<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/NCT01684813</url>
  </required_header>
  <id_info>
    <org_study_id>VERDI study</org_study_id>
    <nct_id>NCT01684813</nct_id>
  </id_info>
  <brief_title>VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel</brief_title>
  <acronym>VERDI</acronym>
  <official_title>A Randomized Study With Loading Dose of Prasugrel Opposed to the Standard Dose of Clopidogrel in Type 2 Diabetic Patients in Acute Coronary Syndrome, Revascularized Through Drug-eluting Stent.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Pública Andaluza para la gestión de la Investigación en Sevilla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Andaluz Health Service</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Pública Andaluza para la gestión de la Investigación en Sevilla</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if, in type 2 diabetic patients undergoing&#xD;
      treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading&#xD;
      dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of&#xD;
      75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at&#xD;
      24-36 hours of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The VERDI study consists on a randomized, mono-center study comparing the treatment plan of a&#xD;
      loading dose of prasugrel as opposed to the standard dose in type 2 diabetic patients, who&#xD;
      suffer acute coronary syndrome, revascularized through an invasive percutaneous strategy with&#xD;
      a stent. The aim of this study is to determine if, in type 2 diabetic patients undergoing&#xD;
      treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading&#xD;
      dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of&#xD;
      75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at&#xD;
      24-36 hours of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Number of patients who achieve inhibition of platelet aggregation greater that 50%</measure>
    <time_frame>24 to 36 hours post-PCI</time_frame>
    <description>The principal objective is to determine whether in type 2 diabetic patients who are non-responsive to clopidogrel at habitual doses and who receive treatment through percutaneous coronary intervention (PCI) with a stent, a treatment plan with a loading dose of prasugrel (60 mg) followed by 1 cp (10 mg) once a day, is superior to a standard dose of 75 mg clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events as a measure of safety and tolerability</measure>
    <time_frame>30 days</time_frame>
    <description>To evaluate the safety of treatment with prasugrel in comparison with the standard treatment with clopidogrel in terms of the appearance of secondary effects (severe bleeding, thrombocytopenia, neutropenia, gastrointestinal changes, thrombotic thrombocytopenic purpura).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy.</measure>
    <time_frame>30 days.</time_frame>
    <description>To assess the results in different sub-groups and analyze the combined endpoint of cardiovascular death, MI or recurrent ischemia at 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy</measure>
    <time_frame>30 days.</time_frame>
    <description>To analyze the characteristics of patients who are non-responsive to anti-aggregation therapy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Diabetes Mellitus Type II</condition>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Clopidogrel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive after PCI the standard dose of clopidogrel, a daily dose of 75 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prasugrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive after PCI a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by a daily dose of prasugrel (10 mg tablet).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prasugrel.</intervention_name>
    <description>Patients in this group will receive a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by at least dose of 10 mg prasugrel (1 x 10 mg tablet). Beyond the second day after PCI, these patients will receive double antiaggregation therapy according to their physician´s criteria.</description>
    <arm_group_label>Prasugrel</arm_group_label>
    <other_name>Efient, Eli Lilly</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <description>Patients in this group will receive the standard dose of clopidogrel, a daily dose of 75 mg. Beyond the second day post-PCI, these patients will receive double anti aggregation therapy according to their physician's criteria.</description>
    <arm_group_label>Clopidogrel</arm_group_label>
    <other_name>Agrelan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Type 2 diabetic patients with acute coronary syndrome with non-ST segment elevation&#xD;
             who are undergoing a percutaneous coronary intervention (PCI) with a coronary stent.&#xD;
&#xD;
          2. Patients who are non-responsive on the platelet anti-aggregation test with standard&#xD;
             doses of clopidogrel will be randomized.&#xD;
&#xD;
          3. Participants must sign an informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;18 years or &gt;80 years.&#xD;
&#xD;
          2. Patients with acute coronary syndrome with ST segment elevation.&#xD;
&#xD;
          3. Pregnancy previous to or during the study.&#xD;
&#xD;
          4. The use of oral anticoagulants in the last 10 days with an INR &gt;1.5 or who plan to use&#xD;
             them during the follow-up period (1 year).&#xD;
&#xD;
          5. Antithrombotic treatment with GP IIb/IIIa inhibitors.&#xD;
&#xD;
          6. Contraindication for the use of prasugrel and/or clopidogrel and/or aspirin:&#xD;
&#xD;
               -  Antecedents of pharmacologic allergy to thienopyridine derivatives or aspirin.&#xD;
&#xD;
               -  Antecedents of clinically significant or persistent thrombocytopenia or&#xD;
                  neutropenia.&#xD;
&#xD;
          7. Active bleeding or significant increase of risk of hemorrhage such as severe hepatic&#xD;
             insufficiency, peptic ulcer present, proliferative diabetic retinopathy, antecedents&#xD;
             of severe systemic bleeding, gastrointestinal bleeding, macrohematuria, intraocular&#xD;
             hemorrhage, hemorrhagic stroke, or intracranial bleeding), or other antecedents of&#xD;
             bleeding diathesis or coagulopathy.&#xD;
&#xD;
          8. Patients with previous TIA or CVA.&#xD;
&#xD;
          9. Patients weighing &lt;60 Kg.&#xD;
&#xD;
         10. Hemoglobin &lt;10.5 g/dl, or Hematocrit &lt;30%.&#xD;
&#xD;
         11. Severe left ventricular systolic dysfunction, EF &lt;35%.&#xD;
&#xD;
         12. Renal insufficiency with creatinine levels &gt;2 mg/dl.&#xD;
&#xD;
         13. Previous inclusion of the patient in another study.&#xD;
&#xD;
         14. Treatment in research (medication or device) in the last 30 days prior.&#xD;
&#xD;
         15. Medical, geographical, or social factors that would make participation in the study&#xD;
             impractical, such as the incapacity to provide written informed consent and to&#xD;
             understand the complete meaning of informed consent, or the refusal of the patient to&#xD;
             participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Seville</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes mellitus.</keyword>
  <keyword>Acute coronary syndrome.</keyword>
  <keyword>Percutaneous coronary intervention.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</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/NCT01684813
org study id: VERDI study
nct id: NCT01684813
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine if, in type 2 diabetic patients undergoing
      treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading
      dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of
      75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at
      24-36 hours of treatment.
The VERDI study consists on a randomized, mono-center study comparing the treatment plan of a
      loading dose of prasugrel as opposed to the standard dose in type 2 diabetic patients, who
      suffer acute coronary syndrome, revascularized through an invasive percutaneous strategy with
      a stent. The aim of this study is to determine if, in type 2 diabetic patients undergoing
      treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading
      dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of
      75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at
      24-36 hours of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients who achieve inhibition of platelet aggregation greater that 50%
time frame: 24 to 36 hours post-PCI
description: The principal objective is to determine whether in type 2 diabetic patients who are non-responsive to clopidogrel at habitual doses and who receive treatment through percutaneous coronary intervention (PCI) with a stent, a treatment plan with a loading dose of prasugrel (60 mg) followed by 1 cp (10 mg) once a day, is superior to a standard dose of 75 mg clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.
measure: Number of participants with adverse events as a measure of safety and tolerability
time frame: 30 days
description: To evaluate the safety of treatment with prasugrel in comparison with the standard treatment with clopidogrel in terms of the appearance of secondary effects (severe bleeding, thrombocytopenia, neutropenia, gastrointestinal changes, thrombotic thrombocytopenic purpura).
measure: Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy.
time frame: 30 days.
description: To assess the results in different sub-groups and analyze the combined endpoint of cardiovascular death, MI or recurrent ischemia at 30 days.
measure: Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy
time frame: 30 days.
description: To analyze the characteristics of patients who are non-responsive to anti-aggregation therapy.
arm group label: Clopidogrel
arm group type: Active Comparator
description: This group will receive after PCI the standard dose of clopidogrel, a daily dose of 75 mg.
arm group label: Prasugrel
arm group type: Experimental
description: This group will receive after PCI a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by a daily dose of prasugrel (10 mg tablet).
intervention type: Drug
intervention name: Prasugrel.
description: Patients in this group will receive a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by at least dose of 10 mg prasugrel (1 x 10 mg tablet). Beyond the second day after PCI, these patients will receive double antiaggregation therapy according to their physician´s criteria.
arm group label: Prasugrel
other name: Efient, Eli Lilly
intervention type: Drug
intervention name: Clopidogrel
description: Patients in this group will receive the standard dose of clopidogrel, a daily dose of 75 mg. Beyond the second day post-PCI, these patients will receive double anti aggregation therapy according to their physician's criteria.
arm group label: Clopidogrel
other name: Agrelan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Syndrome
mesh term: Clopidogrel
mesh term: Prasugrel Hydrochloride