<?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>IRCT2017082117756N24</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-10</date_registration>
      <primary_sponsor>Vice-chancellery of Research, Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Effects of tissue plasminogen activator and dual antiplatelet therapy in acute ischemic stroke treatment</public_title>
      <acronym>-</acronym>
      <scientific_title>A comparative study of the effects of tissue plasminogen activator and dual antiplatelet therapy on improvement of the score of the National Institutes of Health Stroke Scale in acute ischemic stroke treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16264</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a double-blind study and both the physician and the patient are unaware of the study groups. Moreover, the participants will be selected via convenience sampling method and assigned into intervention and control groups via randomized blocked allocation method (i.e., 1:1).</study_design>
      <phase>2</phase>
      <hc_freetext>acute ischemic stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group (tissue plasminogen activator ): The cases receive tissue plasminogen activator (Retavase®) 0.9 milligram per kilogram (maximum doses: 90 milligram) where 10 percent of the total dose is administered as a 10 U bolus dose followed by a 60-minute infusion of the remaining doses. Clinical response will be assessed at the initial presentation, after 24 and 48 hours, and at discharge from hospital by national institutes of health stroke scale. Decrease in score of national institutes of health stroke scale will be considered as the sign of improvement. Intervention 2: Control Group (dual antiplatelet therapy): The controls receive dual antiplatelet therapy by daily aspirin 80 milligram and clopidogrel 75 milligram for three months. After three months, the clopidogrel will be discontinued. Clinical response will be assessed at the first presentation, after 24 and 48 hours and at discharge from hospital by national institutes of health stroke scale. Decrease in score of national institutes of health stroke scale will be considered as the sign of improvement.</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>Dr. Elham Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.,</address>
        <city>Birjand,</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3222 5402</telephone>
        <email>dr.elizarei@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hamidreza Riasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neurology Ward, Valiasr Hospital, Ghaffari St.,</address>
        <city>Birjand,</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3242 5402</telephone>
        <email>riasi_h@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Proved ischemic stroke; informed consent for participation; stroke symptoms initiated within 4.5 hours before admission; no brain hemorrhage on initial computerized tomography scan; clinical national institutes of health stroke scale between 4 and 18. &#13;
Exclusion criteria: Age 80 years or above; brain hemorrhage in initial computerized tomography scan; history of stroke; history of diabetes mellitus; patients currently receiving oral anticoagulant treatment without considering the international normalized ratio; clinical national institutes of health stroke scale above 25; large  ischemic changes of brain or involvement of more than one-third of middle cerebral artery supplying zone in the initial computerized tomography scan.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>cerebrovascular (embolic) (ischemic) (thrombotic)</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 Group (tissue plasminogen activator ): The cases receive tissue plasminogen activator (Retavase®) 0.9 milligram per kilogram (maximum doses: 90 milligram) where 10 percent of the total dose is administered as a 10 U bolus dose followed by a 60-minute infusion of the remaining doses. Clinical response will be assessed at the initial presentation, after 24 and 48 hours, and at discharge from hospital by national institutes of health stroke scale. Decrease in score of national institutes of health stroke scale will be considered as the sign of improvement.</i_keyword>
      <i_keyword>Control Group (dual antiplatelet therapy): The controls receive dual antiplatelet therapy by daily aspirin 80 milligram and clopidogrel 75 milligram for three months. After three months, the clopidogrel will be discontinued. Clinical response will be assessed at the first presentation, after 24 and 48 hours and at discharge from hospital by national institutes of health stroke scale. Decrease in score of national institutes of health stroke scale will be considered as the sign of improvement.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>National Institutes of Health Stroke Scale score. Timepoint: at the initial presentation, after 24 and 48 hours, and at discharge from hospital. Method of measurement: Physical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications of tissue plasminogen activator treatment. Timepoint: after 24 and 48 hours from the initiation of treatment and at discharge from hospital. Method of measurement: brain computerized tomography scan.</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-chancellery of Research, Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-18</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Vice-chancellery of Research, Birjand University of Medical Sciences, Ghaffari St., Birjand,  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
