xml: <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/NCT06009874</url>
    </required_header>
    <id_info>
      <org_study_id>35541/6/22</org_study_id>
      <nct_id>NCT06009874</nct_id>
    </id_info>
    <brief_title>Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI</brief_title>
    <official_title>Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mohammad Hussien Tantawy Soliman</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to investigate the effect of early administration of DAPA during ischemia and&#xD;
        before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection&#xD;
        from HF, and renoprotection from AKI in patients with AMI.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        DAPA was approved for HF patients, but there is no sufficient data about its efficacy on&#xD;
        patients with AMI and if it can protect from the development of HF after AMI.&#xD;
  &#xD;
        the investigators aim to investigate the effect of DAPA on patients who presented with AMI&#xD;
        when administered as early as possible before pPCI and to be continued for three months after&#xD;
        there.&#xD;
  &#xD;
        the effect of DAPA on infarct size, cardiac biomarkers will be assessed during the follow-up&#xD;
        period&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
    <phase>N/A</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>Prevention</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>difference in infarct size</measure>
      <time_frame>3 months</time_frame>
      <description>infarct size measurement (percentage) for both groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>difference in NT-proBNP level</measure>
      <time_frame>3 months</time_frame>
      <description>NT-proBNP level (pg/ml) for both groups</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in eGFR</measure>
      <time_frame>3 months</time_frame>
      <description>Decline in eGFR (ml/min) for both groups</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>Dapagliflozin group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients with MI will be treated with DAPA 10 mg once daily for three months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>patients with MI will be treated with a matching placebo once daily for three months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dapagliflozin 10mg Tab</intervention_name>
      <description>patients will be treated with DAPA 10 mg once daily for three months</description>
      <arm_group_label>Dapagliflozin group</arm_group_label>
      <other_name>DAPA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>patients will be treated with a placebo tab once daily for three months</description>
      <arm_group_label>Placebo group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with ST-elevation myocardial infarction (STEMI).&#xD;
  &#xD;
            2. STEMI was defined according to the Fourth Universal Definition of AMI.&#xD;
  &#xD;
            3. 18 - 80 years of age.&#xD;
  &#xD;
            4. Diabetics or non-diabetics.&#xD;
  &#xD;
            5. eGFR &gt; 45 ml/min/1.73m2.&#xD;
  &#xD;
            6. Blood pressure before first drug dosing &gt;110/70 mmHg.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Cardiogenic shock.&#xD;
  &#xD;
            2. Hypoglycemia.&#xD;
  &#xD;
            3. History of diabetic ketoacidosis.&#xD;
  &#xD;
            4. Genital and urinary infections.&#xD;
  &#xD;
            5. History of AMI.&#xD;
  &#xD;
            6. Stent thrombosis.&#xD;
  &#xD;
            7. Previous coronary artery bypass surgery.&#xD;
  &#xD;
            8. Severe hepatic insufficiency.&#xD;
  &#xD;
            9. Advanced cancer patients.&#xD;
  &#xD;
           10. Blood pH &lt; 7.32.&#xD;
  &#xD;
           11. Known allergy to SGLT-2 inhibitors.&#xD;
  &#xD;
           12. Hemodynamic instability.&#xD;
  &#xD;
           13. Females of childbearing potential without adequate contraceptive methods.&#xD;
  &#xD;
           14. Patients currently on or have received any SGLT-2 inhibitors.&#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_contact>
      <last_name>Mohammad Soliman</last_name>
      <phone>+201003474565</phone>
      <email>dr.mhtantawy@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mohammad Soliman</name>
        <address>
          <city>Shibīn Al Kawm</city>
          <state>Menofia</state>
          <zip>32741</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohammad Soliman</last_name>
        <email>dr.mhtantawy@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Mohammad Hussien Tantawy Soliman</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>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>Dapagliflozin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009874
  org study id: 35541/6/22
  nct id: NCT06009874
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to investigate the effect of early administration of DAPA during ischemia and
        before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection
        from HF, and renoprotection from AKI in patients with AMI.
  DAPA was approved for HF patients, but there is no sufficient data about its efficacy on
        patients with AMI and if it can protect from the development of HF after AMI.
  
        the investigators aim to investigate the effect of DAPA on patients who presented with AMI
        when administered as early as possible before pPCI and to be continued for three months after
        there.
  
        the effect of DAPA on infarct size, cardiac biomarkers will be assessed during the follow-up
        period
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  measure: difference in infarct size
  time frame: 3 months
  description: infarct size measurement (percentage) for both groups
  measure: difference in NT-proBNP level
  time frame: 3 months
  description: NT-proBNP level (pg/ml) for both groups
  measure: Difference in eGFR
  time frame: 3 months
  description: Decline in eGFR (ml/min) for both groups
  arm group label: Dapagliflozin group
  arm group type: Active Comparator
  description: patients with MI will be treated with DAPA 10 mg once daily for three months.
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: patients with MI will be treated with a matching placebo once daily for three months.
  intervention type: Drug
  intervention name: Dapagliflozin 10mg Tab
  description: patients will be treated with DAPA 10 mg once daily for three months
  arm group label: Dapagliflozin group
  other name: DAPA
  intervention type: Drug
  intervention name: Placebo
  description: patients will be treated with a placebo tab once daily for three months
  arm group label: Placebo group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Mohammad Soliman
  phone: +201003474565
  email: dr.mhtantawy@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tanta University
  investigator full name: Mohammad Hussien Tantawy Soliman
  investigator title: Principal Investigator
  mesh term: Myocardial Infarction
  mesh term: Infarction
  mesh term: Dapagliflozin
  sharing ipd: No