<?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>IRCT20220813055675N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-16</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Ticagrelor on the Clinical consequences of Angioplasty in Myocardial Infarction and Covid-19.d</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effects of Ticagrelor on the Prognosis of Percutaneous Coronary Interventions in Patients with Covid-19 and Comparing it with Clopidogrel</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65269</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization method is used by Excel software, and by Random function in this software. The randomization unit in this method will be individual. Patients are divided into two groups: Ticagrelor and Clopidogrel, Blinding description: In this study, the researcher, who is also responsible for the follow-up of patients and the evaluation of the expected outcomes, and finally analyzes the data with the cooperation of statisticians, will be unaware of the type of medicine prescribed for the groups throughout the study. The desired drugs will be prescribed to the patients by the residents, or doctors who coordinate with the research team in the emergency room.</study_design>
      <phase>3</phase>
      <hc_freetext>Myocardial Infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Ticagrelor drug ("Brilavus" from ABIDI Company) is prescribed orally at the loading dose of 180 mg at the beginning of the patient's visit and before the start of angioplasty, then will be given at the dose of 90 mg every 12 hours as a daily dose. Other prescription drugs are similar to the control group and are performed according to the guidelines. Intervention 2: Control group: Clopidogrel drug ("Plavix" from Sanofi Company) is prescribed orally at the dose of 600 mg at the beginning of the patient's visit and before the start of angioplasty, then will be given at the dose of 75 mg every 24 hours as a daily dose. Other prescription drugs are similar to the intervention group and are performed according to the guidelines.</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 collected data can be published.

When:
Access starts 3 months after the results are published.

To whom:
All people.

Conditions:
Any type of data and analysis is accessible. For this purpose, please call 09125752404.

Where to obtain:
Dr Reza Arefi Zadeh, 501 AJA hospital

How to obtain:
It is necessary to go to 501 Aja Hospital, cardiology department, or call 09125752404. E-mail: saeedtofighi69@gmail.com is also available for respected clients.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Arefi Zade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Etemad Zadeh St., West Fatemi Ave., 501 Aja Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718546</zip>
        <telephone>+98 21 8609 6350</telephone>
        <email>arefizadehreza@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Tofighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 30, Parcham St, Tohid Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1457874993</zip>
        <telephone>+98 31 5544 8236</telephone>
        <email>saeedtofighi69@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 18 years of age who present with acute myocardial infarction.
Candidates for emergent coronary angioplasty ( Percutaneous coronary intervention )
Less than 24 hours have passed since the onset of chest pain symptoms.
are infected with the concomitant covid-19 disease (proved by CT Scan or PCR).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of patient consent to perform coronary interventions or enter the study
Chronic and necessary use of any anti-coagulant drug by the patient
severe renal failure (GFR less than 30)
Severe heart failure (EF less than 30%)
Age under 18 years old
Pregnancy or suspected pregnancy
History of intracranial or intraspinal bleeding
Administration of any intravenous antiviral drug in the same admision
Severe liver failure
Past history of any malignancy or chemotherapy regimen</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Ticagrelor drug ("Brilavus" from ABIDI Company) is prescribed orally at the loading dose of 180 mg at the beginning of the patient's visit and before the start of angioplasty, then will be given at the dose of 90 mg every 12 hours as a daily dose. Other prescription drugs are similar to the control group and are performed according to the guidelines.</i_keyword>
      <i_keyword>Control group: Clopidogrel drug ("Plavix" from Sanofi Company) is prescribed orally at the dose of 600 mg at the beginning of the patient's visit and before the start of angioplasty, then will be given at the dose of 75 mg every 24 hours as a daily dose. Other prescription drugs are similar to the intervention group and are performed according to the guidelines.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiovascular Death. Timepoint: During the index admission, and after 1 month from hospital discharge. Method of measurement: Admission file and follow-up data.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stent Thrombosis. Timepoint: During index admission and 1 month after discharge. Method of measurement: Coronary Angiography.</sec_outcome>
      <sec_outcome>Myocardial Infarction. Timepoint: During index admission and 1 month after discharge. Method of measurement: Troponin measurement and Electrocardiography.</sec_outcome>
      <sec_outcome>Arterial O2 saturation. Timepoint: During the index admission. Method of measurement: Pulse-Oxymetry.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-11</approval_date>
        <contact_name>Ethics committee of AJA University of Medical Sciences</contact_name>
        <contact_address>Etemad Zade St., West Fatemi Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
