<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/NCT03785509</url>
  </required_header>
  <id_info>
    <org_study_id>SMC 2017-04-014-001</org_study_id>
    <nct_id>NCT03785509</nct_id>
  </id_info>
  <brief_title>The Compliance of DAPT and Statins on Clinical Outcomes in Percutaneous Coronary Intervention Patients</brief_title>
  <acronym>CPPCI</acronym>
  <official_title>The Effect of Persistence and Compliance of Antiplatelet and Dyslipidemia Agents on Cardiovascular Outcomes in Real World Patients Undergoing Percutaneous Coronary Intervention</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>
    <has_dmc>No</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>
      A nationwide retrospective cohort study. To investigate the real world medication compliance&#xD;
      and the relation with clinical outcomes.&#xD;
&#xD;
      The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents&#xD;
      are important for the patients undergoing percutaneous coronary intervention. But, the&#xD;
      discontinuation and compliance rate are unknown in the real world setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A nationwide retrospective cohort study. The persistence and compliance to dual anti-platelet&#xD;
      therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous&#xD;
      coronary intervention. The discontinuation and uncompliance may increase a risk. But, the&#xD;
      discontinuation and compliance rate are not well known in the real world patients undergoing&#xD;
      bare metal stents(BMS) and drug eluting stents(DES) insertion.&#xD;
&#xD;
      To investigate the real world medication compliance and the relation with clinical outcomes,&#xD;
      administrative claim data was extracted from the Korean National Healthcare Insurance(KNHI)&#xD;
      database.&#xD;
&#xD;
      All Korean patient date undergoing PCI from January 1, 2011 to December 2011 is extracted. 5&#xD;
      year clinical outcomes are investigated.&#xD;
&#xD;
      Primary outcomes are the MACE including all-cause death, revascularization, critically ill&#xD;
      status, and stroke) classified by the medication compliance. Medication complinace is&#xD;
      measured by proportion of days covered(PDC)&#xD;
&#xD;
      Secondary outcomes are the patterns of medication persistence and its outcomes to understand&#xD;
      critical points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 6, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">February 6, 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</measure>
    <time_frame>5 years</time_frame>
    <description>5 year incidence densities of a major adverse clinical events(MACEs) consisting of all-cause death, revascularization, critically ill status and stroke.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance defined as a proportion of days covered (%)</measure>
    <time_frame>6 month</time_frame>
    <description>PDC (Proportion of days covered)</description>
  </secondary_outcome>
  <enrollment type="Actual">47291</enrollment>
  <condition>Platelet Aggregation Inhibitors</condition>
  <condition>Hydroxymethylglutaryl-coa Reductase Inhibitors</condition>
  <condition>Compliance, Medication</condition>
  <condition>Adherence, Medication</condition>
  <condition>Persistence, Medication</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAPT, Statin</intervention_name>
    <description>Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent</description>
    <other_name>DES, BMS</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing PCI using stents in 2011 from all medical providers in Korea is&#xD;
        selected using National Health Insurance Services.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. All claim of percutaneous coronary intervention using stent in the National Healthcare&#xD;
        Insurance Service of Korea between January 1st 2011 and December 31st, 2011&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No use of stents&#xD;
&#xD;
          2. Stent not classified into DES or BMS&#xD;
&#xD;
          3. Use of DES and BMS together at the same initial day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </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 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 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</investigator_title>
  </responsible_party>
  <keyword>DAPT, Statin, Compliance, Persistence, Adherence, PCI</keyword>
  <!-- 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/NCT03785509
org study id: SMC 2017-04-014-001
nct id: NCT03785509
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A nationwide retrospective cohort study. To investigate the real world medication compliance
      and the relation with clinical outcomes.

      The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents
      are important for the patients undergoing percutaneous coronary intervention. But, the
      discontinuation and compliance rate are unknown in the real world setting.
A nationwide retrospective cohort study. The persistence and compliance to dual anti-platelet
      therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous
      coronary intervention. The discontinuation and uncompliance may increase a risk. But, the
      discontinuation and compliance rate are not well known in the real world patients undergoing
      bare metal stents(BMS) and drug eluting stents(DES) insertion.

      To investigate the real world medication compliance and the relation with clinical outcomes,
      administrative claim data was extracted from the Korean National Healthcare Insurance(KNHI)
      database.

      All Korean patient date undergoing PCI from January 1, 2011 to December 2011 is extracted. 5
      year clinical outcomes are investigated.

      Primary outcomes are the MACE including all-cause death, revascularization, critically ill
      status, and stroke) classified by the medication compliance. Medication complinace is
      measured by proportion of days covered(PDC)

      Secondary outcomes are the patterns of medication persistence and its outcomes to understand
      critical points.
observational model: Cohort
time perspective: Retrospective
measure: Incidence density of MACE
time frame: 5 years
description: 5 year incidence densities of a major adverse clinical events(MACEs) consisting of all-cause death, revascularization, critically ill status and stroke.
measure: Compliance defined as a proportion of days covered (%)
time frame: 6 month
description: PDC (Proportion of days covered)
intervention type: Drug
intervention name: DAPT, Statin
description: Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent
other name: DES, BMS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
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