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IRCT20210710051833N1 IRCT 2022-06-22 Zanjan University of Medical Sciences Study the effect of Empagliflozin in type 2 diabetic patients To Study the effect of Empagliflozin on the Incidence of short-term major Cardiovascular events in type 2 diabetic patients with myocardial infarction requiring primary angioplasty 2022-07-23 anticipated 200 Complete https://irct.ir/trial/61316 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: This study will be performed as a double blind clinical trial. In such a way that neither the researcher nor the patient knows which group will be treated with the drug or placebo, and the drug and the placebo will be provided to the patients by coding a third party (co-planner). 3 Condition 1: Diabetes. Condition 2: Heart disease. Intervention 1: Intervention group Diabetic patients who presented with myocardial infarction and received 10 mg daily ampagliflozin tablets for three months. Intervention 2: Control group: Diabetic patients who presented with a heart attack and received a placebo daily for three months. Yes - There is a plan to make this available What will be shared: Study data including (personal information, test results and outcomes) will be available in encrypted form in special forms designed to follow patients. When: The beginning of the data access period will be after the publication of the results in April 1402. To whom: Documentation will be available to researchers working in academic and scientific institutions. Access to data will be possible for people working in industry by fully introducing and clarifying the purpose of use. Conditions: The use of data will be allowed only with the full introduction of researchers and clarification of the purposes of using the data and for use in future scientific issues and research. Where to obtain: To access the data, you can contact Dr. Zahra Kalantari's researcher via e-mail Zahra_kalantari88@yahoo.com and work address (Zanjan, Gavazang Boulevard, Mousavi Hospital). How to obtain: جهت دسترسی به داده ها پس از تماس با محقق از طریق ایمیا یا نشانی، پس از معرفی کامل فرد درخواست کننده و بیان هدف استفاده از داده ها، در طول مدت کمتر از یک ماه امکان دسترسی به داده ها وجود خواهد داشت. Comments:
public Zahra Kalantari
No. 18 , Azadegan Ave, Ahmadlo Blvd.
Zanjan Iran (Islamic Republic of) 4513753111 +98 24 3552 5654 Zahra_kalantari88@yahoo.com Zanjan University of Medical Sciences scientific Zahra Kalantari
No. 18 , Azadegan Ave., Ahmadlo Blvd.
Zanjan Iran (Islamic Republic of) 4513753111 +98 24 3552 5654 Zahra_kalantari88@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetic patients (treated with oral hypoglycemic drugs) with STEMI (typical chest pain lasting more than 30 minutes during the 12 hours prior to admission, with ST-segment elevation above 0.1 mV in both Lead or more on ECG) who will be admitted to Ayatollah Mousavi Hospital in Zanjan between August and October 1401 Diabetic patients with MI who have previously received prior treatment with metformin, sulfonylureas, or a combination of these two drugs. no limit no limit Both Cardiogenic shock Hypoglycemia Diabetic ketoacidosis History of coronary artery bypass surgery Type 1 diabetes Severe liver failure Patients with advanced cancer History of severe hypersensitivity to empagliflozin or its components Severe renal failure (eGFR <30 mL / minute / 1.73 m2), end-stage renal disease (ESRD) or dialysis Hypovolemia Any inflammatory disease being treated History of any cancer Advanced heart failure E11.69 Type 2 diabetes mellitus with other specified complication Treatment - Drugs Placebo Intervention group Diabetic patients who presented with myocardial infarction and received 10 mg daily ampagliflozin tablets for three months. Control group: Diabetic patients who presented with a heart attack and received a placebo daily for three months. Mortality associated with cardiovascular events. Timepoint: Hospitalization time and one month and three months later. Method of measurement: Monthly face-to-face visits, tests and echoes. Ventricular arrhythmia. Timepoint: Three months after hospitalization and intervention. Method of measurement: Review of patient's hospital records during three months. Re-infarction. Timepoint: Three months after hospitalization and intervention. Method of measurement: Review of patient's hospital records and echo. Need for cardiopulmonary resuscitation. Timepoint: Three months after hospitalization and intervention. Method of measurement: Review of patient's hospital records during three months. Congestive heart failure. Timepoint: Three months after hospitalization and intervention. Method of measurement: Review of patient's hospital records and echo. Requires revascularization of target vessels. Timepoint: Three months after hospitalization and intervention. Method of measurement: Review of patient's hospital records during three months. Stroke. Timepoint: Three months after hospitalization and intervention. Method of measurement: Review of patient's hospital records during three months. Cardiogenic shock. Timepoint: Three months after hospitalization and intervention. Method of measurement: Review of patient's hospital records during three months. Dr. Abidi Pharmaceutical Company Approved 2021-10-21 Ethics Committee of Zanjan University of Medical Sciences Azadi Blvd,Vice-Chancellor for Research and Technology Zanjan Zanjan Iran (Islamic Republic of)