<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/NCT01690884</url>
  </required_header>
  <id_info>
    <org_study_id>120477</org_study_id>
    <nct_id>NCT01690884</nct_id>
  </id_info>
  <brief_title>Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake</brief_title>
  <official_title>Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are trying to determine if a single dose of Ticagrelor will increase&#xD;
      delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with&#xD;
      adenosine reuptake blockade.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will compare adenosine interstitial levels using a parallel design study&#xD;
      with three groups of subjects. Forearm interstitial adenosine levels will be measured at&#xD;
      baseline and after intrabrachial infusion of adenosine at two doses. Subjects will then&#xD;
      randomly receive Ticagrelor 180 mg, Dipyridamole 200 mg, or placebo. Two hours later the&#xD;
      investigators will repeat the dialysate collections at baseline and after adenosine&#xD;
      infusions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interstitial levels of adenosine</measure>
    <time_frame>After each dose of intrabrachial adenosine</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>To determine if there is an increase in adenosine interstitial levels in the forearm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dipyridamole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To determine if there is an increase in adenosine interstitial levels in the forearm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ticagrelor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To determine if there is an increase in adenosine interstitial levels in the forearm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adenosine</intervention_name>
    <description>Adenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes,</description>
    <arm_group_label>Dipyridamole</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Ticagrelor</arm_group_label>
    <other_name>Adenocard</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects will be healthy volunteers, without significant pulmonary, cardiovascular&#xD;
             gastrointestinal, hematological or renal diseases&#xD;
&#xD;
          2. Not taking any regular medications&#xD;
&#xD;
          3. Able to provide signed consent prior to study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of asthma&#xD;
&#xD;
          2. Pregnancy&#xD;
&#xD;
          3. Exposure to an investigational drug in the last 2 months.&#xD;
&#xD;
          4. Known hypersensitivity to study medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Italo Biaggioni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Autonomic Dysfunction Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Italo Biaggioni</investigator_full_name>
    <investigator_title>Professor of Medicine and Pharmacology</investigator_title>
  </responsible_party>
  <keyword>Adenosine</keyword>
  <keyword>Ticagrelor</keyword>
  <keyword>Microdialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenosine</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/NCT01690884
org study id: 120477
nct id: NCT01690884
lead sponsor: 
has dmc: No
The investigators are trying to determine if a single dose of Ticagrelor will increase
      delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with
      adenosine reuptake blockade.
The investigators will compare adenosine interstitial levels using a parallel design study
      with three groups of subjects. Forearm interstitial adenosine levels will be measured at
      baseline and after intrabrachial infusion of adenosine at two doses. Subjects will then
      randomly receive Ticagrelor 180 mg, Dipyridamole 200 mg, or placebo. Two hours later the
      investigators will repeat the dialysate collections at baseline and after adenosine
      infusions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Interstitial levels of adenosine
time frame: After each dose of intrabrachial adenosine
arm group label: Placebo
arm group type: Placebo Comparator
description: To determine if there is an increase in adenosine interstitial levels in the forearm.
arm group label: Dipyridamole
arm group type: Active Comparator
description: To determine if there is an increase in adenosine interstitial levels in the forearm.
arm group label: Ticagrelor
arm group type: Experimental
description: To determine if there is an increase in adenosine interstitial levels in the forearm.
intervention type: Drug
intervention name: Adenosine
description: Adenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes,
arm group label: Dipyridamole
arm group label: Placebo
arm group label: Ticagrelor
other name: Adenocard
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Italo Biaggioni, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Italo Biaggioni
investigator title: Professor of Medicine and Pharmacology
mesh term: Coronary Artery Disease
mesh term: Adenosine