<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/NCT04492423</url>
  </required_header>
  <id_info>
    <org_study_id>VFN-CSS-16-0003</org_study_id>
    <nct_id>NCT04492423</nct_id>
  </id_info>
  <brief_title>VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study</brief_title>
  <official_title>VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Accriva Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Accriva Diagnostics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the range of expected PRUTest values in patients in&#xD;
      the intended use population receiving dual antiplatelet treatment with aspirin and prasugrel&#xD;
      (Effient®), or ticagrelor (Brilinta®).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The on-drug reference range study will be performed by measuring venous blood samples in&#xD;
      duplicate collected from patients receiving prasugrel (Effient®), or ticagrelor (Brilinta®).&#xD;
      Subjects must be on aspirin at the doses prescribed by their treating physician.&#xD;
&#xD;
      When possible, venous blood samples may be collected in conjunction with routine laboratory&#xD;
      testing, to minimize the number of needle sticks for the subject. Alternatively, samples may&#xD;
      be collected separately to complete the study.&#xD;
&#xD;
      A CBC measurement must be performed for each enrolled subject from a sample collected at the&#xD;
      time of blood draw or within ± one week and tested at a certified laboratory. Samples for&#xD;
      PRUTest collected in conjunction with a CBC must be drawn after the PRUTest sample.&#xD;
&#xD;
      Up to 130 subjects will be enrolled in the study to facilitate collection of the minimum&#xD;
      number of blood samples needed to determine the on-drug reference range of prasugrel&#xD;
      (Effient®), or ticagrelor (Brilinta®).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2016</start_date>
  <completion_date type="Actual">March 22, 2018</completion_date>
  <primary_completion_date type="Actual">August 14, 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>PRUTest</measure>
    <time_frame>Within 24 hours of the loading or last maintance dose</time_frame>
    <description>VerifyNow PRUTest results</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Coronary Disease</condition>
  <condition>Platelet Aggregation</condition>
  <arm_group>
    <arm_group_label>Prasugrel</arm_group_label>
    <description>Patients taking prasugrel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ticagrelor</arm_group_label>
    <description>Patients taking ticagrelor</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>VerifyNow PRUTest</intervention_name>
    <description>VerifyNow PRUTest for platelet aggregation</description>
    <arm_group_label>Prasugrel</arm_group_label>
    <arm_group_label>Ticagrelor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 130 subjects will be enrolled in the study to facilitate collection of the minimum&#xD;
        number of blood samples needed to determine the on-drug reference range of prasugrel&#xD;
        (Effient®), or ticagrelor (Brilinta®).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Males and females 18 years and older&#xD;
&#xD;
               -  Able and willing to provide written informed consent.&#xD;
&#xD;
               -  Current treatment with aspirin (any dose).&#xD;
&#xD;
               -  Have a planned or scheduled percutaneous coronary intervention (PCI) with the&#xD;
                  potential to receive treatment with prasugrel (Effient®), or ticagrelor&#xD;
                  (Brilinta®) following an oral loading dose or on maintenance treatment for a&#xD;
                  minimum of seven days who may have symptomatic cerebrovascular disease (transient&#xD;
                  ischemic attack or following a thrombotic stroke) or cardiovascular disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Unable to provide written informed consent.&#xD;
&#xD;
               -  Currently receiving an investigational antiplatelet agent.&#xD;
&#xD;
               -  GP IIb/IIIa therapy (ReoPro®, Integrilin®, Aggrastat®) within the past 2 weeks.&#xD;
&#xD;
               -  Received any therapy containing dipyridamole (Persantine®, Aggrenox®) within the&#xD;
                  past 2 weeks.&#xD;
&#xD;
               -  Women who may be pregnant or are of child bearing potential&#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>Dominick J Angiolillo, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uunversity of Florida Health Jacksonville</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aggregation</keyword>
  <keyword>platelet</keyword>
  <keyword>P2Y12 inhibitor</keyword>
  <keyword>Aspirin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Publication of Results</ipd_description>
  </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/NCT04492423
org study id: VFN-CSS-16-0003
nct id: NCT04492423
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine the range of expected PRUTest values in patients in
      the intended use population receiving dual antiplatelet treatment with aspirin and prasugrel
      (Effient®), or ticagrelor (Brilinta®).
The on-drug reference range study will be performed by measuring venous blood samples in
      duplicate collected from patients receiving prasugrel (Effient®), or ticagrelor (Brilinta®).
      Subjects must be on aspirin at the doses prescribed by their treating physician.

      When possible, venous blood samples may be collected in conjunction with routine laboratory
      testing, to minimize the number of needle sticks for the subject. Alternatively, samples may
      be collected separately to complete the study.

      A CBC measurement must be performed for each enrolled subject from a sample collected at the
      time of blood draw or within ± one week and tested at a certified laboratory. Samples for
      PRUTest collected in conjunction with a CBC must be drawn after the PRUTest sample.

      Up to 130 subjects will be enrolled in the study to facilitate collection of the minimum
      number of blood samples needed to determine the on-drug reference range of prasugrel
      (Effient®), or ticagrelor (Brilinta®).
observational model: Cohort
time perspective: Prospective
measure: PRUTest
time frame: Within 24 hours of the loading or last maintance dose
description: VerifyNow PRUTest results
arm group label: Prasugrel
description: Patients taking prasugrel
arm group label: Ticagrelor
description: Patients taking ticagrelor
intervention type: Diagnostic Test
intervention name: VerifyNow PRUTest
description: VerifyNow PRUTest for platelet aggregation
arm group label: Prasugrel
arm group label: Ticagrelor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominick J Angiolillo, M.D., Ph.D.
role: Principal Investigator
affiliation: Uunversity of Florida Health Jacksonville
responsible party type: Sponsor
mesh term: Coronary Disease
sharing ipd: No
ipd description: Publication of Results