<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/NCT03027934</url>
  </required_header>
  <id_info>
    <org_study_id>ESR-14-10619</org_study_id>
    <nct_id>NCT03027934</nct_id>
  </id_info>
  <brief_title>A Single Center Study to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response</brief_title>
  <official_title>A Single Center, Randomized, Open Label, Crossover Study With Ticagrelor and Prasugrel to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CirQuest Labs, LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CirQuest Labs, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples&#xD;
      obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in&#xD;
      a cross-over design.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study population difficult to recruit&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 28, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Aggregation Response</measure>
    <time_frame>23 hr Day 5</time_frame>
    <description>Comparison of aggregation response using ADP in subjects receiving prasurgrel versus ticagrelor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reticulated Platelet Reactivity Index (PRI)</measure>
    <time_frame>23 hr Day 5</time_frame>
    <description>Comparison of PRI as measured by VASP in subjects receiving ticagrelor versus subjects receiving prasugrel</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor</intervention_name>
    <description>Ticagrelor, 90mg twice daily</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>Brilinta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prasugrel</intervention_name>
    <description>Prasurgrel, 10mg once daily</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>Effient</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent prior to any study specific procedures&#xD;
&#xD;
          2. Male or female aged 18 to 70 years, inclusive.&#xD;
&#xD;
          3. Documented current medical history of diabetes controlled by either medication or diet&#xD;
             and/or exercise.&#xD;
&#xD;
          4. Women must have a negative urine pregnancy test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating females, or females of child-bearing potential (i.e., those who&#xD;
             are not chemically or surgically sterilized or who are not post-menopause) or those&#xD;
             who are not willing to use a medically accepted method of contraception that is&#xD;
             considered reliable in the judgement of the investigator throughout the duration of&#xD;
             the study or females who have a positive pregnancy test at screening.&#xD;
&#xD;
          2. Weight of less than 135 lbs.&#xD;
&#xD;
          3. Currently prescribed and taking clopidogrel (generic or Plavix), ticagrelor (Brilinta)&#xD;
             or prasugrel (Effient) or have taken within the past 10 days.&#xD;
&#xD;
          4. Current medications:&#xD;
&#xD;
               1. PAR-1 antagonist (vorapaxar/Zontivity) or within the last month.&#xD;
&#xD;
               2. Phosphodiesterase inhibitors such as cilostazol (Pletal).&#xD;
&#xD;
               3. Glycoprotein IIb/IIIa inhibitors or within the last ten days (Integrilin,&#xD;
                  Aggrastat, ReoPro).&#xD;
&#xD;
               4. Adenosine reuptake inhibitors such as dipyridamole (Aggrenox, Persantine)&#xD;
&#xD;
               5. Coumadin.&#xD;
&#xD;
               6. Heparin including low molecular weight heparin.&#xD;
&#xD;
               7. Factor Xa inhibitors (e.g., enoxaparin, rivaroxaban, apixaban, and edoxaban).&#xD;
&#xD;
               8. Direct thrombin inhibitors (e.g., hirudin, bivalirudin, dabigatran.&#xD;
&#xD;
               9. Concomitant therapy with strong CYP3A inhibitors, such as atanazavir,&#xD;
                  clarithromycin, indinavir, itraconazole, ketoconazole, nefazadone, nelfinavir,&#xD;
                  ritonavir, saquinavir, telithromycin, and voriconizole,&#xD;
&#xD;
              10. Concomitant therapy with potent CYP3A inducers, such as rifampin, phenytoin,&#xD;
                  carbamazepine, and phenobarbital.&#xD;
&#xD;
          5. Increased bleeding risk including:&#xD;
&#xD;
               1. Recent (within 30 days) GI bleeding&#xD;
&#xD;
               2. Active pathological bleeding&#xD;
&#xD;
               3. Any history of intracranial, intraocular, retroperitoneal, or spinal bleeding&#xD;
&#xD;
               4. Prior history of transient ischemic attack or stroke&#xD;
&#xD;
               5. Recent (within 3 months) major trauma&#xD;
&#xD;
               6. Sustained uncontrolled hypertension (systolic blood pressure [SBP] &gt; 180mmHg or&#xD;
                  diastolic blood pressure [DBP] &gt; 100mmHg&#xD;
&#xD;
               7. History of hemorrhagic disorders that can increase the risk of bleeding (e.g.,&#xD;
                  hemophilia, von Willebrand's disease)&#xD;
&#xD;
               8. Patients that have used within 30 days of screening, any oral or parenteral&#xD;
                  anti-thrombotic agent.&#xD;
&#xD;
               9. Platelet count less than 100,000 mm3 or hemoglobin &lt; 10g/dL&#xD;
&#xD;
          6. Contraindication or other reason that ticagrelor or prasugrel should not be&#xD;
             administered (e.g., known hypersensitivity to medication or any medication component)&#xD;
&#xD;
          7. A history of alcohol and/or substance abuse that could interfere with conduct of the&#xD;
             trial.&#xD;
&#xD;
          8. Known active or recurrent hepatic disorder (including cirrhosis, hepatitis B and&#xD;
             hepatitis C, or confirmed (ALT/AST) levels &gt; 3 times ULN or total bilirubin &gt; 2 times&#xD;
             ULN at screening.&#xD;
&#xD;
          9. Scheduled for revascularization (e.g., PCI, CABG) during the study period.&#xD;
&#xD;
         10. Any Acute Coronary Syndrome (ACS) event within the past 6 months.&#xD;
&#xD;
         11. Participation in another investigational drug or device study within 30 days of&#xD;
             dosing.&#xD;
&#xD;
         12. Any acute or chronic unstable condition in the past 30 days or other condition which,&#xD;
             in the opinion of the investigator, may either put the subject at risk or influence&#xD;
             the result of the study (e.g., active cancer, risk for non-compliance, risk for lost&#xD;
             to follow-up).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jayaprakash Kotha</last_name>
    <role>Principal Investigator</role>
    <affiliation>CirQuest Labs</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ticagrelor</mesh_term>
    <mesh_term>Prasugrel Hydrochloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03027934
org study id: ESR-14-10619
nct id: NCT03027934
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples
      obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in
      a cross-over design.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Aggregation Response
time frame: 23 hr Day 5
description: Comparison of aggregation response using ADP in subjects receiving prasurgrel versus ticagrelor
measure: Reticulated Platelet Reactivity Index (PRI)
time frame: 23 hr Day 5
description: Comparison of PRI as measured by VASP in subjects receiving ticagrelor versus subjects receiving prasugrel
arm group label: Group 1
arm group type: Active Comparator
arm group label: Group 2
arm group type: Active Comparator
intervention type: Drug
intervention name: Ticagrelor
description: Ticagrelor, 90mg twice daily
arm group label: Group 1
arm group label: Group 2
other name: Brilinta
intervention type: Drug
intervention name: Prasugrel
description: Prasurgrel, 10mg once daily
arm group label: Group 1
arm group label: Group 2
other name: Effient
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jayaprakash Kotha
role: Principal Investigator
affiliation: CirQuest Labs
responsible party type: Sponsor
mesh term: Ticagrelor
mesh term: Prasugrel Hydrochloride
sharing ipd: No