<?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>IRCT20171028037047N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-22</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of ezetimibe and atorvastatin treatment versus atorvastatin alone on Major Adverse Cardiac Events</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of ezetimibe and atorvastatin treatment versus atorvastatin alone on Major Adverse Cardiac Events (MACE) after elective  percutaneous coronary intervention (PCI)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>224</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28808</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In randomized manner, every patient who goes to PCI will be included in the study if they have all the inclusion criteria and no exclusion ones. Then by tossing coin they will be randomly divided into intervention and non intervention groups, Blinding description: Patients in the first group receive atorvastatin 40 mg and ezetimibe 10 mg daily. In the second group, the placebo is given in the same dose as in the original package, with the same shape, color and size, and in a manner that is not differentiated from the original drug. Medications will be packaged in pre-prepared packages to patients so that patients and people who record the results of the study will be unaware of how the patients will be grouped.</study_design>
      <phase>4</phase>
      <hc_freetext>Myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group receive atorvastatin 40 mg and ezetimibe 10 mg daily. Intervention 2: Control group: Patients in this group receive atorvastatin 40 mg and placebo 10 mg daily. The placebo is given in the same dose as in the original package, with the same shape, color and size, and in a manner, that is not differentiated from the original drug.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahin Abbas Zadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Chamran Blvd.</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916613885</zip>
        <telephone>+98 76 3333 7379</telephone>
        <email>sh-abaszadeh@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahin Abbas Zadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Chamran Blvd.</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916613885</zip>
        <telephone>+98 76 3333 7379</telephone>
        <email>sh-abaszadeh@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are candidates for elective PCI
Having normal hepatic enzymes
Having negative troponin
Having LDL values greater than 100 mg / dL</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having Inflammatory and rheumatologic diseases
Having Infectious diseases
Having malignancies
Having high creatinine levels
Having abnormal liver enzymes
Pregnancy and lactation
Use of NSAIDs
Patient's dissatisfaction with participating in the study
Having ejection fraction below 30 (EF &lt; 30)
Having myocardial infarction in the last month
The increase in troponin after PCI more than 5 times higher than normal maximum of 99 percentile</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in this group receive atorvastatin 40 mg and ezetimibe 10 mg daily</i_keyword>
      <i_keyword>Control group: Patients in this group receive atorvastatin 40 mg and placebo 10 mg daily. The placebo is given in the same dose as in the original package, with the same shape, color and size, and in a manner, that is not differentiated from the original drug</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Myocardial infarction. Timepoint: At intervals of 24 hours after PCI and one month after PCI. Method of measurement: ECG, hospital records, blood tests and imaging.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Unstable angina. Timepoint: At intervals of 24 hours after PCI and one month after PCI. Method of measurement: ECG, hospital records, blood tests and imaging.</sec_outcome>
      <sec_outcome>Death rate due to heart disease. Timepoint: At intervals of 24 hours after PCI and one month after PCI. Method of measurement: Hospital records.</sec_outcome>
      <sec_outcome>Stroke rate. Timepoint: At intervals of 24 hours after PCI and one month after PCI. Method of measurement: ECG, hospital records, blood tests and imaging.</sec_outcome>
      <sec_outcome>Stent thrombosis. Timepoint: At intervals of 24 hours after PCI and one month after PCI. Method of measurement: ECG, hospital records, blood tests and imaging.</sec_outcome>
      <sec_outcome>CRP value. Timepoint: At intervals of 24 hours after PCI and one month after PCI. Method of measurement: Blood tests.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-06</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Shahid Chamran Blvd. Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
