<?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>IRCT201105126463N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-06</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of early tirofiban adminstration in emergency department on TIMI flow 3</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of early bolus dose of tirofiban in emergency department on early TIMI flow 3 of the patients with myocardial infarction undergoing primary PCI</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6899</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization, Blinding description: Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Are blinded by coding to the subjects.</study_design>
      <phase>3</phase>
      <hc_freetext>acute myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in  1-3 minutes as soon as possible in the emergency department. Intervention 2: The control group will not receive tirofiban in emergency department.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3964438/pdf/ircmj-16-9641.pdf</results_url_link>
      <results_summary>Effect of Early Treatment With Tirofiban on Initial TIMI Grade 3 Flow of Patients With ST Elevation Myocardial Infarction.
Salarifar M, Mousavi M, Yousefpour N, Nematipour E, Kassaian SE, Poorhosseini H, Hajizeinali A, Alidoosti M, Aghajani H, Nozari Y, Amirzadegan A, Bozorgi A, Genab Y.
Abstract
Background: Before primary percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction (STEMI), it is not clear whether a routine early administration of glycoprotein IIb/IIIa inhibitors in the emergency ward is beneficial or their administration in selected cases in the catheterization laboratory.
Objectives: The present randomized clinical trial sought to investigate whether an earlier administration of Tirofiban could exert any impact on TIMI grade 3 flows and ST resolution in the electrocardiography of patients with STEMI before primary PCI.
Materials and Methods: Patients with STEMI within twelve hours of symptom commencement were included if primary PCI was planned to be performed within ninety minutes of admission and excluded if they had contraindications for Tirofiban. Seventy patients were randomized to receive 25 μg/kg of bolus Tirofiban early in the emergency ward (the early Tirofiban group) in three minutes and 70 did not receive Tirofiban (the control group). The primary endpoint of the study was a Thrombolysis in Myocardial Infarction (TIMI) grade 3 flows on the initial angiogram. The study is registered as IRCT201105126463N1 in: www.irct.ir.
Results: The study population had a mean age of 57.17 ± 10.09 years and included 79.3 % males. TIMI grade 3 flow was seen in 15 (21.4 %) patients of the Tirofiban group and 7 (10 %) of the control group (P = 0.06, odds ratio = 0.407, and 95 % confidence interval = 0.155-1.072). Complete ST resolution was seen in 30 (42.9 %) patients of the Tirofiban group and 34 (48.6 %) of the control group (P = 0.5).
Conclusion: Although TIMI grade 3 flows trended to be higher in the patients who received early Tirofiban in the emergency ward, the difference did not constitute statistical significance and possible benefits, therefore, require further clarification.
Iran Red Cres Med J. 2014 January; 16(1): e9641.
DOI: 10.5812/ircmj.9641</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:
The article

When:
Mar 2018

To whom:
Anyone

Conditions:
No other documents

Where to obtain:
The corresponding author

How to obtain:
Email to corespounding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Seyed Hesameddin Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al Ahmad &amp; North Kargar cross</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713138</zip>
        <telephone>+98 21 8802 9702</telephone>
        <email>Abbasi.hesam@gmail.com</email>
        <affiliation>Tehran Heart Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mehdi Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al Ahmad &amp; North Kargar cross</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713138</zip>
        <telephone>+98 21 8802 9600</telephone>
        <email>mmoosavi@razi.tums.ac.ir</email>
        <affiliation>Tehran Heart Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Acute myocardial infarction patient with ST segment elevation or new left bundle branch block in 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria: Stroke or TIA within the past 30 days or any history of hemorrhagic stroke, well known intra cranial disease (neoplasm or aneurysm), any active bleeding or bleeding history in past 30 days, uncontrolled HTN at registry time (SBP&gt;180, DBP&gt;110), Major operation or trauma in recent 6 weeks, platlete count less than 100000 or bleeding conditions, Coagulation disorders (INR&gt;1.5), Severe hepatic failure, Administration of any fibrinolytic treatment 24 hours from randomization, Renal failure (Cr&gt;205mg/dl or GFR &lt;30), age more than 75 years old</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in  1-3 minutes as soon as possible in the emergency department.</i_keyword>
      <i_keyword>The control group will not receive tirofiban in emergency department.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Prevalence of TIMI 3 flow score in coronary angiography. Timepoint: in cath lab before PCI. Method of measurement: according to angiography report.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Major Cardiac Event. Timepoint: one year. Method of measurement: clinical follow up.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-01-03</approval_date>
        <contact_name>Tehran Heart Center Ethic committee</contact_name>
        <contact_address>Jalal Al Ahmad &amp; North Kargar cross Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
