<?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>IRCT20220515054855N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-05</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Colchicine on the Prevention of Atrial Fibrillation after Coronary Artery Bypass Grafting Surgery(CABG)</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Colchicine on the prevention of Atrial Fibrillation after Coronary Artery Bypass Grafting surgery(CABG); a Clinical Trial Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>230</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63672</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random block method using rendomizer software, Blinding description: Patients in the first Group will be given 0.5 mg of Colchicine every 12 hours for 48 hours before surgery, and 0.5 mg daily if they weigh less than 70 kg until discharge. Patients in the second Group will be given a Placebo similar to the conditions in the first group. Therapists and Evaluators will not be informed of the assignment of Individuals to study Groups, and the type of medication prescribed. Setting for assigning Individuals to Study Groups will be with the Project Epidemiologist.</study_design>
      <phase>3</phase>
      <hc_freetext>Atrial Fibrillation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group will be given orally 0.5 mg of colchicine every 12 hours 48 hours before surgery, and 0.5 mg daily until discharge if they weigh less than 70 kg. The patients will be monitored during hospitalization and if any  Atrial fibrillation or its absence and the duration of hospitalization are recorded in the patient's checklist. Intervention 2: Control group: Patients in the control group will be given a placebo similar to the conditions of the intervention group.  Patients are monitored during hospitalization, and if atrial fibrillation occurs or not, and the duration of hospitalization is recorded in the patient checklist.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can be shared

When:
after publishement

To whom:
every one

Conditions:
without roules

Where to obtain:
Publisher Magazine Website

How to obtain:
search

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Babak Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh zahra Hospital., Municipality Squar., Artesh blvd., Sari Town</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818813371</zip>
        <telephone>+98 11 48 33323023</telephone>
        <email>bbagheri@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Babak Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh Zahra Hospital., Municipality Square., Artesh blvd., Sari Town</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818813371</zip>
        <telephone>0098 11 3323023</telephone>
        <email>bbagheri@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with coronary artery disease who are candidates for coronary artery bypass graft surgery.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I00-I99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>بیماری های قلب و عروق</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 the intervention group will be given orally 0.5 mg of colchicine every 12 hours 48 hours before surgery, and 0.5 mg daily until discharge if they weigh less than 70 kg. The patients will be monitored during hospitalization and if any  Atrial fibrillation or its absence and the duration of hospitalization are recorded in the patient's checklist.</i_keyword>
      <i_keyword>Control group: Patients in the control group will be given a placebo similar to the conditions of the intervention group.  Patients are monitored during hospitalization, and if atrial fibrillation occurs or not, and the duration of hospitalization is recorded in the patient checklist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Atrial fibrilation. Timepoint: Monitoring until discharge. Method of measurement: monitiring in icu.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: From CABG surgery to hospital discharge. Method of measurement: monitoring.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-24</approval_date>
        <contact_name>Ethics Committee Of Mazandaran University Of Medical Sciences</contact_name>
        <contact_address>Municipality Square., Army Blvd., Next To The Blood Transfusion Organization Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
