<?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>IRCT2014062916229N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-24</date_registration>
      <primary_sponsor>Vice chancellor for research,, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The impact of Allopurinol in acute myocardial infarction</public_title>
      <acronym></acronym>
      <scientific_title>The impact of allopurinol versus placebo in patients with acute ST elevation myocardial infarction undergoing fibrinolytic therapy with streptokinase</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>146</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15258</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The trial is double blind, so neither the patients nor the investigator are aware of the type of administered drug (Allopurinol or placebo). Random drug list has been prepared by the governing board of the Center for Drug Research.</study_design>
      <phase>3</phase>
      <hc_freetext>myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: patients will receive four oral Allopurinol 100mg tablets when arriving at the emergency department, followed by one 100mg tablet daily for 4 weeks. &#13;
Allopurinol is a xanthine oxidase inhibitor and decreases production of uric acid. Intervention 2: Intervention 2: Placebo tablets are similar in appearance with Allopurinol tablets,which patients will receive four oral tablets when arriving at the emergency department, followed by one tablet daily orally for 4 weeks.&#13;
Allopurinol and Placebo tablets has prepared by Drug Applied Research Center of Tabriz University of Medical Sciences.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samad Ghaffari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiovascular Research Center, Daneshgah St., Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166615573</zip>
        <telephone>+98 41 3337 3819</telephone>
        <email>ghafaris@gmail.com</email>
        <affiliation>Cardiovascular Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samad Ghaffari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiovascular Research Center, Daneshgah St., Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166615573</zip>
        <telephone>+98 41 3335 7770</telephone>
        <email>ghafaris@gmail.com</email>
        <affiliation>Cardiovascular Research Center of Tabriz University of Medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with first acute STEMI who are candidates for fibrinolytic therapy&#13;
Exclusion criteria: Patients with firs acute STEMI who are candidates for Primary PCI, Patients with previous myocardial infarction or Primary valvular disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>121.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute transmural myocardial infarction of unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: patients will receive four oral Allopurinol 100mg tablets when arriving at the emergency department, followed by one 100mg tablet daily for 4 weeks. &#13;
Allopurinol is a xanthine oxidase inhibitor and decreases production of uric acid.</i_keyword>
      <i_keyword>Intervention 2: Placebo tablets are similar in appearance with Allopurinol tablets,which patients will receive four oral tablets when arriving at the emergency department, followed by one tablet daily orally for 4 weeks.&#13;
Allopurinol and Placebo tablets has prepared by Drug Applied Research Center of Tabriz University of Medical Sciences.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ST resolution (in milimeter). Timepoint: On arriving at the emergency department (before the intervention) and 90 minute after streptokinase adminsteration(intervention) in emergency department. Method of measurement: ECG.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cardiac biomarkers level. Timepoint: first 48 hour (arrival at the emergency department (before the intervention) and then daily(after the intervention)). Method of measurement: laboratory.</sec_outcome>
      <sec_outcome>Heart failure. Timepoint: During hospitalization. Method of measurement: Physical examination and history and echocardiography.</sec_outcome>
      <sec_outcome>Recurrent myocardial infarction. Timepoint: six month after intrvention (streptokinase). Method of measurement: Telephone follow-up and patients hospital records.</sec_outcome>
      <sec_outcome>In hospital death. Timepoint: During hospitalization. Method of measurement: Physical examination.</sec_outcome>
      <sec_outcome>Six month death. Timepoint: six month after intrvention (streptokinase). Method of measurement: Telephone follow-up and patients hospital records.</sec_outcome>
      <sec_outcome>Re-hospitalization for acute decompensation of heart failure. Timepoint: six month after intrvention (streptokinase). Method of measurement: Telephone follow-up and patients hospital records.</sec_outcome>
      <sec_outcome>Repeat revascularization. Timepoint: six month after intrvention (streptokinase). Method of measurement: Telephone follow-up and patients hospital records.</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>Vice chancellor for research,, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-22</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Daneshgah St., Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
