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/NCT05978726</url>
    </required_header>
    <id_info>
      <org_study_id>2023007</org_study_id>
      <nct_id>NCT05978726</nct_id>
    </id_info>
    <brief_title>Ticagrelor Versus Clopidogrel for CMD in Patients With AMI: A Retrospective Study Based on the Angio-IMR</brief_title>
    <official_title>Ticagrelor Versus Clopidogrel for Coronary Microvascular Dysfunction in Patients With Acute Myocardial Infarction: A Retrospective Study Based on the Angiography-derived Index of Microcirculatory Resistance</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</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>
        Coronary microvascular dysfunction (CMD) is increasingly recognized as an important indicator&#xD;
        for long-term prognosis in patients with acute myocardial infarction (AMI). The&#xD;
        angiography-derived index of microcirculatory resistance (angio-IMR) is a novel&#xD;
        guidewire-free measure for CMD in patients with AMI. Ticagrelor has recently been suggested&#xD;
        to have additional benefits on coronary microcirculation beyond its antiplatelet effect. This&#xD;
        study was designed to compare the protective effects of ticagrelor and clopidogrel on CMD and&#xD;
        prognostic impact in patients with AMI, using the angio-IMR as a novel assessment tool.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2017</start_date>
    <completion_date type="Actual">May 30, 2022</completion_date>
    <primary_completion_date type="Actual">May 30, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The improvement of angio-IMR</measure>
      <time_frame>within 24 months post-PCI</time_frame>
      <description>Difference between Angio-IMR at follow-up coronary angiography and Angio-IMR after PCI</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Readmission for heart failure</measure>
      <time_frame>Within 24 months post-PCI</time_frame>
      <description>Readmission for an acute exacerbation of chronic heart failure or acute heart failure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Myocardial reinfarction</measure>
      <time_frame>Within 24 months post-PCI</time_frame>
      <description>Another myocardial infarction with elevated myocardial enzymes and abnormal electrocardiograms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target vessel revascularization</measure>
      <time_frame>Within 24 months post-PCI</time_frame>
      <description>Repeat revascularization was performed because of ischemia in the target-vessel territory</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-target vessel revascularization</measure>
      <time_frame>Within 24 months post-PCI</time_frame>
      <description>Repeat revascularization was performed because of ischemia in the non-target vessel territory</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cerebral hemorrhage</measure>
      <time_frame>Within 24 months post-PCI</time_frame>
      <description>The occurrence of cerebral hemorrhage during the follow-up period was based on imaging CT and MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Other bleeding events</measure>
      <time_frame>Within 24 months post-PCI</time_frame>
      <description>Bleeding events such as gingival bleeding, skin bleeding, and gastrointestinal bleeding and so on, occurred during the follow-up period</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">325</enrollment>
    <condition>Coronary Heart Disease</condition>
    <arm_group>
      <arm_group_label>ticagrelor maintenance treatment group</arm_group_label>
      <description>Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and ticagrelor 90mg twice daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>clopidogrel maintenance treatment group</arm_group_label>
      <description>Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and clopidogrel 75mg once daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel</intervention_name>
      <description>Patients with acute myocardial infarction randomly received dual antiplatelet therapy with with aspirin 100mg daily and either ticagrelor 90mg twice daily or clopidogrel 75mg once daily for at least 9 months after PCI as needed.</description>
      <arm_group_label>ticagrelor maintenance treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          We retrospectively enrolled patients who were diagnosed with AMI, including STEMI and&#xD;
          NSTEMI, and underwent successful PCI and routine follow-up coronary angiography at the&#xD;
          Second Affiliated Hospital of Zhejiang University School of Medicine between June 1, 2017&#xD;
          and May 31, 2020. The diagnosis of AMI was based on current clinical guidelines. All&#xD;
          patients were pretreated with oral aspirin 300mg and a loading dose of ticagrelor 180mg or&#xD;
          clopidogrel 300mg before PCI. Patients received dual antiplatelet therapy (DAPT) with&#xD;
          aspirin 100mg daily and either ticagrelor 90mg twice daily or clopidogrel 75mg once daily&#xD;
          for at least 9 months after PCI. Patients were divided into clopidogrel group and&#xD;
          ticagrelor group according to the post-PCI antiplatelet maintenance therapy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who were diagnosed with AMI, including STEMI and NSTEMI, and underwent&#xD;
               successful PCI and routine follow-up coronary angiography at the Second Affiliated&#xD;
               Hospital of Zhejiang University School of Medicine between June 1, 2017 and May 31,&#xD;
               2020.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1) prior treatment with any P2Y12 inhibitor;&#xD;
  &#xD;
            -  2) need for long-term oral anticoagulation therapy;&#xD;
  &#xD;
            -  3) previous coronary artery bypass grafting (CABG);&#xD;
  &#xD;
            -  4) chronic renal dysfunction with estimated glomerular filtration rate (eGFR) &lt;30 mL/&#xD;
               (min·1.73 m2) or on hemodialysis;&#xD;
  &#xD;
            -  5) liver cirrhosis ≥Child-Pugh B class;&#xD;
  &#xD;
            -  6) cancer;&#xD;
  &#xD;
            -  7) adjustment of dual antiplatelet therapy (DAPT) during follow-up;&#xD;
  &#xD;
            -  8) inadequate coronary angiographic images.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Jun Jiang, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Second affiliated Hospital Zhejiang University School of Medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Second affiliated Hospital Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310009</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Jiang J, Li C, Hu Y, Li C, He J, Leng X, Xiang J, Ge J, Wang J. A novel CFD-based computed index of microcirculatory resistance (IMR) derived from coronary angiography to assess coronary microcirculation. Comput Methods Programs Biomed. 2022 Jun;221:106897. doi: 10.1016/j.cmpb.2022.106897. Epub 2022 May 18.</citation>
      <PMID>35636354</PMID>
    </reference>
    <reference>
      <citation>Choi KH, Dai N, Li Y, Kim J, Shin D, Lee SH, Joh HS, Kim HK, Jeon KH, Ha SJ, Kim SM, Jang MJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Choi SH, Gwon HC, Lee JM. Functional Coronary Angiography-Derived Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1670-1684. doi: 10.1016/j.jcin.2021.05.027. Erratum In: JACC Cardiovasc Interv. 2022 Oct 10;15(19):2001.</citation>
      <PMID>34353599</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 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>Heart Diseases</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aspirin</mesh_term>
      <mesh_term>Clopidogrel</mesh_term>
      <mesh_term>Ticagrelor</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05978726
  org study id: 2023007
  nct id: NCT05978726
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Coronary microvascular dysfunction (CMD) is increasingly recognized as an important indicator
        for long-term prognosis in patients with acute myocardial infarction (AMI). The
        angiography-derived index of microcirculatory resistance (angio-IMR) is a novel
        guidewire-free measure for CMD in patients with AMI. Ticagrelor has recently been suggested
        to have additional benefits on coronary microcirculation beyond its antiplatelet effect. This
        study was designed to compare the protective effects of ticagrelor and clopidogrel on CMD and
        prognostic impact in patients with AMI, using the angio-IMR as a novel assessment tool.
  observational model: Cohort
  time perspective: Retrospective
  measure: The improvement of angio-IMR
  time frame: within 24 months post-PCI
  description: Difference between Angio-IMR at follow-up coronary angiography and Angio-IMR after PCI
  measure: Readmission for heart failure
  time frame: Within 24 months post-PCI
  description: Readmission for an acute exacerbation of chronic heart failure or acute heart failure
  measure: Myocardial reinfarction
  time frame: Within 24 months post-PCI
  description: Another myocardial infarction with elevated myocardial enzymes and abnormal electrocardiograms
  measure: Target vessel revascularization
  time frame: Within 24 months post-PCI
  description: Repeat revascularization was performed because of ischemia in the target-vessel territory
  measure: Non-target vessel revascularization
  time frame: Within 24 months post-PCI
  description: Repeat revascularization was performed because of ischemia in the non-target vessel territory
  measure: Cerebral hemorrhage
  time frame: Within 24 months post-PCI
  description: The occurrence of cerebral hemorrhage during the follow-up period was based on imaging CT and MRI
  measure: Other bleeding events
  time frame: Within 24 months post-PCI
  description: Bleeding events such as gingival bleeding, skin bleeding, and gastrointestinal bleeding and so on, occurred during the follow-up period
  arm group label: ticagrelor maintenance treatment group
  description: Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and ticagrelor 90mg twice daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography.
  arm group label: clopidogrel maintenance treatment group
  description: Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and clopidogrel 75mg once daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography.
  intervention type: Drug
  intervention name: Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel
  description: Patients with acute myocardial infarction randomly received dual antiplatelet therapy with with aspirin 100mg daily and either ticagrelor 90mg twice daily or clopidogrel 75mg once daily for at least 9 months after PCI as needed.
  arm group label: ticagrelor maintenance treatment group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  last name: Jun Jiang, MD, PhD
  role: Study Director
  affiliation: Second affiliated Hospital Zhejiang University School of Medicine
  facility: 
  country: China
  citation: Jiang J, Li C, Hu Y, Li C, He J, Leng X, Xiang J, Ge J, Wang J. A novel CFD-based computed index of microcirculatory resistance (IMR) derived from coronary angiography to assess coronary microcirculation. Comput Methods Programs Biomed. 2022 Jun;221:106897. doi: 10.1016/j.cmpb.2022.106897. Epub 2022 May 18.
  PMID: 35636354
  citation: Choi KH, Dai N, Li Y, Kim J, Shin D, Lee SH, Joh HS, Kim HK, Jeon KH, Ha SJ, Kim SM, Jang MJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Choi SH, Gwon HC, Lee JM. Functional Coronary Angiography-Derived Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1670-1684. doi: 10.1016/j.jcin.2021.05.027. Erratum In: JACC Cardiovasc Interv. 2022 Oct 10;15(19):2001.
  PMID: 34353599
  responsible party type: Sponsor
  mesh term: Heart Diseases
  mesh term: Coronary Disease
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Aspirin
  mesh term: Clopidogrel
  mesh term: Ticagrelor
  sharing ipd: Undecided