<?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>IRCT20170925036401N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-22</date_registration>
      <primary_sponsor>Deputy of Research of Guilan 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 in thrombus aspiration in patients undergoing Primary percutaneous coronary interventions (PPCI); Randomized clinical trial study)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27220</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute Myocardial Infarction.</hc_freetext>
      <i_freetext>All patients will receive Emergency PCI treatment. Patients will receive 300 mg of chewing aspirin and 600 mg of Clopidogrel maintenance dose prior to the procedure before transferring to the catheterism room. In the first group, the patients undergo thrombus suction after the wiring , and then the stent is embedded.In the second group, the patients undergo thrombus suction after wiring , then receive 180μg / kg intra coronary bolus eptifibatide. Intra coronary eptifibatide will be injected 2 times with 10 minutes interval and then the stent will be embedded.In the third group, patients undergo thrombus suction after wiring , and then 6 mg intracoronary reteplase is injected and the stent will be embedded.In the fourth group, the patients undergo thrombus suction after wiring , then receive 180μg / kg intravenous bolus eptifibatide during 18 hours in the ward.After the procedure angiography report for TIMI blush grade and corrected TIMI frame count will be seen.All patients will be treated with a maintenance dose of 75 mg clopidogrel daily for one year and 300 mg of aspirin for 30 days and then 100 mg..</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>Mostafa Zadkamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht- parastar street- Headquarters building of Guilan University of Medical Sciences</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 3366 9064</telephone>
        <email>mzadkamali@gums.ac.ir/mhoseinie@yahoo.com/m_zadkamali@yahoo.com</email>
        <affiliation>Guilan University of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Zadkamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht, Namjoo Ave., Shahid Siadati Avenue, opposite the 17th Shahrivar Hospital, the old building of the School of Public Health</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 3333 6394</telephone>
        <email>mzadkamali@gums.ac.ir/ mhoseinie@yahoo.com  /m_zadkamali@yahoo.com</email>
        <affiliation>Deputy of Research of Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:
Ischemic typical chest pain extending more than 30 min;
ST elevation 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>Exclusion criteria: 
Rescue PCI after thrombolytic therapy;
emergency CABG;
AF;
cardiogenic shock;
TIMI flow grade 3 in primary angiography</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All patients will receive Emergency PCI treatment. Patients will receive 300 mg of chewing aspirin and 600 mg of Clopidogrel maintenance dose prior to the procedure before transferring to the catheterism room. In the first group, the patients undergo thrombus suction after the wiring , and then the stent is embedded.In the second group, the patients undergo thrombus suction after wiring , then receive 180μg / kg intra coronary bolus eptifibatide. Intra coronary eptifibatide will be injected 2 times with 10 minutes interval and then the stent will be embedded.In the third group, patients undergo thrombus suction after wiring , and then 6 mg intracoronary reteplase is injected and the stent will be embedded.In the fourth group, the patients undergo thrombus suction after wiring , then receive 180μg / kg intravenous bolus eptifibatide during 18 hours in the ward.After the procedure angiography report for TIMI blush grade and corrected TIMI frame count will be seen.All patients will be treated with a maintenance dose of 75 mg clopidogrel daily for one year and 300 mg of aspirin for 30 days and then 100 mg.</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>Deputy of Research of Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-04</approval_date>
        <contact_name>Deputy of Research of Guilan University of Medical Sciences</contact_name>
        <contact_address>Rasht, Namjoo Ave., Shahid Siadati Avenue, opposite the 17th Shahrivar Hospital, the old building of the School of Public Health Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
