<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/NCT01717573</url>
  </required_header>
  <id_info>
    <org_study_id>Defer-PG-11-2-28474</org_study_id>
    <nct_id>NCT01717573</nct_id>
    <nct_alias>NCT01851291</nct_alias>
  </id_info>
  <brief_title>Deferred Stent Trial in STEMI</brief_title>
  <official_title>Randomised Controlled Study to Assess Whether Deferred Stenting in Acute STEMI Patients Might Reduce the Incidence of No-reflow Versus Conventional Treatment With Immediate Stenting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS National Waiting Times Centre Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>British Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Sciences Scotland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chief Scientist Office, Scottish Government</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS National Waiting Times Centre Board</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During primary PCI, stent deployment and post-dilatation are associated with no-reflow. The&#xD;
      mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus formation&#xD;
      and vascular spasm. No reflow is associated with risk factors such as prolonged duration of&#xD;
      ischaemia, heavy thrombus burden, persistent ST elevation and long stent length. ACTIVE&#xD;
      HYPOTHESIS: once normal antegrade flow has been re-established with initial aspiration&#xD;
      thrombectomy and/or balloon angioplasty at the beginning of primary PCI, compared with usual&#xD;
      care with direct stenting, a strategy of deferred stenting for 4 -16 hours to permit the&#xD;
      beneficial effects of normalized coronary blood flow and anti-thrombotic therapies will&#xD;
      reduce the incidence of no reflow in at-risk STEMI patients. DESIGN: In consecutive STEMI&#xD;
      patients with risk factors for no reflow and who have given informed consent, when normal&#xD;
      flow has been established (TIMI 3) by initial aspiration thrombectomy and/or balloon&#xD;
      angioplasty, participants will be randomized to deferred stenting or usual care with direct&#xD;
      stenting. All patients will receive dual anti-platelet therapy. Patients who are randomized&#xD;
      to deferred stenting will receive intravenous glycoprotein IIbIIIa inhibitor and&#xD;
      anti-coagulation with low molecular weight heparin. Patients who are screened and not&#xD;
      eligible to be randomized will be prospectively entered into a registry. Study assessments&#xD;
      for feasibility, safety and efficacy will be prospectively performed. An independent clinical&#xD;
      event committee will review all serious adverse events. Study endpoints will be subject to&#xD;
      core laboratory analyses. The study is intended to inform the design of a larger multicentre&#xD;
      clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Incidence of angiographic no-reflow/ slow-reflow (TIMI flow grade &lt; 3) in the deferred and conventional treatment groups</measure>
    <time_frame>Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Extent of late microvascular obstruction (MVO) assessed by cardiac MRI</measure>
    <time_frame>MRI 2-5 days post randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical events (hospitalisation for heart failure, re-infarction, cardiac death)</measure>
    <time_frame>Assessed at index admission and 6-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of ST-segment resolution on ECG</measure>
    <time_frame>ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIMI coronary arter flow grade</measure>
    <time_frame>At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Culprit vessel dimensions (QCA) and thrombus burden</measure>
    <time_frame>Initial coronary angiogram (and 2nd angiogram in deferred group)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LV ejection fraction</measure>
    <time_frame>Cardiac MRI 2 days and 6-months post PCI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Index of microvascular resistance (IMR)</measure>
    <time_frame>Assessed following stent deployment (initial procedure for the conventional group and 2nd procedure for the deferred group)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected TIMI frame count</measure>
    <time_frame>At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic tissue myocardial blush grade</measure>
    <time_frame>Angiographic myocardial blush grade at the end of the first procedure (both groups) and at the end of the second procedure in the deferred group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-procedural thrombotic events</measure>
    <time_frame>Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of adverse remodelling (end-systolic and end-diastolic volume index)</measure>
    <time_frame>Cardiac MRI at 6-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final infarct size and myocardial salvage</measure>
    <time_frame>Assessed from cardiac MRI day 2-5 and cardiac MRI at 6months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Bleeding</measure>
    <time_frame>Index hospital admission</time_frame>
    <description>Bleeding events related to vascular access or non-access site bleeding. Bleeding was defined according to the ACUITY criteria: major bleed = intracranial or intraocular bleeding; bleeding at the site of angiography requiring intervention; a hematoma of 5 cm in diameter; a reduction in hemoglobin level of at least 4 g/dL in the absence of overt bleeding or 3 g/dL with a source of bleeding; or transfusion.</description>
  </other_outcome>
  <other_outcome>
    <measure>Contrast nephropathy</measure>
    <time_frame>Index hospitalization</time_frame>
    <description>Contrast-induced nephropathy was defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0•5 mg/dL after a radiographic examination using a contrast agent.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>ST-Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Deferred stenting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During primary PCI in STEMI, when TIMI 3 flow has been re-established with guide-wire, aspiration thrombectomy and/or balloon angioplasty, stenting is then deferred for a period of 4-16 hours following reperfusion. During this time, patients remain in the Coronary Care Unit and will receive intravenous tirofiban and subcutaneous low molecular weight heparin (enoxaparin 1 mg/kg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Conventional treatment in STEMI, with immediate stenting</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deferred stenting</intervention_name>
    <arm_group_label>Deferred stenting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional treatment</intervention_name>
    <arm_group_label>Conventional treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rescue PCI&#xD;
&#xD;
          -  Prolonged ischaemic time (&gt; 12hours)&#xD;
&#xD;
          -  Previous MI&#xD;
&#xD;
          -  Age &gt; 65&#xD;
&#xD;
          -  Occluded artery (TIMI 0/1) at initial angiography&#xD;
&#xD;
          -  Thrombus burden (TIMI grade 2+)&#xD;
&#xD;
          -  Long plaque/ stent length (&gt; 24 mm)&#xD;
&#xD;
          -  Severe coronary artery disease (e.g calcified artery)&#xD;
&#xD;
          -  Small reference vessel diameter (&lt; 2.5 mm)&#xD;
&#xD;
          -  Persistent ST-elevation (&gt; 50%) following reperfusion&#xD;
&#xD;
          -  Index of microvascular resistance (IMR) &gt; 40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of normal coronary flow (TIMI 3)&#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>Colin Berry, BSc PhD FRCP FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Golden Jubilee National Hospital; University of Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Golden Jubilee National Hospital</name>
      <address>
        <city>Clydebank</city>
        <state>Glasgow</state>
        <zip>G81 4DY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.bhf.org.uk/research</url>
    <description>British Heart Foundation</description>
  </link>
  <link>
    <url>http://www.gla.ac.uk/researchinstitutes/icams/</url>
    <description>Institute of Cardiovascular and Medical Sciences, University of Glasgow</description>
  </link>
  <results_reference>
    <citation>Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie MC, Eteiba H, Hood S, Owens C, Watkins S, Layland J, Lindsay M, Peat E, Rae A, Behan M, Sood A, Hillis WS, Mordi I, Mahrous A, Ahmed N, Wilson R, Lasalle L, Genereux P, Ford I, Berry C. A randomized trial of deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI). J Am Coll Cardiol. 2014 May 27;63(20):2088-2098. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27.</citation>
    <PMID>24583294</PMID>
  </results_reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>June 10, 2017</last_update_submitted>
  <last_update_submitted_qc>June 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>NHS National Waiting Times Centre Board</investigator_affiliation>
    <investigator_full_name>Colin Berry</investigator_full_name>
    <investigator_title>Consultant Cardiologist</investigator_title>
  </responsible_party>
  <keyword>STEMI</keyword>
  <keyword>No-reflow</keyword>
  <keyword>Primary percutaneous intervention</keyword>
  <keyword>Deferred stenting</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>


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/NCT01717573
org study id: Defer-PG-11-2-28474
nct id: NCT01717573
nct alias: NCT01851291
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
During primary PCI, stent deployment and post-dilatation are associated with no-reflow. The
      mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus formation
      and vascular spasm. No reflow is associated with risk factors such as prolonged duration of
      ischaemia, heavy thrombus burden, persistent ST elevation and long stent length. ACTIVE
      HYPOTHESIS: once normal antegrade flow has been re-established with initial aspiration
      thrombectomy and/or balloon angioplasty at the beginning of primary PCI, compared with usual
      care with direct stenting, a strategy of deferred stenting for 4 -16 hours to permit the
      beneficial effects of normalized coronary blood flow and anti-thrombotic therapies will
      reduce the incidence of no reflow in at-risk STEMI patients. DESIGN: In consecutive STEMI
      patients with risk factors for no reflow and who have given informed consent, when normal
      flow has been established (TIMI 3) by initial aspiration thrombectomy and/or balloon
      angioplasty, participants will be randomized to deferred stenting or usual care with direct
      stenting. All patients will receive dual anti-platelet therapy. Patients who are randomized
      to deferred stenting will receive intravenous glycoprotein IIbIIIa inhibitor and
      anti-coagulation with low molecular weight heparin. Patients who are screened and not
      eligible to be randomized will be prospectively entered into a registry. Study assessments
      for feasibility, safety and efficacy will be prospectively performed. An independent clinical
      event committee will review all serious adverse events. Study endpoints will be subject to
      core laboratory analyses. The study is intended to inform the design of a larger multicentre
      clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Incidence of angiographic no-reflow/ slow-reflow (TIMI flow grade < 3) in the deferred and conventional treatment groups
time frame: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)
measure: Extent of late microvascular obstruction (MVO) assessed by cardiac MRI
time frame: MRI 2-5 days post randomisation
measure: Clinical events (hospitalisation for heart failure, re-infarction, cardiac death)
time frame: Assessed at index admission and 6-months
measure: Degree of ST-segment resolution on ECG
time frame: ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion
measure: TIMI coronary arter flow grade
time frame: At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group
measure: Culprit vessel dimensions (QCA) and thrombus burden
time frame: Initial coronary angiogram (and 2nd angiogram in deferred group)
measure: Change in LV ejection fraction
time frame: Cardiac MRI 2 days and 6-months post PCI
measure: Index of microvascular resistance (IMR)
time frame: Assessed following stent deployment (initial procedure for the conventional group and 2nd procedure for the deferred group)
measure: Corrected TIMI frame count
time frame: At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group
measure: Angiographic tissue myocardial blush grade
time frame: Angiographic myocardial blush grade at the end of the first procedure (both groups) and at the end of the second procedure in the deferred group
measure: Intra-procedural thrombotic events
time frame: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)
measure: Degree of adverse remodelling (end-systolic and end-diastolic volume index)
time frame: Cardiac MRI at 6-months
measure: Final infarct size and myocardial salvage
time frame: Assessed from cardiac MRI day 2-5 and cardiac MRI at 6months
measure: Bleeding
time frame: Index hospital admission
description: Bleeding events related to vascular access or non-access site bleeding. Bleeding was defined according to the ACUITY criteria: major bleed = intracranial or intraocular bleeding; bleeding at the site of angiography requiring intervention; a hematoma of 5 cm in diameter; a reduction in hemoglobin level of at least 4 g/dL in the absence of overt bleeding or 3 g/dL with a source of bleeding; or transfusion.
measure: Contrast nephropathy
time frame: Index hospitalization
description: Contrast-induced nephropathy was defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0•5 mg/dL after a radiographic examination using a contrast agent.
arm group label: Deferred stenting
arm group type: Active Comparator
description: During primary PCI in STEMI, when TIMI 3 flow has been re-established with guide-wire, aspiration thrombectomy and/or balloon angioplasty, stenting is then deferred for a period of 4-16 hours following reperfusion. During this time, patients remain in the Coronary Care Unit and will receive intravenous tirofiban and subcutaneous low molecular weight heparin (enoxaparin 1 mg/kg)
arm group label: Conventional treatment
arm group type: Sham Comparator
description: Conventional treatment in STEMI, with immediate stenting
intervention type: Procedure
intervention name: Deferred stenting
arm group label: Deferred stenting
intervention type: Procedure
intervention name: Conventional treatment
arm group label: Conventional treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Colin Berry, BSc PhD FRCP FACC
role: Principal Investigator
affiliation: Golden Jubilee National Hospital; University of Glasgow
facility: 
country: United Kingdom
url: https://www.bhf.org.uk/research
description: British Heart Foundation
url: http://www.gla.ac.uk/researchinstitutes/icams/
description: Institute of Cardiovascular and Medical Sciences, University of Glasgow
citation: Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie MC, Eteiba H, Hood S, Owens C, Watkins S, Layland J, Lindsay M, Peat E, Rae A, Behan M, Sood A, Hillis WS, Mordi I, Mahrous A, Ahmed N, Wilson R, Lasalle L, Genereux P, Ford I, Berry C. A randomized trial of deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI). J Am Coll Cardiol. 2014 May 27;63(20):2088-2098. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27.
PMID: 24583294
responsible party type: Principal Investigator
investigator affiliation: NHS National Waiting Times Centre Board
investigator full name: Colin Berry
investigator title: Consultant Cardiologist
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction