<?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>IRCT20170925036401N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-07</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>effect of eptifibatide and reteplase on primary angioplasty outcomes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of intracoronary and intravenous Eptifibatide and intracoronary Retaplase on coronary blood flow in patients undergoing PPCI at Dr.Heshmat hospital during 2017-2018 (Randomized clinical trial study)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27756</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: random block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute Myocardial Infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1: Patients who have a stent after thrombosuction. Intervention 2: Intervention group:Group 2: Patients who receive 180 microgram per kilogram of intracoronary bolus eptifibatide by interval of 10 minutes and then stent is embeded. Intervention 3: Intervention group:Group 3: Patients who receive 6 mg of intra-coronary reptal after thrombosis, and then inserted into the stent. Intervention 4: Intervention group: Group 4:Patients after thrombosuction will receive 180 microgram per kilogram of intravenous bolus eptifibatide and then receive 2 microgram per kilogram per minute of infusion over 18 hours.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa Zadkamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>the old building of the School of Public Health,opposite the 17th Shahrivar Hospital,, Namjoo Ave, Shahid Siadati Ave,Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41446-66949</zip>
        <telephone>+98 13 3333 6394</telephone>
        <email>mzadkamali@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Zadkamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to Gilan Province Management and Planning Organization, 15 khordad Ave, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55588</zip>
        <telephone>+98 13 3366 9064</telephone>
        <email>mzadkamali@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ischemic tipic chest pain extending more than 30 min, STelevation more than 1 mm in at least 2 leads with the same name,                                                                                                   all patients with STEMI candidate for primary PCI,            myocardial infarction not extending more than 12 hours,       having life expectancy not less than 6 months,                      consent for participation in the study, age 18 to 80 years,             no evidence for prior myocardial infarction,                                  not having contraindications for reteplase or eptifibatide,            not having left bundle branch block,                                               not using GPIIb/IIIa in recent two weeks.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>rescue PCI after thrombolytic therapy,                               emergency CABG,                                                                   cardiogenic shock,                                                                               atrial fibrillation                                                                                                                                                                                  TIMI flow grade 3 in primary angiography(ie, having normal blood flow in coronary arteries)                                                                         simultaneously presence in another intervention study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>121</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group 1: Patients who have a stent after thrombosuction.</i_keyword>
      <i_keyword>Intervention group:Group 2: Patients who receive 180 microgram per kilogram of intracoronary bolus eptifibatide by interval of 10 minutes and then stent is embeded.</i_keyword>
      <i_keyword>Intervention group:Group 3: Patients who receive 6 mg of intra-coronary reptal after thrombosis, and then inserted into the stent.</i_keyword>
      <i_keyword>Intervention group: Group 4:Patients after thrombosuction will receive 180 microgram per kilogram of intravenous bolus eptifibatide and then receive 2 microgram per kilogram per minute of infusion over 18 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coronary blood flow. Timepoint: before and after primary PCI. Method of measurement: based on angiographic scale TIMI blush grade.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Left ventricular diastolic dysfunction change. Timepoint: before and after angiography. Method of measurement: according to echocardiographic criteria.</sec_outcome>
      <sec_outcome>ST resolution average. Timepoint: before and 90 minutes after PCI. Method of measurement: based on electrocardiogram.</sec_outcome>
      <sec_outcome>Average of EF changes. Timepoint: before and 3 to 4 days after angioplasty. Method of measurement: based on echocardiography.</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>2017-11-04</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>the old building of the School of Public Health ,opposite the 17th Shahrivar Hospital, Shahid Siadati Ave,Namjoo Ave ,Rasht Town Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
