<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/NCT03787745</url>
  </required_header>
  <id_info>
    <org_study_id>H-18051256</org_study_id>
    <nct_id>NCT03787745</nct_id>
  </id_info>
  <brief_title>Ischemic Postconditioning in STEMI Patients Treated With Primary PCI</brief_title>
  <acronym>iPOST2</acronym>
  <official_title>The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI (DANAMI4-iPOST2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</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>
      In a prospective, randomized clinical trial the iPOST2 trial will determine whether ischemic&#xD;
      postconditioning reduces reperfusion injury and this will translate into improved clinical&#xD;
      outcome of heart failure and death for STEMI patients who present with TIMI0-1 undergoing&#xD;
      primary PCI&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myocardial reperfusion with the use primary percutaneous coronary intervention (PCI) is&#xD;
      effective, but restoration of blood flow may itself jeopardize the myocardium, a phenomenon&#xD;
      known as reperfusion injury.&#xD;
&#xD;
      In ischemic postconditioning (iPOST), repetitive interruptions of blood flow to the injured&#xD;
      region applied after initial reperfusion, has been shown favorable with different modalities&#xD;
      such as biomarkers, echocardiography and cardiac magnetic resonance.&#xD;
&#xD;
      However, the largest trial to date (DANAMI3-iPOST) failed to show clinical favor of iPOST&#xD;
      when compared to conventional PCI. Importantly, however, in DANAMI3-iPOST thrombectomy was&#xD;
      allowed and this might have impaired postconditioning, since thrombectomy itself creates&#xD;
      reperfusion and thus reperfusion damage. Analysis of the fraction of DANAMI3-iPOST patients&#xD;
      not undergoing thrombectomy showed a remarkable 45% reduction in death and heart failure in&#xD;
      favor of postconditioning.&#xD;
&#xD;
      iPOST2 will investigate in a randomized, prospective and adequately powered trial the effect&#xD;
      of iPOST without thrombectomy compared to conventional PCI on the development of heart&#xD;
      failure and death in STEMI patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2033</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</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>
    <intervention_model_description>Prospective, randomized, placebo controlled</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>All study personell involved in outcome assessment will be blinded to the treatment employed</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>All cause mortality or hospitalization for heart failure</measure>
    <time_frame>From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months</time_frame>
    <description>Composite endpoint of all cause mortality or hospitalization for heart failure which ever occur first</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>From date of randomization until the date of first documented death from any cause assessed up to 280 events have been adjudicated or up to 36 months</time_frame>
    <description>All cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients hospitalized for heart failure</measure>
    <time_frame>From date of randomization until the date of first documented hospitalization for heart failure assessed up to 280 events have been adjudicated or up to 36 months</time_frame>
    <description>Any hospitalization for heart failure occurring after the index STEMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with myocardial infarction</measure>
    <time_frame>From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months</time_frame>
    <description>Any myocardial infarction occurring after the index STEMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months</time_frame>
    <description>Cardiovascular death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with stroke</measure>
    <time_frame>From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months</time_frame>
    <description>An acute episode of focal or global neurological dysfunction caused by brain injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with a combination of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia</measure>
    <time_frame>From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months</time_frame>
    <description>Composite endpoint of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with a combination of hospitalization for heart failure and cardiovascular death</measure>
    <time_frame>From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months</time_frame>
    <description>A composite of hospitalization for heart failure and cardiovascular death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Danish eq5d5l standard Quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>Self assesed quality of life after the Danish eq5d5l standard scale (1 worst score -100 best score)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>ST Segment Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Ischemic postconditioning</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to state of the art primary PCI in patients with TIMI0-1 ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed, however thrombectomy will not be allowed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>State of the art primary PCI in patients with TIMI0-1 will be performed, however thrombectomy will not be allowed</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ischemic postconditioning</intervention_name>
    <description>After 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed</description>
    <arm_group_label>Ischemic postconditioning</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional</intervention_name>
    <description>State of the art primary PCI, however thrombectomy is not allowed</description>
    <arm_group_label>Conventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Acute onset of chest pain with &lt; 12 hours duration&#xD;
&#xD;
          -  STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or&#xD;
             presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or&#xD;
             1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST&#xD;
             depression in 2 or more V1 through V4 leads indicating posterior AMI.&#xD;
&#xD;
          -  TIMI flow 0-1 in infarct related artery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Potential pregnancy&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  OHCA without subsequent consciousness despite ROSC&#xD;
&#xD;
          -  Thrombectomy considered unavoidable&#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>Thomas Engstrøm, DMSci</last_name>
    <role>Study Chair</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Engstrøm, DMSci</last_name>
    <phone>+4535458444</phone>
    <email>thomas.engstroem@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jacob Lønborg, DMSci</last_name>
    <phone>+4535458176</phone>
    <email>jacob.thomsen.loenborg01@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Heart Center, Rigshospitalet, University of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Engstrøm, DMSci</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <results_reference>
    <citation>Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Clemmensen P, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Ravkilde J, Tilsted HH, Villadsen A, Aaroe J, Jensen SE, Raungaard B, Botker HE, Terkelsen CJ, Maeng M, Kaltoft A, Krusell LR, Jensen LO, Veien KT, Kofoed KF, Torp-Pedersen C, Kyhl K, Nepper-Christensen L, Treiman M, Vejlstrup N, Ahtarovski K, Lonborg J, Kober L; Third Danish Study of Optimal Acute Treatment of Patients With ST Elevation Myocardial Infarction-Ischemic Postconditioning (DANAMI-3-iPOST) Investigators. Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):490-497. doi: 10.1001/jamacardio.2017.0022.</citation>
    <PMID>28249094</PMID>
  </results_reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Thomas Engstrom</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Primary PCI</keyword>
  <keyword>Ischemic postconditioning</keyword>
  <keyword>Clinical outcome</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>
  <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/NCT03787745
org study id: H-18051256
nct id: NCT03787745
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In a prospective, randomized clinical trial the iPOST2 trial will determine whether ischemic
      postconditioning reduces reperfusion injury and this will translate into improved clinical
      outcome of heart failure and death for STEMI patients who present with TIMI0-1 undergoing
      primary PCI
Myocardial reperfusion with the use primary percutaneous coronary intervention (PCI) is
      effective, but restoration of blood flow may itself jeopardize the myocardium, a phenomenon
      known as reperfusion injury.

      In ischemic postconditioning (iPOST), repetitive interruptions of blood flow to the injured
      region applied after initial reperfusion, has been shown favorable with different modalities
      such as biomarkers, echocardiography and cardiac magnetic resonance.

      However, the largest trial to date (DANAMI3-iPOST) failed to show clinical favor of iPOST
      when compared to conventional PCI. Importantly, however, in DANAMI3-iPOST thrombectomy was
      allowed and this might have impaired postconditioning, since thrombectomy itself creates
      reperfusion and thus reperfusion damage. Analysis of the fraction of DANAMI3-iPOST patients
      not undergoing thrombectomy showed a remarkable 45% reduction in death and heart failure in
      favor of postconditioning.

      iPOST2 will investigate in a randomized, prospective and adequately powered trial the effect
      of iPOST without thrombectomy compared to conventional PCI on the development of heart
      failure and death in STEMI patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, placebo controlled
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: All study personell involved in outcome assessment will be blinded to the treatment employed
measure: All cause mortality or hospitalization for heart failure
time frame: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months
description: Composite endpoint of all cause mortality or hospitalization for heart failure which ever occur first
measure: All cause mortality
time frame: From date of randomization until the date of first documented death from any cause assessed up to 280 events have been adjudicated or up to 36 months
description: All cause mortality
measure: Percentage of patients hospitalized for heart failure
time frame: From date of randomization until the date of first documented hospitalization for heart failure assessed up to 280 events have been adjudicated or up to 36 months
description: Any hospitalization for heart failure occurring after the index STEMI
measure: Percentage of patients with myocardial infarction
time frame: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months
description: Any myocardial infarction occurring after the index STEMI
measure: Cardiovascular death
time frame: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months
description: Cardiovascular death
measure: Percentage of patients with stroke
time frame: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months
description: An acute episode of focal or global neurological dysfunction caused by brain injury
measure: Percentage of patients with a combination of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia
time frame: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months
description: Composite endpoint of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia
measure: Percentage of patients with a combination of hospitalization for heart failure and cardiovascular death
time frame: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months
description: A composite of hospitalization for heart failure and cardiovascular death
measure: Danish eq5d5l standard Quality of life
time frame: 1 year
description: Self assesed quality of life after the Danish eq5d5l standard scale (1 worst score -100 best score)
arm group label: Ischemic postconditioning
arm group type: Active Comparator
description: In addition to state of the art primary PCI in patients with TIMI0-1 ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed, however thrombectomy will not be allowed
arm group label: Conventional
arm group type: Placebo Comparator
description: State of the art primary PCI in patients with TIMI0-1 will be performed, however thrombectomy will not be allowed
intervention type: Procedure
intervention name: Ischemic postconditioning
description: After 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed
arm group label: Ischemic postconditioning
intervention type: Procedure
intervention name: Conventional
description: State of the art primary PCI, however thrombectomy is not allowed
arm group label: Conventional
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Engstrøm, DMSci
role: Study Chair
affiliation: Rigshospitalet, Denmark
last name: Thomas Engstrøm, DMSci
phone: +4535458444
email: thomas.engstroem@regionh.dk
last name: Jacob Lønborg, DMSci
phone: +4535458176
email: jacob.thomsen.loenborg01@regionh.dk
facility: 
status: Recruiting
contact: 
country: Denmark
citation: Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Clemmensen P, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Ravkilde J, Tilsted HH, Villadsen A, Aaroe J, Jensen SE, Raungaard B, Botker HE, Terkelsen CJ, Maeng M, Kaltoft A, Krusell LR, Jensen LO, Veien KT, Kofoed KF, Torp-Pedersen C, Kyhl K, Nepper-Christensen L, Treiman M, Vejlstrup N, Ahtarovski K, Lonborg J, Kober L; Third Danish Study of Optimal Acute Treatment of Patients With ST Elevation Myocardial Infarction-Ischemic Postconditioning (DANAMI-3-iPOST) Investigators. Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):490-497. doi: 10.1001/jamacardio.2017.0022.
PMID: 28249094
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Thomas Engstrom
investigator title: Professor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: Undecided