<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/NCT03016611</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-16-3634</org_study_id>
    <nct_id>NCT03016611</nct_id>
  </id_info>
  <brief_title>Chewing Ticagrelor Versus Prasugrel in ST-elevation Myocardial Infarction - A Platelet Reactivity Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine the efficacy of chewing Ticagrelor versus Prasugrel in ST-elevation Myocardial&#xD;
      Infarction (STEMI) patients on platelet reactivity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <primary_completion_date type="Anticipated">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after Ticagrelor/Prasugrel LD</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percent of patients with a high residual platelet reactivity (PRU &gt; 208) 1 hour, 4-6 hours after Ticagrelor/Prasugrel LD</measure>
    <time_frame>4-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of dyspnea and/or symptomatic bradycardia</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>STEMI</condition>
  <arm_group>
    <arm_group_label>Chewing Ticagrelor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Chewing Prasugrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chewing Ticagrelor LD</intervention_name>
    <description>180 mg Chewing Ticagrelor</description>
    <arm_group_label>Chewing Prasugrel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chewing Prasugrel LD</intervention_name>
    <description>60 mg Chewing Prasugrel</description>
    <arm_group_label>Chewing Ticagrelor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients presenting with STEMI&#xD;
&#xD;
          2. Informed, written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 18 years or Age &gt; 75 years&#xD;
&#xD;
          2. Active bleeding; bleeding diathesis; coagulopathy&#xD;
&#xD;
          3. Increased risk of bradycardic events&#xD;
&#xD;
          4. History of gastrointestinal or genitourinary bleeding &lt;2 months&#xD;
&#xD;
          5. Major surgery in the last 6 weeks&#xD;
&#xD;
          6. History of intracranial bleeding or structural abnormalities&#xD;
&#xD;
          7. Suspected aortic dissection&#xD;
&#xD;
          8. Any other condition that may put the patient at risk or influence study results or&#xD;
             investigator's opinion (severe hemodynamic instability, unconsciousness, known&#xD;
             malignancies or other comorbid conditions with life expectancy &lt;1 year)&#xD;
&#xD;
          9. Administration in the week before the index event of clopidogrel, ticlopidine,&#xD;
             prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or&#xD;
             fondaparinux.&#xD;
&#xD;
         10. Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers,&#xD;
             CYP3A with narrow therapeutic windows&#xD;
&#xD;
         11. Known relevant hematological deviations: Hb &lt;10 g/dl, PLT&lt;100x10^9/l&#xD;
&#xD;
         12. Use of coumadin derivatives within the last 7 days&#xD;
&#xD;
         13. Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine&#xD;
&#xD;
         14. Known severe liver disease, severe renal failure&#xD;
&#xD;
         15. Known allergy to the study medications&#xD;
&#xD;
         16. Pregnancy&#xD;
&#xD;
         17. Human immunodeficiency virus treatment&#xD;
&#xD;
         18. The use of IIBIIIA receptor antagonists in the 48 hours before enrollment (if&#xD;
             abciximab use then in the last 14 days).&#xD;
&#xD;
         19. If the patients cannot sign percutaneous coronary intervention (PCI) informed consent&#xD;
             for any reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elad Asher, MD; MHA</last_name>
    <phone>+972-52-6667131</phone>
    <email>el.asher@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sheba Medical center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 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 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Elad Asher</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
  </condition_browse>
  <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>
  <!-- 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/NCT03016611
org study id: SHEBA-16-3634
nct id: NCT03016611
lead sponsor: 
has dmc: No
To examine the efficacy of chewing Ticagrelor versus Prasugrel in ST-elevation Myocardial
      Infarction (STEMI) patients on platelet reactivity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after Ticagrelor/Prasugrel LD
time frame: 1 hour
measure: The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after Ticagrelor/Prasugrel LD
time frame: 4-6 hours
measure: Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events
time frame: 30 days
measure: Occurrence of dyspnea and/or symptomatic bradycardia
time frame: 30 days
arm group label: Chewing Ticagrelor
arm group type: Active Comparator
arm group label: Chewing Prasugrel
arm group type: Experimental
intervention type: Drug
intervention name: Chewing Ticagrelor LD
description: 180 mg Chewing Ticagrelor
arm group label: Chewing Prasugrel
intervention type: Drug
intervention name: Chewing Prasugrel LD
description: 60 mg Chewing Prasugrel
arm group label: Chewing Ticagrelor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Elad Asher, MD; MHA
phone: +972-52-6667131
email: el.asher@gmail.com
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Elad Asher
investigator title: Principal Investigator
mesh term: Acute Coronary Syndrome
mesh term: Ticagrelor
mesh term: Prasugrel Hydrochloride