<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220809055645N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-17</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Empagliflozin on outcomes of patients with myocardial infarction undergoing primary PCI</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Empagliflozin on outcomes of patients with myocardial infarction undergoing primary Percutaneous coronary intervention  (PCI):a randomized double-blind clinical trial with placebo</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75261</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 54 patients according to inclusion criteria, with  block randomization group with 1:1 ratio as 2 groups(A: intervention and B: placebo) will enter this study. with Blocking randomization we give each patient a number from 1 to 54. Then a table with 9 rows named block that each block has 6 segments, will be considered and then the numbers will be placed respectively in the rows. After all numbers placed in blocks, all patients with code A, receive drug andpatients with code B receive placebo. 
https://www.sealedenvelope.com is used for randomization, Blinding description: Patients and researchers are blind. A third person out of the study, based on randomization allocates the placebo and drug to researcher.</study_design>
      <phase>3</phase>
      <hc_freetext>ST Elevation myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receiving Empagliflozin 10 mg 1 tablet daily. Made by Actover co. Intervention 2: Control group: Receiving Placebo (cellulose micro crystal tablet). 1 tablet daily.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data except personal information (name, contact number, file number) can be published.

When:
After publishing the results

To whom:
Available to service providers such as doctors and nurses.

Conditions:
After obtaining permission from the project manager, the information will be usable.

Where to obtain:
Project manager

How to obtain:
By email to the project manager

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Baharvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kooye Bayani</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55588</zip>
        <telephone>+98 13 3366 4282</telephone>
        <email>dr.baharcardio@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Baharvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kooye Bayani</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55588</zip>
        <telephone>+98 13 3366 4282</telephone>
        <email>dr.baharcardio@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with ST segment elevation myocardial infarction (STEMI) undergoing successful Primary PCI without complications
Based on New York Heart Association (NYHA) functional class I,II,III
Informed consent for participation in study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure of primary PCI
Empagliflozin contraindications
Valvular heart disease with moderate and higher severity
Patients who need hemodynamic support during hospitalization
Not willing to continue participation in study
Receiving drugs ,eg Non-steroidal anti-inflammatory drugs (NSAIDs) which can not be denied</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receiving Empagliflozin 10 mg 1 tablet daily. Made by Actover co.</i_keyword>
      <i_keyword>Control group: Receiving Placebo (cellulose micro crystal tablet). 1 tablet daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Myocardial reinfarction. Timepoint: During 40-day follow up. Method of measurement: According to symptoms and ECG findings.</prim_outcome>
      <prim_outcome>Stroke. Timepoint: During 40-day follow up. Method of measurement: According to symptoms and physical examinations.</prim_outcome>
      <prim_outcome>Cardiac mortality. Timepoint: During 40-day follow up. Method of measurement: Cardiac death according to AHA guideline determined as paroxysmal cardiac arrest with no respiratory and circulatory response.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ejection fraction. Timepoint: During 40-day follow up. Method of measurement: By echocardiography.</sec_outcome>
      <sec_outcome>Systolic heart failure. Timepoint: During 40-day follow up. Method of measurement: By echocardiography.</sec_outcome>
      <sec_outcome>Re admission. Timepoint: During 40-day follow up. Method of measurement: Documented records.</sec_outcome>
      <sec_outcome>Angina. Timepoint: During 40-day follow up. Method of measurement: History.</sec_outcome>
      <sec_outcome>Second revascularization. Timepoint: During 40-day follow up. Method of measurement: Based on symptoms ECG and echocardiographic findings.</sec_outcome>
      <sec_outcome>Empagliflozin complications. Timepoint: During 40-day follow up. Method of measurement: Based on history, symptoms and echocardiography findings.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-17</approval_date>
        <contact_name>Research Ethics Committees of Guilan University of Medical Sciences</contact_name>
        <contact_address>Namjoo Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
