<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/NCT03788148</url>
  </required_header>
  <id_info>
    <org_study_id>SMC 2017-11-132</org_study_id>
    <nct_id>NCT03788148</nct_id>
  </id_info>
  <brief_title>Bare Metal Stents and Drug Eluting Stents in Patients Who Underwent Blood Transfusion</brief_title>
  <acronym>TFPCI2</acronym>
  <official_title>Bare-metal Stents(BMS) Versus Drug-eluting Stents(DES) in Patients Who Underwent Periprocedural Blood Transfusion : A Nationwide Longitudinal Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retrospective cohort study of Korean National Healthcare Insurance Database. To investigate&#xD;
      clinical outcomes of bare metal stents versus drug eluting stents in patients who underwent&#xD;
      periprocedural red blood cell transfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Korean nationwide, multi-center, retrospective observational cohort study.&#xD;
&#xD;
      The receipt of red blood cell transfusion is at high risk of cardiac events or death. But&#xD;
      little is know regarding the comparative outcomes of BMS and DES implantation in patients who&#xD;
      underwent periprocedural red blood cell transfusion.&#xD;
&#xD;
      Longitudinal data is collected from administrative claims in the national health insurance&#xD;
      services of Korea. All Korean data(N=500,591) undergoing PCI from 2006 to 2015 is extracted.&#xD;
      BMS or DES Patients(N=28,322) who received periprocedural red blood cell transfusion is&#xD;
      investigate. Clinical outcomes until December 31, 2017 is investigate.&#xD;
&#xD;
      Primary endpoint is a time to the first major adverse clinical event(MACE) defined as a&#xD;
      composite of all-cause death, revascularization, critically ill cardiovascular status, or&#xD;
      stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>Incidence density of MACE (Major adverse clinical events)</measure>
    <time_frame>3 years</time_frame>
    <description>The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence density of MACE (Major adverse clinical events)</measure>
    <time_frame>1 year</time_frame>
    <description>The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.</description>
  </primary_outcome>
  <enrollment type="Actual">28322</enrollment>
  <condition>Erythrocyte Transfusion</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <condition>Revascularization</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stent, red blood cell transfusion</intervention_name>
    <description>BMS (Bare Metal Stent) and DES (drug-eluting stent) transplants with periprocedural red blood cell transfusion</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All Korean patients undergoing BMS or DES implantation from January 1, 2005 to December 31,&#xD;
        2016 who received periprocedural red blood cell transfusion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with percutaneous coronary intervention from 2006 to 2015&#xD;
&#xD;
          -  Patients with the implantation of BMS or DES&#xD;
&#xD;
          -  Patients with the receipt of periprocedural red blood cell transfusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without any of stent implantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Ho Choi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gang nam-Gu, Ilwon-Dong</state>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jin-Ho Choi</investigator_full_name>
    <investigator_title>MD, PhD, Professor, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>transfusion, PCI, DES, BMS</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03788148
org study id: SMC 2017-11-132
nct id: NCT03788148
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Retrospective cohort study of Korean National Healthcare Insurance Database. To investigate
      clinical outcomes of bare metal stents versus drug eluting stents in patients who underwent
      periprocedural red blood cell transfusion.
A Korean nationwide, multi-center, retrospective observational cohort study.

      The receipt of red blood cell transfusion is at high risk of cardiac events or death. But
      little is know regarding the comparative outcomes of BMS and DES implantation in patients who
      underwent periprocedural red blood cell transfusion.

      Longitudinal data is collected from administrative claims in the national health insurance
      services of Korea. All Korean data(N=500,591) undergoing PCI from 2006 to 2015 is extracted.
      BMS or DES Patients(N=28,322) who received periprocedural red blood cell transfusion is
      investigate. Clinical outcomes until December 31, 2017 is investigate.

      Primary endpoint is a time to the first major adverse clinical event(MACE) defined as a
      composite of all-cause death, revascularization, critically ill cardiovascular status, or
      stroke.
observational model: Cohort
time perspective: Retrospective
measure: Incidence density of MACE (Major adverse clinical events)
time frame: 3 years
description: The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.
measure: Incidence density of MACE (Major adverse clinical events)
time frame: 1 year
description: The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.
intervention type: Device
intervention name: Stent, red blood cell transfusion
description: BMS (Bare Metal Stent) and DES (drug-eluting stent) transplants with periprocedural red blood cell transfusion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jin-Ho Choi, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jin-Ho Choi
investigator title: MD, PhD, Professor, Principal Investigator
sharing ipd: No