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/NCT05986968</url>
    </required_header>
    <id_info>
      <org_study_id>NL82646.091.22</org_study_id>
      <nct_id>NCT05986968</nct_id>
    </id_info>
    <brief_title>The Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage</brief_title>
    <acronym>STOP-IMH</acronym>
    <official_title>The Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Radboud University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Radboud University Medical Center</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 main goal of this clinical trial is to assess the safety of direct omission of aspirin&#xD;
        after Percutaneous Coronary Intervention (PCI) in patients with ST elevation myocardial&#xD;
        infarction (STEMI). The secondary objectives are to demonstrate the reduction of&#xD;
        intramyocardial haemorrhage and infarct size, which will be measured after 1 week; to compare&#xD;
        clinical bleeding outcomes and to compare platelet reactivity and inflammatory response in&#xD;
        STEMI patients receiving ticagrelor monotherapy versus dual antiplatelet therapy.&#xD;
  &#xD;
        Patients will be treated with either ticagrelor monotherapy or dual antiplatelet therapy&#xD;
        (aspirin plus ticagrelor) after PCI. They will be compared to see if the omission of aspirin&#xD;
        is safe in terms of major adverse cardiac and cerebral events at 13 months follow-up.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">July 6, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 6, 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>Composite of major adverse cardiac and cerebral events (MACCE)</measure>
      <time_frame>13 months</time_frame>
      <description>Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intramyocardial haemorrhage (IMH)</measure>
      <time_frame>day 5-8 post PCI</time_frame>
      <description>Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post-PCI.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bleeding complications</measure>
      <time_frame>13 months</time_frame>
      <description>Defined as Bleeding Academic Research Consortium (BARC) 2 or greater</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>13 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Platelet reactivity of aspirin measured as Aspirin Reaction Units (ARU) using the VerifyNow test</measure>
      <time_frame>5-8 days</time_frame>
      <description>Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>ST Elevation Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>Treatment arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ticagrelor</intervention_name>
      <description>Ticagrelor monotherapy for 12 months</description>
      <arm_group_label>Control arm</arm_group_label>
      <arm_group_label>Treatment arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aspirin</intervention_name>
      <description>Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months</description>
      <arm_group_label>Control arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical and electrocardiographical diagnosis of STEMI&#xD;
  &#xD;
            -  Successful PCI (according to the treating physician) of the infarct-related vessel&#xD;
               with a modern DES&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known allergy or contraindication for aspirin, ticagrelor or prasugrel.&#xD;
  &#xD;
            -  Previous PCI or MI less than 12 months ago&#xD;
  &#xD;
            -  Previous cardiac surgery&#xD;
  &#xD;
            -  Participation in another clinical cardiology study or study concerning platelet&#xD;
               aggregation/ thrombosis.&#xD;
  &#xD;
            -  Pregnancy and breast feeding&#xD;
  &#xD;
            -  Concurrent use of oral anticoagulants (OAC)&#xD;
  &#xD;
            -  The periprocedural use of GPIIb/IIIa inhibitors&#xD;
  &#xD;
            -  Planned surgical intervention within 12 months of PCI&#xD;
  &#xD;
            -  Creatinine clearance &lt;30mL/min or dialysis&#xD;
  &#xD;
            -  PCI of stent thrombosis&#xD;
  &#xD;
            -  Suboptimal stent result as judged by the interventional cardiologist.&#xD;
  &#xD;
            -  Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR&#xD;
               subgroup population).&#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_contact>
      <last_name>Peter Damman, MD, PhD, FESC</last_name>
      <phone>0031243616785</phone>
      <email>peter.damman@radboudumc.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Noordwest Ziekenhuisgroep Alkmaar</name>
        <address>
          <city>Alkmaar</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Maurits Dirksen, MD, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Amsterdam UMC</name>
        <address>
          <city>Amsterdam</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Bimmer Claessen, MD, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Medisch Spectrum Twente</name>
        <address>
          <city>Enschede</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Clemens Von Birgelen, MD, Prof</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Medisch Centrum Leeuwarden</name>
        <address>
          <city>Leeuwarden</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Pier Woudstra, MD, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Radboudumc</name>
        <address>
          <city>Nijmegen</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peter Damman, MD, PhD, FESC</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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>Myocardial Infarction</mesh_term>
      <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
      <mesh_term>Infarction</mesh_term>
      <mesh_term>Hemorrhage</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>
    <!-- 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/NCT05986968
  org study id: NL82646.091.22
  nct id: NCT05986968
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The main goal of this clinical trial is to assess the safety of direct omission of aspirin
        after Percutaneous Coronary Intervention (PCI) in patients with ST elevation myocardial
        infarction (STEMI). The secondary objectives are to demonstrate the reduction of
        intramyocardial haemorrhage and infarct size, which will be measured after 1 week; to compare
        clinical bleeding outcomes and to compare platelet reactivity and inflammatory response in
        STEMI patients receiving ticagrelor monotherapy versus dual antiplatelet therapy.
  
        Patients will be treated with either ticagrelor monotherapy or dual antiplatelet therapy
        (aspirin plus ticagrelor) after PCI. They will be compared to see if the omission of aspirin
        is safe in terms of major adverse cardiac and cerebral events at 13 months follow-up.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Composite of major adverse cardiac and cerebral events (MACCE)
  time frame: 13 months
  description: Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality
  measure: Intramyocardial haemorrhage (IMH)
  time frame: day 5-8 post PCI
  description: Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post-PCI.
  measure: Bleeding complications
  time frame: 13 months
  description: Defined as Bleeding Academic Research Consortium (BARC) 2 or greater
  measure: All-cause mortality
  time frame: 13 months
  measure: Platelet reactivity of aspirin measured as Aspirin Reaction Units (ARU) using the VerifyNow test
  time frame: 5-8 days
  description: Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured
  arm group label: Treatment arm
  arm group type: Experimental
  description: Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)
  arm group label: Control arm
  arm group type: Active Comparator
  description: Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.
  intervention type: Drug
  intervention name: Ticagrelor
  description: Ticagrelor monotherapy for 12 months
  arm group label: Control arm
  arm group label: Treatment arm
  intervention type: Drug
  intervention name: Aspirin
  description: Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months
  arm group label: Control arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Peter Damman, MD, PhD, FESC
  phone: 0031243616785
  email: peter.damman@radboudumc.nl
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Myocardial Infarction
  mesh term: ST Elevation Myocardial Infarction
  mesh term: Infarction
  mesh term: Hemorrhage
  mesh term: Aspirin
  mesh term: Ticagrelor