Comparative study of the lipids effects of telmisartan and valsartan in patients with STEMI

To help determine the more effective drug between telmisartan and valsartan in the acute phase of STEMI, in order to select a more standardized and guideline-based treatment to improve patient

This study is a single-center, parallel-group, active-controlled randomized clinical trial in 248 patients with acute ST-segment elevation myocardial infarction. Eligible patients will be randomly assigned one-to-one to receive telmisartan or valsartan. Randomization will be performed using a simple randomization list generated by the computer software Random.org,

This study is a single-center randomized clinical trial conducted at Bu-Ali-Sina Teaching and Therapeutic Hospital in Qazvin. Eligible patients with acute myocardial infarction with ST-segment elevation will be enrolled after confirming the diagnosis based on clinical criteria, electrocardiography, and cardiac enzymes, and after obtaining written informed consent. .

Inclusion criteria: Patients aged 30 to 80 years with acute ST-segment elevation myocardial infarction (STEMI) based on clinical criteria, electrocardiography, and cardiac enzymes Indications for the use of renin-angiotensin system inhibitors (ACE inhibitors or angiotensin receptor blockers) .... Exclusion criteria Myocardial infarction with cardiogenic shock or symptomatic heart failure ...

Intervention group 1 (Telmisartan) . Active control group (Valsartan)

Changes in lipid profile including total cholesterol, LDL-C, HDL-C, and triglycerides; changes in metabolic markers related to blood sugar including FBS and HbA1c; changes in left ventricular function based on ejection fraction (LVEF)

This study was an open-label randomized clinical trial

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.

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.

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.

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.

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.

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.