506613-22
  secondary id: 488058
  nct id: NCT05997693
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to compare the effect of ticagrelor versus placebo in patients
        with chronic coronary disease undergoing coronary artery bypass grafting.
  A multinational, randomized, double-blind, placebo-controlled trial to evaluate the effect of
        one-month ticagrelor twice daily in addition to low-dose aspirin on the incidence of death,
        myocardial infarction, stroke, repeat revascularization and graft failure in patients with
        chronic coronary disease undergoing coronary artery bypass grafting.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.
  time frame: 1 year
  description: This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
  Time to all-cause mortality
  Time to stroke
  Time to myocardial infarction
  Time to coronary revascularization
  Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month
  measure: Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.
  time frame: 1 year
  description: This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
  Time to all-cause mortality
  Time to stroke
  Time to myocardial infarction
  Time to BARC 3 bleeding
  Time to coronary revascularization
  Presence of graft failure at 12-month imaging follow-up
  measure: Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and 5-year time-averaged disease-specific (Seattle Angina Questionnaire [SAQ]-7) quality of life (QoL) score
  time frame: 5 years
  description: This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
  Time to all-cause mortality
  Time to stroke
  Time to myocardial infarction
  Time to coronary revascularization
  5-year time-averaged disease-specific QOL (SAQ-7) score
  measure: Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score.
  time frame: 5 years
  description: This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
  Time to all-cause mortality
  Time to stroke
  Time to myocardial infarction
  Time to BARC 3 bleeding
  Time to coronary revascularization
  5-year time-averaged disease-specific QOL (SAQ-7) score
  arm group label: Ticagrelor 90 mg
  arm group type: Experimental
  arm group label: Ticagrelor placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Ticagrelor 90 MG
  description: Ticagrelor 90 mg bd taken orally
  arm group label: Ticagrelor 90 mg
  intervention type: Drug
  intervention name: Ticagrelor placebo
  description: Ticagrelor placebo bd taken orally
  arm group label: Ticagrelor placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marc Ruel, MD, MPH
  role: Principal Investigator
  affiliation: Ottawa Heart Institute Research Corporation
  last name: Mario Gaudino, MD, PhD, MSCE
  role: Principal Investigator
  affiliation: Weill Medical College of Cornell University
  last name: Trisha Ali-Shaw
  phone: 646-962-8281
  email: tra2002@med.cornell.edu
  last name: Mustafa Gadelrab
  email: mug4002@med.cornell.edu
  facility: 
  contact: 
  investigator: 
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  country: Austria
  country: Canada
  country: Germany
  country: Sweden
  country: United States
  citation: Sandner S, Redfors B, Angiolillo DJ, Audisio K, Fremes SE, Janssen PWA, Kulik A, Mehran R, Peper J, Ruel M, Saw J, Soletti GJ, Starovoytov A, Ten Berg JM, Willemsen LM, Zhao Q, Zhu Y, Gaudino M. Association of Dual Antiplatelet Therapy With Ticagrelor With Vein Graft Failure After Coronary Artery Bypass Graft Surgery: A Systematic Review and Meta-analysis. JAMA. 2022 Aug 9;328(6):554-562. doi: 10.1001/jama.2022.11966.
  PMID: 35943473
  responsible party type: Sponsor
  mesh term: Coronary Disease
  mesh term: Ticagrelor
  sharing ipd: No