<?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>IRCT20251213068301N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-25</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Comparative study of the lipids effects of telmisartan and valsartan in patients with STEMI</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the lipids effects of telmisartan and valsartan in patients with STEMI</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>248</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/88066</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study was an open-label randomized clinical trial.</study_design>
      <phase>4</phase>
      <hc_freetext>Myocardial infarction (MI).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Telmisartan. Intervention 2: Intervention group: Valsartan.</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:
Document / Data Title
Deidentified Data of Patients with STEMI in the Telmisartan and Valsartan Comparison Trial
Document / Data Details
Participant personal data including baseline demographic information, baseline clinical characteristics, metabolic laboratory parameters (lipid profile and blood glucose indicators), and primary outcome variables of the study will be potentially shareable after all identifying and de-identifying information has been removed.
Data sharing will be limited to data related to the primary and secondary outcomes of the study, and raw patient identifying information (including name, national code, case number, or contact information) will not be provided at any stage.
Access to data will only be possible upon written request from researchers and after approval by the investigator responsible for the study.

When:
De-identified participant data will be available to eligible researchers for 6 months after the publication of the main study results and for 5 years.

To whom:
De-identified data of participants will be accessible to eligible researchers. These individuals include researchers working in academic and research institutions as well as independent researchers, provided that they submit a written request and their research purpose is approved by the investigator responsible for the study. Access to data for commercial or industrial purposes is not possible without the written consent of the investigator responsible for the study.

Conditions:
De-identified data and study documentation are authorized for use only for research and scientific analyses related to the metabolic effects of telmisartan and valsartan in patients with STEMI. Requests for access to data must be made in writing, stating the specific research purpose, and will be made available upon approval by the study investigator.
Use of data for commercial, promotional, or any non-scientific publication is prohibited. Applicant researchers are required to keep all data de-identified and confidential after use and to cite any publication of results to the original study.

Where to obtain:
All requests for access to de-identified data and study documentation should be sent to the study investigator:
Name and title: Dr. Majid Haji Karimi (principal investigator)
Center: Bu-Ali Sina Educational and Therapeutic Center, Qazvin, Iran
Postal address: Iran-Qazvin Province-Qazvin City-Bu-Ali St.-Bu-Ali Sina Educational and Therapeutic Center Qazvin
Email: majidhajikarimi57@gmail.com
Phone: 00982833332935
Fax: 00982833326033
Priority of response is as follows:
Send written request via email
Call or fax for further coordination
Send postal letter if necessary
Applicants are required to state their research objective and the type of analysis desired in the request. All requests will be authorized for scientific and research use after review and approval by the study investigator.

How to obtain:
Submitting a written request: The applicant must send an email or formal letter to the study investigator including the research objective, the type of analysis desired, and their contact information.
Reviewing the request: The study investigator reviews the request and ensures that the proposed use is consistent with the scientific objectives of the study and complies with the principles of research ethics.
Approval and conclusion of the agreement: If approved, the applicant is required to sign a confidentiality agreement and comply with the terms of use of data and documentation.
Data preparation: De-identified data and documentation limited to the primary and secondary outcomes are prepared.
Data delivery: Data is provided to the applicant via secure email, encrypted file, or secure download link.
⏱ Duration: The entire process from the time the request is submitted to the time the data is received usually takes about 4 to 6 weeks, depending on the volume of the request and the time it takes the study investigator to review it.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad taghi pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Boali hospital</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413786165</zip>
        <telephone>+98 28 3333 2930</telephone>
        <email>mohamad.taghipoor70@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad taghi pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Boali hospital</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413786165</zip>
        <telephone>+98 28 3333 2930</telephone>
        <email>mohamad.taghipoor70@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with STEMI
Abdicación clases 1 for ACE OR ARB</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) 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: Telmisartan</i_keyword>
      <i_keyword>Intervention group: Valsartan</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lipid profile including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides. Timepoint: 3 m after starting the medication. Method of measurement: Blood sampling and serum testing with a standard blood biochemistry analyzer.</prim_outcome>
      <prim_outcome>Serum creatinine level and glomerular filtration rate (GFR) indicating kidney function. Timepoint: Before starting the medication and 3 m  after starting the medication. Method of measurement: Blood sample and serum analysis with standard device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic and diastolic blood pressure of patients. Timepoint: Before starting the medication, 4 weeks after starting the medication. Method of measurement: Standard mercury sphygmomanometer.</sec_outcome>
      <sec_outcome>Body mass index (BMI) of patients. Timepoint: Before starting the medication, 4 weeks after starting the medication. Method of measurement: Measuring height and weight with a standard scale and tape measure.</sec_outcome>
      <sec_outcome>Fasting blood glucose level. Timepoint: Before starting the medication, 4 weeks after starting the medication. Method of measurement: Blood sample and serum test with standard blood biochemistry analyzer.</sec_outcome>
      <sec_outcome>Adverse drug reactions. Timepoint: During the treatment period. Method of measurement: Questionnaire and clinical interview.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-13</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>boali qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
