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/NCT05967663</url>
    </required_header>
    <id_info>
      <org_study_id>Non-IRA Study</org_study_id>
      <nct_id>NCT05967663</nct_id>
    </id_info>
    <brief_title>Immediate Versus Staged Complete Myocardial Revascularization in Patients With STEMI With Multivessel Disease</brief_title>
    <official_title>Immediate Versus Staged Complete Revascularisation in ST-segment-elevation Myocardial Infarction Patients With Multivessel Coronary Disease: a Prospective, Open-label, Non-inferiority, Randomised Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</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>
        It is a prospective, multicenter, randomised controlled, open-label, blinded endpoint&#xD;
        assessment trial, to compare the strategy of immediate complete revascularisation and staged&#xD;
        complete revascularisation in ST-segment-elevation myocardial infarction patients with&#xD;
        multivessel coronary disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives: The purpose of this study is to compare the strategy of immediate complete&#xD;
        revascularisation and staged complete revascularisation in ST-segment-elevation myocardial&#xD;
        infarction patients with multivessel coronary disease.&#xD;
  &#xD;
        Inclusion Criteria:&#xD;
  &#xD;
          1. Age ≥ 18 years&#xD;
  &#xD;
          2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of the&#xD;
             culprit lesion (including those who still have ischemic symptoms within 48 hours)&#xD;
  &#xD;
          3. Multivessel disease was defined at least one coronary arteries with a diameter of 2.5 mm&#xD;
             or more and a maximum diameter at least 70% stenosis by visual estimation or a maximum&#xD;
             diameter stenosis rate of 70%, without prior stent implantation, PCI can be successfully&#xD;
             implemented.&#xD;
  &#xD;
          4. Sign an informed consent form before participating in the study The standard for acute&#xD;
             myocardial infarction follows the &quot;Fourth Edition of the General Definition of Acute ST&#xD;
             Segment Elevated Myocardial Infarction&quot; released by ESC/ACC/AHA/WHF in 2018. STEMI is&#xD;
             defined as: 1) typical ischemic symptoms; 2) On the adjacent two leads, the ST segment&#xD;
             elevation at the newly detected J-point is accompanied by a cutoff point: ≥ 2mm on all&#xD;
             leads except for the V2-V3 lead; In the V2-V3 lead, the following cutoff points are&#xD;
             used: ≥ 2mm (males ≥ 40 years old), ≥ 2.5 mm (males &lt; 40 year old); Women regardless of&#xD;
             age ≥ 1.5 mm; 3) Troponin increased, and the measured value was greater than the upper&#xD;
             reference limit of 99th percentile at least once.&#xD;
  &#xD;
        Exclusion Criteria:&#xD;
  &#xD;
          1. Received thrombolytic therapy&#xD;
  &#xD;
          2. Cardiac shock or SBP&lt;90mmHg;&#xD;
  &#xD;
          3. History of old myocardial infarction;&#xD;
  &#xD;
          4. Left main artery lesion, non infarct related vessels are CTO lesions;&#xD;
  &#xD;
          5. PCI in the previous 30 days or Previous CABG&#xD;
  &#xD;
          6. Patients who cannot give informed consent or have a life expectancy of less than 1 year&#xD;
  &#xD;
          7. Patients combined with other serious diseases such as severe renal dysfunction&#xD;
             (creatinine clearance value&lt;30ml/min;), liver dysfunction and thrombocytopenia&#xD;
  &#xD;
          8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive&#xD;
             cardiomyopathy, and primary pulmonary hypertension;&#xD;
  &#xD;
          9. Not suitable for clinical research:&#xD;
  &#xD;
               1. . Currently participating in another study that may affect the primary endpoint&#xD;
  &#xD;
               2. . Pregnant and lactating women;&#xD;
  &#xD;
               3. . Known allergy to drugs that may be used in the study;&#xD;
  &#xD;
               4. . Unable to comply with the trial protocol or follow-up requirements; Or the&#xD;
                  researcher believes that participating in the trial may result in patients facing&#xD;
                  greater risks; Or the researcher believes that the inclusion of the subject may&#xD;
                  affect the special evaluation of the experiment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">December 2026</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>MACCE</measure>
      <time_frame>At 1 year after the index procedure</time_frame>
      <description>The composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>MACCE</measure>
      <time_frame>At 1 months, 6 months, 2 and 3 years after the index procedure</time_frame>
      <description>The composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>At 1 months, 6 months, 1, 2 and 3 years after the index procedure</time_frame>
      <description>All-cause mortality (cardiovascular death, non- cardiovascular death, undetermined cause of death)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular death</measure>
      <time_frame>At 1 months, 6 months, 1, 2 and 3 years after the index procedure</time_frame>
      <description>Cardiovascular death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Myocardial Infarction</measure>
      <time_frame>At 1 months, 6 months, 1, 2 and 3 years after the index procedure</time_frame>
      <description>Myocardial Infarction (Q-wave and non Q-wave MI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TVR: Target vessel revascularization</measure>
      <time_frame>At 1 months, 6 months, 1, 2 and 3 years after the index procedure</time_frame>
      <description>TVR: Target vessel revascularization(Ischemia driven revascularization, or Non ischemic driven revascularization)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Any coronary revascularization</measure>
      <time_frame>At 1 months, 6 months, 1, 2 and 3 years after the index procedure</time_frame>
      <description>Any coronary revascularization (ischemic driven, non ischemic driven)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stent Thrombosis</measure>
      <time_frame>At 1 months, 6 months, 1, 2 and 3 years after the index procedure</time_frame>
      <description>ARC-2 defines Stent Thrombosis: including confirmed and possible stent thrombosis within acute, subacute, and advanced time ranges</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cerebrovascular events</measure>
      <time_frame>At 1 months, 6 months, 1, 2 and 3 years after the index procedure</time_frame>
      <description>Cerebrovascular events (Ischemic\hemorrhagic)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Contrast-induced acute kidney injury</measure>
      <time_frame>At 1 months after the index procedure</time_frame>
      <description>Contrast-induced acute kidney injury</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Major bleeding</measure>
      <time_frame>At 1 months, 6 months, 1, 2 and 3 years after the index procedure</time_frame>
      <description>Major bleeding (BARC 3-5)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1608</enrollment>
    <condition>ST Elevation Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Immediate complete revascularisation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Staged complete revascularisation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PCI</intervention_name>
      <description>In patients allocated to the immediate complete revascularisation group, PCI of the culprit lesion was attempted first and followed by all other lesions deemed to be clinically significant by the operator during the index procedure. In the staged complete revascularisation group, only the culprit lesion was treated during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator was planned at a later stage through an elective re-admission within 45 days after the index procedure.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years&#xD;
  &#xD;
            2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of&#xD;
               the culprit lesion (including those who still have ischemic symptoms within 48 hours)&#xD;
  &#xD;
            3. Multivessel disease was defined at least one coronary arteries with a diameter of 2.5&#xD;
               mm or more and a maximum diameter at least 70% stenosis by visual estimation or a&#xD;
               maximum diameter stenosis rate of 70%, without prior stent implantation, PCI can be&#xD;
               successfully implemented.&#xD;
  &#xD;
            4. Sign an informed consent form before participating in the study&#xD;
  &#xD;
          The standard for acute myocardial infarction follows the &quot;Fourth Edition of the General&#xD;
          Definition of Acute ST Segment Elevated Myocardial Infarction&quot; released by ESC/ACC/AHA/WHF&#xD;
          in 2018. STEMI is defined as: 1) typical ischemic symptoms; 2) On the adjacent two leads,&#xD;
          the ST segment elevation at the newly detected J-point is accompanied by a cutoff point: ≥&#xD;
          2mm on all leads except for the V2-V3 lead; In the V2-V3 lead, the following cutoff points&#xD;
          are used: ≥ 2mm (males ≥ 40 years old), ≥ 2.5 mm (males &lt; 40 year old); Women regardless of&#xD;
          age ≥ 1.5 mm; 3) Troponin increased, and the measured value was greater than the upper&#xD;
          reference limit of 99th percentile at least once.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Received thrombolytic therapy&#xD;
  &#xD;
            2. Cardiac shock or SBP&lt;90mmHg;&#xD;
  &#xD;
            3. History of old myocardial infarction;&#xD;
  &#xD;
            4. Left main artery lesion, non infarct related vessels are CTO lesions;&#xD;
  &#xD;
            5. PCI in the previous 30 days or Previous CABG&#xD;
  &#xD;
            6. Patients who cannot give informed consent or have a life expectancy of less than 1&#xD;
               year&#xD;
  &#xD;
            7. Patients combined with other serious diseases such as severe renal dysfunction&#xD;
               (creatinine clearance value&lt;30ml/min;), liver dysfunction and thrombocytopenia&#xD;
  &#xD;
            8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive&#xD;
               cardiomyopathy, and primary pulmonary hypertension;&#xD;
  &#xD;
            9. Not suitable for clinical research:&#xD;
  &#xD;
                 1. Currently participating in another study that may affect the primary endpoint&#xD;
  &#xD;
                 2. Pregnant and lactating women;&#xD;
  &#xD;
                 3. Known allergy to drugs that may be used in the study;&#xD;
  &#xD;
                 4. Unable to comply with the trial protocol or follow-up requirements; Or the&#xD;
                    researcher believes that participating in the trial may result in patients facing&#xD;
                    greater risks; Or the researcher believes that the inclusion of the subject may&#xD;
                    affect the special evaluation of the experiment.&#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>Jun Pu, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jun Pu, MD, PhD</last_name>
      <phone>86-21-68383477</phone>
      <email>pujun310@hotmail.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>STEMI</keyword>
    <keyword>Coronary Artery Disease</keyword>
    <keyword>Coronary Syndrome</keyword>
    <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>
    </condition_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/NCT05967663
  org study id: Non-IRA Study
  nct id: NCT05967663
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  It is a prospective, multicenter, randomised controlled, open-label, blinded endpoint
        assessment trial, to compare the strategy of immediate complete revascularisation and staged
        complete revascularisation in ST-segment-elevation myocardial infarction patients with
        multivessel coronary disease.
  Objectives: The purpose of this study is to compare the strategy of immediate complete
        revascularisation and staged complete revascularisation in ST-segment-elevation myocardial
        infarction patients with multivessel coronary disease.
  
        Inclusion Criteria:
  
          1. Age ≥ 18 years
  
          2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of the
             culprit lesion (including those who still have ischemic symptoms within 48 hours)
  
          3. Multivessel disease was defined at least one coronary arteries with a diameter of 2.5 mm
             or more and a maximum diameter at least 70% stenosis by visual estimation or a maximum
             diameter stenosis rate of 70%, without prior stent implantation, PCI can be successfully
             implemented.
  
          4. Sign an informed consent form before participating in the study The standard for acute
             myocardial infarction follows the "Fourth Edition of the General Definition of Acute ST
             Segment Elevated Myocardial Infarction" released by ESC/ACC/AHA/WHF in 2018. STEMI is
             defined as: 1) typical ischemic symptoms; 2) On the adjacent two leads, the ST segment
             elevation at the newly detected J-point is accompanied by a cutoff point: ≥ 2mm on all
             leads except for the V2-V3 lead; In the V2-V3 lead, the following cutoff points are
             used: ≥ 2mm (males ≥ 40 years old), ≥ 2.5 mm (males < 40 year old); Women regardless of
             age ≥ 1.5 mm; 3) Troponin increased, and the measured value was greater than the upper
             reference limit of 99th percentile at least once.
  
        Exclusion Criteria:
  
          1. Received thrombolytic therapy
  
          2. Cardiac shock or SBP<90mmHg;
  
          3. History of old myocardial infarction;
  
          4. Left main artery lesion, non infarct related vessels are CTO lesions;
  
          5. PCI in the previous 30 days or Previous CABG
  
          6. Patients who cannot give informed consent or have a life expectancy of less than 1 year
  
          7. Patients combined with other serious diseases such as severe renal dysfunction
             (creatinine clearance value<30ml/min;), liver dysfunction and thrombocytopenia
  
          8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive
             cardiomyopathy, and primary pulmonary hypertension;
  
          9. Not suitable for clinical research:
  
               1. . Currently participating in another study that may affect the primary endpoint
  
               2. . Pregnant and lactating women;
  
               3. . Known allergy to drugs that may be used in the study;
  
               4. . Unable to comply with the trial protocol or follow-up requirements; Or the
                  researcher believes that participating in the trial may result in patients facing
                  greater risks; Or the researcher believes that the inclusion of the subject may
                  affect the special evaluation of the experiment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: MACCE
  time frame: At 1 year after the index procedure
  description: The composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events
  measure: MACCE
  time frame: At 1 months, 6 months, 2 and 3 years after the index procedure
  description: The composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events
  measure: All-cause mortality
  time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
  description: All-cause mortality (cardiovascular death, non- cardiovascular death, undetermined cause of death)
  measure: Cardiovascular death
  time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
  description: Cardiovascular death
  measure: Myocardial Infarction
  time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
  description: Myocardial Infarction (Q-wave and non Q-wave MI)
  measure: TVR: Target vessel revascularization
  time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
  description: TVR: Target vessel revascularization(Ischemia driven revascularization, or Non ischemic driven revascularization)
  measure: Any coronary revascularization
  time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
  description: Any coronary revascularization (ischemic driven, non ischemic driven)
  measure: Stent Thrombosis
  time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
  description: ARC-2 defines Stent Thrombosis: including confirmed and possible stent thrombosis within acute, subacute, and advanced time ranges
  measure: Cerebrovascular events
  time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
  description: Cerebrovascular events (Ischemic\hemorrhagic)
  measure: Contrast-induced acute kidney injury
  time frame: At 1 months after the index procedure
  description: Contrast-induced acute kidney injury
  measure: Major bleeding
  time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
  description: Major bleeding (BARC 3-5)
  arm group label: Intervention group
  arm group type: Experimental
  description: Immediate complete revascularisation
  arm group label: Control group
  arm group type: Active Comparator
  description: Staged complete revascularisation
  intervention type: Device
  intervention name: PCI
  description: In patients allocated to the immediate complete revascularisation group, PCI of the culprit lesion was attempted first and followed by all other lesions deemed to be clinically significant by the operator during the index procedure. In the staged complete revascularisation group, only the culprit lesion was treated during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator was planned at a later stage through an elective re-admission within 45 days after the index procedure.
  arm group label: Control group
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jun Pu, MD, PhD
  role: Principal Investigator
  affiliation: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  last name: Jun Pu, MD, PhD
  phone: 86-21-68383477
  email: pujun310@hotmail.com
  responsible party type: Sponsor
  mesh term: Myocardial Infarction
  mesh term: ST Elevation Myocardial Infarction
  mesh term: Infarction