<?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>IRCT201207303799N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences Vice chancellor for research</primary_sponsor>
      <public_title>Oral low dose Amiodarone  and prevention of atrial fibrillation</public_title>
      <acronym></acronym>
      <scientific_title>The effects of oral low dose amiodarone in prevention of atrial fibrillation after coronary artery bypass graft (A Placebo-Controlled Randomized Clinical Trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>170</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3917</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Coronary Artery Diseases.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group with systolic blood pressure above 80 mmgh and rate of more than 60/min, a total of 4.2 grams oral amiodarone is administered as: 600 mg, the night before surgery and also 600 mg, on the morning of surgery and then from the first day after operation followed by 200 mg every 8 hours for five days after surgery. Amiodarone is an antiarrhythmic drug used for various types of cardiac dysrhythmias, both ventricular and atrial. In this study, the oral form of amiodarone is used. Each tablet contains 200 mg amiodarone hydrochloride. This product is manufactured by Amin pharmaceutical company. Intervention 2: Patients in the control group receive placebo pills which are specifically designed to have no real effect. They are made of an inert substance. These tablets in terms of size, shape, packaging and name are exactly similar to the amiodarone tablets. Only the code written on the boxes are different from each other. Frequency and duration of using placebo pills in the control group are absolutely the same as amiodarone pills in the intervention group. This product is manufactured by Amin pharmaceutical company.</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>Nasim Shayan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiac Surgery and Transplantation Research Center, Dr. Shariati Hospital, North Karegar Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713137</zip>
        <telephone>+98 21 8863 3037</telephone>
        <email>ctrc@tums.ac.ir; nsm_shayan@yahoo.com</email>
        <affiliation>Cardiac Surgery and Transplantation Research Center of Dr. Shariati Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahmoodreza Sarzaeem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiac Surgery and Transplantation Research Center, Dr. Shariati Hospital, North Karegar Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713137</zip>
        <telephone>+98 21 8863 3037</telephone>
        <email>ctrc@tums.ac.ir; sarzaeem_mr@yahoo.com</email>
        <affiliation>Cardiac Surgery and Transplantation Research Center of Dr. Shariati Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with coronary artery disease (on angiography) who are candidate for coronary artery bypass. Exclusion criteria: 1- Patients above 80 years old. 2- Patients who have atrial fibrillation before surgery. 3- Patients with heart valve disease or arrhythmia or having every degree of heart block conduction. 4- Patients who use a pacemaker. 5- Patients who have chronic lung, liver or kidney disease. 6- Patients who have other heart surgeries simultaneously with bypass surgery. 7- Patients who are allergic to amiodarone or in any way giving amiodarone to them is contraindicated. 8- Having sick sinus syndrome.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group with systolic blood pressure above 80 mmgh and rate of more than 60/min, a total of 4.2 grams oral amiodarone is administered as: 600 mg, the night before surgery and also 600 mg, on the morning of surgery and then from the first day after operation followed by 200 mg every 8 hours for five days after surgery. Amiodarone is an antiarrhythmic drug used for various types of cardiac dysrhythmias, both ventricular and atrial. In this study, the oral form of amiodarone is used. Each tablet contains 200 mg amiodarone hydrochloride. This product is manufactured by Amin pharmaceutical company.</i_keyword>
      <i_keyword>Patients in the control group receive placebo pills which are specifically designed to have no real effect. They are made of an inert substance. These tablets in terms of size, shape, packaging and name are exactly similar to the amiodarone tablets. Only the code written on the boxes are different from each other. Frequency and duration of using placebo pills in the control group are absolutely the same as amiodarone pills in the intervention group. This product is manufactured by Amin pharmaceutical company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>AF rhythm. Timepoint: From the second day of the intervention and after CABG surgery, continuous monitoring for the first 72 hours and then daily ECG is done until discharge. Method of measurement: ECG recording device.</prim_outcome>
      <prim_outcome>Length of stay in ICU. Timepoint: At the time of transferring to the ward. Method of measurement: Refer to the data sheet in ICU.</prim_outcome>
      <prim_outcome>Duration of hospital stay. Timepoint: At discharge time. Method of measurement: Refer to the Patient file.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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 Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-06-09</approval_date>
        <contact_name>Research Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Central Organization of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
