<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/NCT03251859</url>
  </required_header>
  <id_info>
    <org_study_id>CMUMK202H</org_study_id>
    <nct_id>NCT03251859</nct_id>
  </id_info>
  <brief_title>Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot Study</brief_title>
  <official_title>A Randomized, Open-label, Pharmacodynamic and Pharmacokinetic Trial Assessing the Effect of Lowering Ticagrelor Maintenance Dose Early After Myocardial Infarction on Platelet Inhibition (ELECTRA Pilot Study).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Collegium Medicum w Bydgoszczy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Collegium Medicum w Bydgoszczy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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 ELECTRA pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic&#xD;
      trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet&#xD;
      inhibition in stable patients who recently underwent acute myocardial infarction and were&#xD;
      treated with percutaneous coronary intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Actual">February 23, 2018</completion_date>
  <primary_completion_date type="Actual">February 23, 2018</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet Reactivity Assessed with the VASP assay</measure>
    <time_frame>45 days</time_frame>
    <description>Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Platelet Reactivity Assessed with Multiple Electrode Aggregometry</measure>
    <time_frame>45 days</time_frame>
    <description>Platelet inhibition evaluated with Multiple Electrode Aggregometry 45 days after myocardial infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With High Platelet Reactivity according to the VASP assay</measure>
    <time_frame>45 days</time_frame>
    <description>Number of Patients With High Platelet Reactivity according to the VASP assay 45 days after myocardial infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry</measure>
    <time_frame>45 days</time_frame>
    <description>Percentage of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry 45 days after myocardial infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of Ticagrelor</measure>
    <time_frame>45 days</time_frame>
    <description>Evaluation of ticagrelor plasma concentration 45 days after myocardial infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of AR-C124910XX</measure>
    <time_frame>45 days</time_frame>
    <description>Evaluation of ticagrelor active metabolite plasma concentration 45 days after myocardial infarction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Standard ticagrelor maintenance dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ticagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reduced ticagrelor maintenance dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ticagrelor 90 mg twice daily for the first 30 days after myocardial infarction treated with percutaneous coronary intervention, then reduction of the maintenance dose to ticagrelor 60 mg twice daily for the next 15 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor 90 mg</intervention_name>
    <description>Ticagrelor 90 mg twice daily</description>
    <arm_group_label>Reduced ticagrelor maintenance dose</arm_group_label>
    <arm_group_label>Standard ticagrelor maintenance dose</arm_group_label>
    <other_name>Brilique 90 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor 60 mg</intervention_name>
    <description>Ticagrelor 60 mg daily</description>
    <arm_group_label>Reduced ticagrelor maintenance dose</arm_group_label>
    <other_name>Brilique 60 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  provision of informed consent prior to any study specific procedures&#xD;
&#xD;
          -  diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment&#xD;
             elevation myocardial infarction according to the Third Universal Definition of&#xD;
             Myocardial Infarction&#xD;
&#xD;
          -  index event treatment with percutaneous coronary intervention&#xD;
&#xD;
          -  male or non-pregnant female, aged 18-80 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindications for ticagrelor&#xD;
&#xD;
          -  further coronary revascularization planned during the first 45 days after myocardial&#xD;
             infarction&#xD;
&#xD;
          -  indications for chronic treatment with oral anticoagulant or low-molecular-weight&#xD;
             heparin&#xD;
&#xD;
          -  active bleeding&#xD;
&#xD;
          -  history of intracranial hemorrhage&#xD;
&#xD;
          -  recent gastrointestinal bleeding (within 30 days)&#xD;
&#xD;
          -  history of coagulation disorders&#xD;
&#xD;
          -  history of moderate or severe hepatic impairment&#xD;
&#xD;
          -  history of major surgery or severe trauma (within 3 months)&#xD;
&#xD;
          -  active neoplastic disease&#xD;
&#xD;
          -  patient requiring dialysis&#xD;
&#xD;
          -  chronic inflammatory disease&#xD;
&#xD;
          -  current therapy with strong CYP3A inhibitors or strong CYP3A inducers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prof. Jacek Kubica, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w Toruniu</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eliano Navarese, Md, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiology Department, Dr. A. Jurasz University Hospital</name>
      <address>
        <city>Bydgoszcz</city>
        <state>Kujawsko-pomorskie</state>
        <zip>85-094</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Collegium Medicum w Bydgoszczy</investigator_affiliation>
    <investigator_full_name>Jacek Kubica</investigator_full_name>
    <investigator_title>Prof. Jacek Kubica, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>platelet reactivity</keyword>
  <keyword>ticagrelor</keyword>
  <keyword>myocardial infarction</keyword>
  <keyword>pharmacodynamics</keyword>
  <keyword>antiplatelet therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ticagrelor</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03251859
org study id: CMUMK202H
nct id: NCT03251859
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The ELECTRA pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic
      trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet
      inhibition in stable patients who recently underwent acute myocardial infarction and were
      treated with percutaneous coronary intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Platelet Reactivity Assessed with the VASP assay
time frame: 45 days
description: Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.
measure: Platelet Reactivity Assessed with Multiple Electrode Aggregometry
time frame: 45 days
description: Platelet inhibition evaluated with Multiple Electrode Aggregometry 45 days after myocardial infarction.
measure: Number of Patients With High Platelet Reactivity according to the VASP assay
time frame: 45 days
description: Number of Patients With High Platelet Reactivity according to the VASP assay 45 days after myocardial infarction.
measure: Number of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry
time frame: 45 days
description: Percentage of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry 45 days after myocardial infarction.
measure: Plasma concentration of Ticagrelor
time frame: 45 days
description: Evaluation of ticagrelor plasma concentration 45 days after myocardial infarction.
measure: Plasma concentration of AR-C124910XX
time frame: 45 days
description: Evaluation of ticagrelor active metabolite plasma concentration 45 days after myocardial infarction.
arm group label: Standard ticagrelor maintenance dose
arm group type: Active Comparator
description: Ticagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention.
arm group label: Reduced ticagrelor maintenance dose
arm group type: Experimental
description: Ticagrelor 90 mg twice daily for the first 30 days after myocardial infarction treated with percutaneous coronary intervention, then reduction of the maintenance dose to ticagrelor 60 mg twice daily for the next 15 days.
intervention type: Drug
intervention name: Ticagrelor 90 mg
description: Ticagrelor 90 mg twice daily
arm group label: Reduced ticagrelor maintenance dose
arm group label: Standard ticagrelor maintenance dose
other name: Brilique 90 mg
intervention type: Drug
intervention name: Ticagrelor 60 mg
description: Ticagrelor 60 mg daily
arm group label: Reduced ticagrelor maintenance dose
other name: Brilique 60 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Prof. Jacek Kubica, MD, PhD
role: Principal Investigator
affiliation: Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w Toruniu
last name: Eliano Navarese, Md, PhD
role: Principal Investigator
affiliation: Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Collegium Medicum w Bydgoszczy
investigator full name: Jacek Kubica
investigator title: Prof. Jacek Kubica, MD, PhD
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Ticagrelor
sharing ipd: Undecided