<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/NCT02193971</url>
  </required_header>
  <id_info>
    <org_study_id>HOST REDUCE POLYTECH RCT</org_study_id>
    <nct_id>NCT02193971</nct_id>
  </id_info>
  <brief_title>Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of PrasugrEl Dose &amp; POLYmer TECHnology in ACS Patients (HOST REDUCE POLYTECH RCT Trial)</brief_title>
  <official_title>Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of PrasugrEl Dose &amp; POLYmer TECHnology in ACS Patients (HOST REDUCE POLYTECH RCT Trial) Comparison of the Efficacy and Safety of Biostable Polymer DES (Promus PremierTM, Xience Alpine®, and Resolute Onyx®) With Biodegradable Polymer DES (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®,Synergy®, and Orsiro®)and Conventional Dose Prasugrel Therapy With Reduced Dose Prasugrel Therapy in Acute Coronary Syndrome Patients Treated With Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Korea Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dio</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Terumo Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Study objectives&#xD;
&#xD;
             1. To compare the safety and long-term efficacy of coronary stenting with biostable&#xD;
                polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) with&#xD;
                biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®,&#xD;
                Ultimaster®, Synergy ® and Orsiro®) in patients with acute coronary syndrome&#xD;
&#xD;
             2. To compare the efficacy and safety of 5 mg prasugrel maintenance therapy compared&#xD;
                with 10 mg prasugrel maintenance therapy in patients with acute coronary syndrome&#xD;
                undergoing percutaneous coronary intervention&#xD;
&#xD;
        -  Study design :&#xD;
&#xD;
      Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the&#xD;
      following in CHD patients&#xD;
&#xD;
        1. Non-inferiority of biostable polymer drug-eluting stent (Promus PremierTM, Xience&#xD;
           Alpine®, Resolute Onyx®) compared with biodegradable polymer drug-eluting stent&#xD;
           (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in terms of&#xD;
           patient-oriented composite outcome&#xD;
&#xD;
        2. Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of&#xD;
           major adverse cardiovascular events&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 3400 patients derived from a population of Korean patients with acute coronary syndrome&#xD;
      receiving percutaneous coronary intervention will be enrolled in the present trial.&#xD;
&#xD;
      All patients will receive a loading dose of aspirin (300 mg) and prasugrel (60 mg bolus) will&#xD;
      be administered. Sixty-mg-loading dose of prasugrel will be given regardless of pretreated&#xD;
      antiplatelet agents (clopidogrel, ticagrelor, or cilostazol). However, in patients who&#xD;
      already loaded with other antiplatelet agents (clopidigrel, ticagrelor, or cilostazol),&#xD;
      reduced dose (30mg) or omission of prasugrel loading is acceptable. Following angiography,&#xD;
      patients with significant diameter stenosis &gt;50% of coronary artery or graft vessel by visual&#xD;
      estimation that have documented myocardial ischemia or symptoms of angina, and have lesions&#xD;
      that are eligible for coronary intervention without any exclusion criteria, will be&#xD;
      randomized 1:1 to either receive either BS-DES or BD-DES group.&#xD;
&#xD;
      At 1-month clinical follow-up, patients eligible for antiplatelet comparison will be&#xD;
      additionally randomized 1:1 to either receive the reduce dose of prasugrel (5 mg daily) or&#xD;
      conventional dose (10 mg daily). The exclusion criteria (age ≥75 years, body weight &lt;60 kg,&#xD;
      or history of TIA or stroke) is classified as observational cohort. Post-PCI, dual&#xD;
      antiplatelet therapy is recommended for at least 1 year. Follow-up data will be collected&#xD;
      until 3-year after index procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <phase>Phase 4</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>Stent arm : patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or repeat revascularization</measure>
    <time_frame>12months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Antiplatelet arm : major adverse cardiovascular event (MACE), defined as a composite of all death, MI, stent thrombosis, repeat revascularization, CVA, and BARC class ≥2 bleeding</measure>
    <time_frame>12months</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">3384</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>BS-DES with prasugrel 10mg daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BS-DES with prasugrel 10mg daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BS-DES with prasugrel 5mg daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BS-DES with prasugrel 5mg daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BD-DES with prasugrel 10mg daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BD-DES with prasugrel 10mg daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BD-DES with prasugrel 5mg daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BD-DES with prasugrel 5mg daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BS-DES (Biostable polymer drug-eluting stent)</intervention_name>
    <arm_group_label>BS-DES with prasugrel 10mg daily</arm_group_label>
    <arm_group_label>BS-DES with prasugrel 5mg daily</arm_group_label>
    <other_name>Promus Premier</other_name>
    <other_name>Xience Alpine</other_name>
    <other_name>Resolute Onyx</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BD-DES (Biodegradable polymer drug-eluting stent)</intervention_name>
    <arm_group_label>BD-DES with prasugrel 10mg daily</arm_group_label>
    <arm_group_label>BD-DES with prasugrel 5mg daily</arm_group_label>
    <other_name>Biomatrix</other_name>
    <other_name>Biomatrix Flex</other_name>
    <other_name>Nobori</other_name>
    <other_name>Ultimaster</other_name>
    <other_name>Synergy</other_name>
    <other_name>Orsiro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prasugrel 5mg</intervention_name>
    <description>Use prasugrel 5mg daily for maintaning dose</description>
    <arm_group_label>BD-DES with prasugrel 5mg daily</arm_group_label>
    <arm_group_label>BS-DES with prasugrel 5mg daily</arm_group_label>
    <other_name>Prasugrel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be ≥ 18 years&#xD;
&#xD;
          -  Subject is able to verbally confirm understandings of risks, benefits and treatment&#xD;
             alternatives of receiving PCI and he/she or his/her legally authorized representative&#xD;
             provides written informed consent prior to any study related procedure.&#xD;
&#xD;
          -  Subject must have a culprit lesion in a native coronary artery with significant&#xD;
             stenosis (&gt;50% by visual estimate) eligible for stent implantation&#xD;
&#xD;
          -  Subject must have clinical diagnosis of acute coronary syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Following patients will be enrolled in stent comparison, but excluded from&#xD;
             antiplatelet comparison. They will be classified as observational cohort.&#xD;
&#xD;
          -  Subjects ≥75 years&#xD;
&#xD;
          -  Body weight &lt;60 kg&#xD;
&#xD;
          -  History of TIA or stroke&#xD;
&#xD;
          -  The patient has a known hypersensitivity or contraindication to any of the following&#xD;
             medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Biolimus,&#xD;
             Everolimus, Contrast media (Patients with documented sensitivity to contrast media&#xD;
             which can be effectively premedicated with steroids and diphenhydramine [e.g. rash]&#xD;
             may be enrolled. Those with true anaphylaxis to prior contrast media, however, should&#xD;
             not be enrolled.)&#xD;
&#xD;
          -  Patients with active pathologic bleeding&#xD;
&#xD;
          -  Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery&#xD;
             within 2 months.&#xD;
&#xD;
          -  Systemic (intravenous) Biolimus, or everolimus use within 12 months.&#xD;
&#xD;
          -  Female of childbearing potential, unless a recent pregnancy test is negative, who&#xD;
             possibly plan to become pregnant any time after enrollment into this study.&#xD;
&#xD;
          -  History of bleeding diathesis, known coagulopathy (including heparin-induced&#xD;
             thrombocytopenia), or will refuse blood transfusions&#xD;
&#xD;
          -  Non-cardiac co-morbid conditions are present with life expectancy &lt;1 year or that may&#xD;
             result in protocol non-compliance (per site investigator's medical judgment).&#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>Hyo-Soo Kim, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>January 28, 2020</last_update_submitted>
  <last_update_submitted_qc>January 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute coronary syndrome</keyword>
  <keyword>Drug eluting stent</keyword>
  <keyword>Everolimus</keyword>
  <keyword>Prasugrel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prasugrel Hydrochloride</mesh_term>
  </intervention_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/NCT02193971
org study id: HOST REDUCE POLYTECH RCT
nct id: NCT02193971
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
-  Study objectives

             1. To compare the safety and long-term efficacy of coronary stenting with biostable
                polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) with
                biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®,
                Ultimaster®, Synergy ® and Orsiro®) in patients with acute coronary syndrome

             2. To compare the efficacy and safety of 5 mg prasugrel maintenance therapy compared
                with 10 mg prasugrel maintenance therapy in patients with acute coronary syndrome
                undergoing percutaneous coronary intervention

        -  Study design :

      Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the
      following in CHD patients

        1. Non-inferiority of biostable polymer drug-eluting stent (Promus PremierTM, Xience
           Alpine®, Resolute Onyx®) compared with biodegradable polymer drug-eluting stent
           (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in terms of
           patient-oriented composite outcome

        2. Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of
           major adverse cardiovascular events
About 3400 patients derived from a population of Korean patients with acute coronary syndrome
      receiving percutaneous coronary intervention will be enrolled in the present trial.

      All patients will receive a loading dose of aspirin (300 mg) and prasugrel (60 mg bolus) will
      be administered. Sixty-mg-loading dose of prasugrel will be given regardless of pretreated
      antiplatelet agents (clopidogrel, ticagrelor, or cilostazol). However, in patients who
      already loaded with other antiplatelet agents (clopidigrel, ticagrelor, or cilostazol),
      reduced dose (30mg) or omission of prasugrel loading is acceptable. Following angiography,
      patients with significant diameter stenosis >50% of coronary artery or graft vessel by visual
      estimation that have documented myocardial ischemia or symptoms of angina, and have lesions
      that are eligible for coronary intervention without any exclusion criteria, will be
      randomized 1:1 to either receive either BS-DES or BD-DES group.

      At 1-month clinical follow-up, patients eligible for antiplatelet comparison will be
      additionally randomized 1:1 to either receive the reduce dose of prasugrel (5 mg daily) or
      conventional dose (10 mg daily). The exclusion criteria (age ≥75 years, body weight <60 kg,
      or history of TIA or stroke) is classified as observational cohort. Post-PCI, dual
      antiplatelet therapy is recommended for at least 1 year. Follow-up data will be collected
      until 3-year after index procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stent arm : patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or repeat revascularization
time frame: 12months
measure: Antiplatelet arm : major adverse cardiovascular event (MACE), defined as a composite of all death, MI, stent thrombosis, repeat revascularization, CVA, and BARC class ≥2 bleeding
time frame: 12months
arm group label: BS-DES with prasugrel 10mg daily
arm group type: Active Comparator
description: BS-DES with prasugrel 10mg daily
arm group label: BS-DES with prasugrel 5mg daily
arm group type: Active Comparator
description: BS-DES with prasugrel 5mg daily
arm group label: BD-DES with prasugrel 10mg daily
arm group type: Experimental
description: BD-DES with prasugrel 10mg daily
arm group label: BD-DES with prasugrel 5mg daily
arm group type: Experimental
description: BD-DES with prasugrel 5mg daily
intervention type: Device
intervention name: BS-DES (Biostable polymer drug-eluting stent)
arm group label: BS-DES with prasugrel 10mg daily
arm group label: BS-DES with prasugrel 5mg daily
other name: Promus Premier
other name: Xience Alpine
other name: Resolute Onyx
intervention type: Device
intervention name: BD-DES (Biodegradable polymer drug-eluting stent)
arm group label: BD-DES with prasugrel 10mg daily
arm group label: BD-DES with prasugrel 5mg daily
other name: Biomatrix
other name: Biomatrix Flex
other name: Nobori
other name: Ultimaster
other name: Synergy
other name: Orsiro
intervention type: Drug
intervention name: Prasugrel 5mg
description: Use prasugrel 5mg daily for maintaning dose
arm group label: BD-DES with prasugrel 5mg daily
arm group label: BS-DES with prasugrel 5mg daily
other name: Prasugrel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hyo-Soo Kim, MD, PhD
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Prasugrel Hydrochloride