<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/NCT03797651</url>
  </required_header>
  <id_info>
    <org_study_id>4-2018-0782</org_study_id>
    <nct_id>NCT03797651</nct_id>
  </id_info>
  <brief_title>Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial</brief_title>
  <official_title>Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events&#xD;
      without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor&#xD;
      monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will&#xD;
      also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary&#xD;
      syndrome. After confirmation of enrollment, patients will be randomized to continue standard&#xD;
      treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less&#xD;
      than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according&#xD;
      to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline&#xD;
      clinical and angiographic characteristics, laboratory findings will be assessed at the time&#xD;
      of randomization. All patients will provide informed consent on their own initiative.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 24, 2019</start_date>
  <completion_date type="Anticipated">April 4, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 4, 2025</primary_completion_date>
  <phase>N/A</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>Net clinical benefit</measure>
    <time_frame>1 year after procedure</time_frame>
    <description>A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Each components of net clinical benefit</measure>
    <time_frame>1 year after procedure</time_frame>
    <description>All-cause death, MI, stent thrombosis, stroke, major bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular mortality</measure>
    <time_frame>1 year after procedure</time_frame>
    <description>Cardiovascular mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major or minor bleeding</measure>
    <time_frame>1 year after procedure</time_frame>
    <description>Major or minor bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac event</measure>
    <time_frame>1 year after procedure</time_frame>
    <description>A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2850</enrollment>
  <condition>Coronary Artery Disease, Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Standard DAPT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Very-short DAPT within 1 month</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will stop aspirin after discharge (DAPT less than 1 months after PCI) (ticagrelor monotherapy). Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard DAPT</intervention_name>
    <description>Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.</description>
    <arm_group_label>Standard DAPT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Very-short DAPT less than 1 month after PCI</intervention_name>
    <description>Patient will stop aspirin (ticagrelor monotherapy) after discharge or within 1 month. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).</description>
    <arm_group_label>Very-short DAPT within 1 month</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients ≥19 years old&#xD;
&#xD;
          2. Patients who received new generation sirolimus-eluting (Orsiro® series) stent&#xD;
             implantation for treating ACS, including acute MI and unstable angina&#xD;
&#xD;
          3. Provision of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age&gt; 80 years&#xD;
&#xD;
          2. Increased risk of bleeding, anemia, thrombocytopenia&#xD;
&#xD;
          3. A need for oral anticoagulation therapy&#xD;
&#xD;
          4. Pregnant women or women with potential childbearing&#xD;
&#xD;
          5. Life expectancy &lt; 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myeong-Ki Hong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Cardiology, Severance Hospital, Yonsei University College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Myeong-Ki Hong, MD, PhD</last_name>
    <phone>82-2-2228-8458</phone>
    <email>mkhong61@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Myeong-Ki Hong, MD, PhD</last_name>
      <phone>82-2-2228-8458</phone>
      <email>mkhong61@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 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 Artery Disease</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Acute Disease</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/NCT03797651
org study id: 4-2018-0782
nct id: NCT03797651
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events
      without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor
      monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will
      also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary
      syndrome. After confirmation of enrollment, patients will be randomized to continue standard
      treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less
      than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according
      to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline
      clinical and angiographic characteristics, laboratory findings will be assessed at the time
      of randomization. All patients will provide informed consent on their own initiative.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Net clinical benefit
time frame: 1 year after procedure
description: A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding
measure: Each components of net clinical benefit
time frame: 1 year after procedure
description: All-cause death, MI, stent thrombosis, stroke, major bleeding
measure: Cardiovascular mortality
time frame: 1 year after procedure
description: Cardiovascular mortality
measure: Major or minor bleeding
time frame: 1 year after procedure
description: Major or minor bleeding
measure: Major adverse cardiac event
time frame: 1 year after procedure
description: A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization
arm group label: Standard DAPT
arm group type: Active Comparator
description: Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.
arm group label: Very-short DAPT within 1 month
arm group type: Experimental
description: Patient will stop aspirin after discharge (DAPT less than 1 months after PCI) (ticagrelor monotherapy). Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).
intervention type: Drug
intervention name: Standard DAPT
description: Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.
arm group label: Standard DAPT
intervention type: Drug
intervention name: Very-short DAPT less than 1 month after PCI
description: Patient will stop aspirin (ticagrelor monotherapy) after discharge or within 1 month. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).
arm group label: Very-short DAPT within 1 month
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Myeong-Ki Hong
role: Principal Investigator
affiliation: Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
last name: Myeong-Ki Hong, MD, PhD
phone: 82-2-2228-8458
email: mkhong61@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Acute Disease
sharing ipd: Undecided