<?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>IRCT20190903044682N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-26</date_registration>
      <primary_sponsor>Neyshabour University of Medical Sciences</primary_sponsor>
      <public_title>statin and inflamation</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Atorvastatin versus Rosuvastatin on level of inflammatory markers and low density lipoprotein-cholesterol (LDL) in Patients with acute coronary syndrome: double blind randomize control trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41924</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects with inclusion criteria were randomly divided into two groups: atrostatin and rosuvastatin. For this purpose, we randomly divide the participants into atrostatin and simvastatin groups using 4-way randomized blockade. In this study, we will prepare four leaves that are typed on the two leaves of the letter A (atrostatin) and on the other two leaves of the letter R (rosuvastatin) and draw one card for each patient, without the card being drawn. Insert. At the end of each block we have an equal number of people who received treatment A or treatment R. This process continues until the patient has been included in the study as a sample size, Blinding description: In this study, atrovstatin and rosuvastatin are poured into similar envelopes by a secretary and then coded, envelopes are coded, patients are assigned an envelope in order of study, and the envelope code is recorded for each patient. Participants, all researchers, other cardiologists, CCU nurses and cardiologists, laboratory staff, data collectors, patients with phone calls for follow-up, and the Committee on Safety and Data Monitoring, and The person drafting the article is not aware of the contents of the envelopesatment received and face blindness.</study_design>
      <phase>3</phase>
      <hc_freetext>Levels of inflammatory markers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: atrovastetin is a drug manufactured by Abidi Pharmaceutical Company at a dose of 80 mg once daily after dinner for 60 days. Intervention 2: Intervention group: Rosvastatin is a drug manufactured by Abidi Pharmaceutical Company at a dose of 40 mg once daily after dinner for 60 days.</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>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Samaneh Tabaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Between Farhang 2&amp;4, , Farahbakhsh gharbi, Neyshabour</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>93191169111</zip>
        <telephone>0985142255524</telephone>
        <email>tabaees@nums.ac.ir</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Samaneh Tabaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Between Farhang 2&amp;4, , Farahbakhsh gharbi, Neyshabour</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9319116911</zip>
        <telephone>+98 51 4225 5524</telephone>
        <email>tabaees@nums.ac.ir</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Acute coronary syndrome based on clinical signs and ECG and serum markers</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>renal failure
Liver failure
Immunosuppressants, corticosteroids or potent inhibitors of cytochrome P450 3A4, pentoxifylline, silostazole, glucosamine, berberine barberry extract
Having underlying inflammatory or infectious diseases
Left Schiff's Leukostosis
TG&gt;400
CHF with NYHA III or IV
Having a history of diseases that cause malabsorption syndromes
Uncontrolled blood pressure
Evidence of endocrine or metabolic disease affecting lipid profile</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>موضوع مطالعه یک بیماری نیست</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: atrovastetin is a drug manufactured by Abidi Pharmaceutical Company at a dose of 80 mg once daily after dinner for 60 days.</i_keyword>
      <i_keyword>Intervention group: Rosvastatin is a drug manufactured by Abidi Pharmaceutical Company at a dose of 40 mg once daily after dinner for 60 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood levels of inflammatory markers. Timepoint: Before starting the study and 60 days later beginning. Method of measurement: Laboratory measurement by ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lipid profile. Timepoint: Before the intervention and at the end of the intervention. Method of measurement: Laboratory measurement with Pars test kit with Autoanalyzer bt 3000.</sec_outcome>
      <sec_outcome>Blood levels of inflammatory markers. Timepoint: Before the intervention and at the end of the intervention. Method of measurement: Laboratory 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>Neyshabour University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-09</approval_date>
        <contact_name>Ethics committee of Neyshabour University of Medical Sciences</contact_name>
        <contact_address>University Pardis, Shen Shui Street, Neyshabur Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
