<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/NCT03017625</url>
  </required_header>
  <id_info>
    <org_study_id>2016-2847</org_study_id>
    <nct_id>NCT03017625</nct_id>
  </id_info>
  <brief_title>Platelet Activation and Reactivity in Acute Exacerbations of COPD</brief_title>
  <official_title>Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is known for development of severe&#xD;
      cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD&#xD;
      (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets&#xD;
      contribute to acute cardiovascular events and atherosclerosis. When platelets are activated,&#xD;
      they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early&#xD;
      process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD&#xD;
      is scarcely studied. This study aims to address this gap by investigating platelet function&#xD;
      and coagulation in patients with AE-COPD and after convalescence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.</measure>
    <time_frame>Measured at presentation with an AE-COPD and after 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Platelet-monocyte interaction (CD14 cells positive for CD61)</measure>
    <time_frame>Measured at presentation with an AE-COPD and after 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocyte activation (CD11b expression on CD14 positive cells)</measure>
    <time_frame>Measured at presentation with an AE-COPD and after 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue factor triggered thrombin generation capacity</measure>
    <time_frame>Measured at presentation with an AE-COPD and after 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer</measure>
    <time_frame>Measured at presentation with an AE-COPD and after 8 weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>COPD Exacerbation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood is drawn</intervention_name>
    <description>Blood analyses</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an acute exacerbation of COPD as defined by the Anthonisen criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;40 years&#xD;
&#xD;
          -  Spirometry confirmed diagnosis of COPD (i.e. post-bronchodilator FEV1/FVC &lt; 70% and&#xD;
             less than 12% on reversibility testing&lt; Lower limit of normal (LLN))&#xD;
&#xD;
          -  ≥10 pack years of smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of anti-coagulation or other platelet function inhibitors&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Chronic inflammatory diseases, for example rheumatoid arthritis, psoriasis,&#xD;
             inflammatory bowel diseases , systemic lupus erythematous (SLE)&#xD;
&#xD;
          -  Malignancies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yvonne F Heijdra, Md, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Floor E Aleva, MD</last_name>
    <phone>0031 24 361 03 25</phone>
    <email>floor.aleva@radboudumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yvonne F Heijdra, MD, PhD</last_name>
    <phone>0031 24 361 03 25</phone>
    <email>yvonne.heijdra@radboudumc.nl</email>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Platelets</keyword>
  <keyword>Inflammation</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/NCT03017625
org study id: 2016-2847
nct id: NCT03017625
lead sponsor: 
has dmc: Yes
Chronic obstructive pulmonary disease (COPD) is known for development of severe
      cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD
      (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets
      contribute to acute cardiovascular events and atherosclerosis. When platelets are activated,
      they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early
      process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD
      is scarcely studied. This study aims to address this gap by investigating platelet function
      and coagulation in patients with AE-COPD and after convalescence.
observational model: Cohort
time perspective: Prospective
measure: Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.
time frame: Measured at presentation with an AE-COPD and after 8 weeks
measure: Platelet-monocyte interaction (CD14 cells positive for CD61)
time frame: Measured at presentation with an AE-COPD and after 8 weeks
measure: Monocyte activation (CD11b expression on CD14 positive cells)
time frame: Measured at presentation with an AE-COPD and after 8 weeks
measure: Tissue factor triggered thrombin generation capacity
time frame: Measured at presentation with an AE-COPD and after 8 weeks
measure: Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer
time frame: Measured at presentation with an AE-COPD and after 8 weeks
intervention type: Other
intervention name: Blood is drawn
description: Blood analyses
Blood, plasma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 99 Years
healthy volunteers: No
last name: Yvonne F Heijdra, Md, PhD
role: Principal Investigator
affiliation: Radboud University Medical Center
last name: Floor E Aleva, MD
phone: 0031 24 361 03 25
email: floor.aleva@radboudumc.nl
last name: Yvonne F Heijdra, MD, PhD
phone: 0031 24 361 03 25
email: yvonne.heijdra@radboudumc.nl
responsible party type: Sponsor