<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/NCT04400760</url>
  </required_header>
  <id_info>
    <org_study_id>CREC-SA.0284/03/2020</org_study_id>
    <nct_id>NCT04400760</nct_id>
  </id_info>
  <brief_title>The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts.</brief_title>
  <acronym>EDGE</acronym>
  <official_title>The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts: The EDGE Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of The West Indies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of The West Indies</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, reduce the&#xD;
      likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of&#xD;
      which the mechanism has not been fully elucidated. The mechanistic effects of dapagliflozin&#xD;
      on platelet function profiles have not yet been ascertained. It remains unclear if this&#xD;
      reduction in cardiovascular death is mediated by decreased platelet reactivity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes is highly prevalent in our setting. Dapagliflozin is now considered first-line&#xD;
      treatment for diabetes, especially in the cardiovascular arena. The standard prescribed&#xD;
      dosages of dapagliflozin will be employed in the research study (5 or 10 mg once daily). The&#xD;
      reason the study team is interested in performing this study in our local setting is that if&#xD;
      dapagliflozin does show a beneficial effect with either diabetic control or an antiplatelet&#xD;
      effect, the team can then inform the Ministry of Health to acquire these relatively expensive&#xD;
      medications in place of the older, less effective anti-diabetic drugs. The team has to&#xD;
      demonstrate that they work effectively and safely in our population before approaching&#xD;
      regulatory bodies with a robust recommendation that they are made available in the public&#xD;
      healthcare sector. The patients that are to be selected will be relatively controlled on&#xD;
      their current regimen, and thus not &quot;miss out&quot; on these medications after the study has been&#xD;
      concluded as they are all available on the chronic disease assistance program (CDAP) such as&#xD;
      metformin, gliclazide and insulin therapies. The study will aim to determine if dapagliflozin&#xD;
      does demonstrate other latent antiplatelet effects that can potentially affect the&#xD;
      cardiovascular/hematologic systems that have not investigated before.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The study will be of a prospective, open-label trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago will be screened for potential eligibility.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet Reactions Units pre-DAPA Tx and post-DAPA Tx</measure>
    <time_frame>2 weeks</time_frame>
    <description>Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Platelet Dysfunction</condition>
  <arm_group>
    <arm_group_label>DAPA Tx</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAPA Tx</intervention_name>
    <description>The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.</description>
    <arm_group_label>DAPA Tx</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. between 18 and 74 years of age,&#xD;
&#xD;
          2. have stable coronary artery disease and diabetes mellitus, already on DAPT with&#xD;
             aspirin and clopidogrel for at least 6 months,&#xD;
&#xD;
          3. not on any physician-prescribed medications or complementary/alternative therapies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. presence of active internal bleeding or history of bleeding diathesis or clinical&#xD;
             findings associated with an increased risk of bleeding,&#xD;
&#xD;
          2. history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial&#xD;
             neoplasm, arteriovenous malformation, or aneurysm,&#xD;
&#xD;
          3. history of clinical and/or hemodynamic instability,&#xD;
&#xD;
          4. within 1 month of placement of a bare-metal stent,&#xD;
&#xD;
          5. within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,&#xD;
&#xD;
          6. planned coronary revascularization,&#xD;
&#xD;
          7. treatment with fibrin-specific fibrinolytic therapy &lt;24 h or non-fibrin-specific&#xD;
             fibrinolytic therapy &lt;48 h,&#xD;
&#xD;
          8. use of an oral anticoagulation agent or international normalized ratio &gt;1.5,&#xD;
&#xD;
          9. body weight &lt;60 kg,&#xD;
&#xD;
         10. age &gt;75 years,&#xD;
&#xD;
         11. hemoglobin &lt;10 g/dL,&#xD;
&#xD;
         12. platelet count &lt;100×106/μL,&#xD;
&#xD;
         13. creatinine &gt;2 mg/dL,&#xD;
&#xD;
         14. hepatic enzymes &gt;2.5 times the upper limit of normal,&#xD;
&#xD;
         15. pregnancy and/or lactation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naveen A Seecheran, MBBS MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of The West Indies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eric Williams Medical Sciences Complex</name>
      <address>
        <city>Port Of Spain</city>
        <state>North Central</state>
        <zip>00000</zip>
        <country>Trinidad and Tobago</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Trinidad and Tobago</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of The West Indies</investigator_affiliation>
    <investigator_full_name>Naveen Seecheran</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>dapagliflozin</keyword>
  <keyword>SGLT2i</keyword>
  <!-- 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/NCT04400760
org study id: CREC-SA.0284/03/2020
nct id: NCT04400760
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, reduce the
      likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of
      which the mechanism has not been fully elucidated. The mechanistic effects of dapagliflozin
      on platelet function profiles have not yet been ascertained. It remains unclear if this
      reduction in cardiovascular death is mediated by decreased platelet reactivity.
Diabetes is highly prevalent in our setting. Dapagliflozin is now considered first-line
      treatment for diabetes, especially in the cardiovascular arena. The standard prescribed
      dosages of dapagliflozin will be employed in the research study (5 or 10 mg once daily). The
      reason the study team is interested in performing this study in our local setting is that if
      dapagliflozin does show a beneficial effect with either diabetic control or an antiplatelet
      effect, the team can then inform the Ministry of Health to acquire these relatively expensive
      medications in place of the older, less effective anti-diabetic drugs. The team has to
      demonstrate that they work effectively and safely in our population before approaching
      regulatory bodies with a robust recommendation that they are made available in the public
      healthcare sector. The patients that are to be selected will be relatively controlled on
      their current regimen, and thus not "miss out" on these medications after the study has been
      concluded as they are all available on the chronic disease assistance program (CDAP) such as
      metformin, gliclazide and insulin therapies. The study will aim to determine if dapagliflozin
      does demonstrate other latent antiplatelet effects that can potentially affect the
      cardiovascular/hematologic systems that have not investigated before.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study will be of a prospective, open-label trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago will be screened for potential eligibility.
primary purpose: Treatment
masking: None (Open Label)
measure: Platelet Reactions Units pre-DAPA Tx and post-DAPA Tx
time frame: 2 weeks
description: Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin
arm group label: DAPA Tx
arm group type: Other
description: This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks.
intervention type: Drug
intervention name: DAPA Tx
description: The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.
arm group label: DAPA Tx
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Naveen A Seecheran, MBBS MSc
role: Principal Investigator
affiliation: The University of The West Indies
facility: 
country: Trinidad and Tobago
responsible party type: Principal Investigator
investigator affiliation: The University of The West Indies
investigator full name: Naveen Seecheran
investigator title: Principal Investigator