<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/NCT02264912</url>
  </required_header>
  <id_info>
    <org_study_id>05-2008</org_study_id>
    <nct_id>NCT02264912</nct_id>
  </id_info>
  <brief_title>The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry</brief_title>
  <acronym>LAPCOR</acronym>
  <official_title>The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculty Hospital Kralovske Vinohrady</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculty Hospital Kralovske Vinohrady</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry&#xD;
      was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who&#xD;
      underwent intracoronary stent implantation, have been included regardless of whether&#xD;
      percutaneous coronary intervention (PCI) was performed on urgent or elective basis.Patients&#xD;
      were included in the registry after having signed an informed consent for participation. No&#xD;
      exclusion criterion has been applied for the registry participation. Efficacy of P2Y12&#xD;
      receptor antagonists has been measured by quantitative flow cytometric analysis of&#xD;
      vasodilator-stimulated phosphoprotein (VASP) phosphorylation according to the manufacturer&#xD;
      protocol (Platelet VASP; Diagnostica Stago, Biocytex, Asnières, France) on a FACScan flow&#xD;
      cytometer (Becton Dickinson). Occurrence of major adverse cardiac events at 30 days, 6-months&#xD;
      and one year follow up has been investigated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2008</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>laboratory efficacy of antiplatelet drugs measured as residual platelet reactivity, incidence of major adverse cardiovascular events and bleeding complications</measure>
    <time_frame>During the 12 months after implantation of an intracoronary stent</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2016</enrollment>
  <condition>Platelet Aggregation Onhibitors</condition>
  <arm_group>
    <arm_group_label>stent-PCI patients</arm_group_label>
    <description>Consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>antiplatelet drugs - P2Y12 antagonists</intervention_name>
    <arm_group_label>stent-PCI patients</arm_group_label>
    <other_name>clopidogrel, prasugrel, ticagrelor</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients were included in the registry after having signed an informed consent for&#xD;
        participation. No exclusion criterion has been applied for the registry participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients after stent PCI treated with P2Y12 antagonist&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#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>Zuzana Motovska, MD.PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty Hospital Kralovske Vinohrady</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty Hospital Kralovske Vinohrady</name>
      <address>
        <city>Prague</city>
        <zip>10034</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <results_reference>
    <citation>Motovska Z, Odvodyova D, Fischerova M, Stepankova S, Maly M, Morawska P, Widimsky P. Renal function assessed using cystatin C and antiplatelet efficacy of clopidogrel assessed using the vasodilator-stimulated phosphoprotein index in patients having percutaneous coronary intervention. Am J Cardiol. 2012 Mar 1;109(5):620-3. doi: 10.1016/j.amjcard.2011.10.019. Epub 2011 Dec 10.</citation>
    <PMID>22154314</PMID>
  </results_reference>
  <results_reference>
    <citation>Motovska Z, Ondrakova M, Doktorova M, Widimsky P. Severe left ventricular systolic dysfunction is independently associated with high on-clopidogrel platelet reactivity. Am J Cardiovasc Drugs. 2014 Aug;14(4):313-8. doi: 10.1007/s40256-014-0074-3.</citation>
    <PMID>24728851</PMID>
  </results_reference>
  <results_reference>
    <citation>Ondrakova M, Knot J, Ulman J, Maly M, Motovska Z. Efficacy of P2Y12 receptor antagonists in patients with atrial fibrillation according to the CHA2DS2VASc score. Int J Cardiol. 2016 Mar 15;207:84-6. doi: 10.1016/j.ijcard.2016.01.039. Epub 2016 Jan 6. No abstract available.</citation>
    <PMID>26797336</PMID>
  </results_reference>
  <results_reference>
    <citation>Motovska Z, Ondrakova M, Bednar F, Knot J, Ulman J, Maly M. Selection of P2Y12 antagonist, treatment initiation, and predictors of high on-treatment platelet reactivity in a &quot;Real World&quot; registry. Thromb Res. 2015 Jun;135(6):1093-9. doi: 10.1016/j.thromres.2015.04.014. Epub 2015 Apr 16.</citation>
    <PMID>25917561</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculty Hospital Kralovske Vinohrady</investigator_affiliation>
    <investigator_full_name>Zuzana Motovska</investigator_full_name>
    <investigator_title>Associate Professor, MD. PhD. FESC.</investigator_title>
  </responsible_party>
  <keyword>antiplatelets, percutanous coronary intervention, acute coronary syndromes, laboratory efficacy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
    <mesh_term>Ticagrelor</mesh_term>
    <mesh_term>Prasugrel Hydrochloride</mesh_term>
    <mesh_term>Platelet Aggregation Inhibitors</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/NCT02264912
org study id: 05-2008
nct id: NCT02264912
lead sponsor: 
has dmc: No
The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry
      was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who
      underwent intracoronary stent implantation, have been included regardless of whether
      percutaneous coronary intervention (PCI) was performed on urgent or elective basis.Patients
      were included in the registry after having signed an informed consent for participation. No
      exclusion criterion has been applied for the registry participation. Efficacy of P2Y12
      receptor antagonists has been measured by quantitative flow cytometric analysis of
      vasodilator-stimulated phosphoprotein (VASP) phosphorylation according to the manufacturer
      protocol (Platelet VASP; Diagnostica Stago, Biocytex, Asnières, France) on a FACScan flow
      cytometer (Becton Dickinson). Occurrence of major adverse cardiac events at 30 days, 6-months
      and one year follow up has been investigated.
observational model: Cohort
time perspective: Prospective
measure: laboratory efficacy of antiplatelet drugs measured as residual platelet reactivity, incidence of major adverse cardiovascular events and bleeding complications
time frame: During the 12 months after implantation of an intracoronary stent
arm group label: stent-PCI patients
description: Consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis.
intervention type: Drug
intervention name: antiplatelet drugs - P2Y12 antagonists
arm group label: stent-PCI patients
other name: clopidogrel, prasugrel, ticagrelor
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zuzana Motovska, MD.PhD.
role: Principal Investigator
affiliation: Faculty Hospital Kralovske Vinohrady
facility: 
country: Czechia
country: Czech Republic
citation: Motovska Z, Odvodyova D, Fischerova M, Stepankova S, Maly M, Morawska P, Widimsky P. Renal function assessed using cystatin C and antiplatelet efficacy of clopidogrel assessed using the vasodilator-stimulated phosphoprotein index in patients having percutaneous coronary intervention. Am J Cardiol. 2012 Mar 1;109(5):620-3. doi: 10.1016/j.amjcard.2011.10.019. Epub 2011 Dec 10.
PMID: 22154314
citation: Motovska Z, Ondrakova M, Doktorova M, Widimsky P. Severe left ventricular systolic dysfunction is independently associated with high on-clopidogrel platelet reactivity. Am J Cardiovasc Drugs. 2014 Aug;14(4):313-8. doi: 10.1007/s40256-014-0074-3.
PMID: 24728851
citation: Ondrakova M, Knot J, Ulman J, Maly M, Motovska Z. Efficacy of P2Y12 receptor antagonists in patients with atrial fibrillation according to the CHA2DS2VASc score. Int J Cardiol. 2016 Mar 15;207:84-6. doi: 10.1016/j.ijcard.2016.01.039. Epub 2016 Jan 6. No abstract available.
PMID: 26797336
citation: Motovska Z, Ondrakova M, Bednar F, Knot J, Ulman J, Maly M. Selection of P2Y12 antagonist, treatment initiation, and predictors of high on-treatment platelet reactivity in a "Real World" registry. Thromb Res. 2015 Jun;135(6):1093-9. doi: 10.1016/j.thromres.2015.04.014. Epub 2015 Apr 16.
PMID: 25917561
responsible party type: Principal Investigator
investigator affiliation: Faculty Hospital Kralovske Vinohrady
investigator full name: Zuzana Motovska
investigator title: Associate Professor, MD. PhD. FESC.
mesh term: Clopidogrel
mesh term: Ticagrelor
mesh term: Prasugrel Hydrochloride
mesh term: Platelet Aggregation Inhibitors