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IRCT20120215009014N407 IRCT 2021-11-18 Hamedan University of Medical Sciences Effect of Coenzyme Q10 as an adjunct therapy versus placebo on para-clinical signs after primary angioplasty of coronary artery in acute ST-elevation myocardial infarction Effect of Coenzyme Q10 as an adjunct therapy versus placebo on para-clinical signs after primary angioplasty of coronary artery in acute ST-elevation myocardial infarction: a double-blind randomized clinical trial 2021-12-06 anticipated 70 Complete https://irct.ir/trial/60026 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The medication and placebo will be injected having perfectly the same shape. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 3 ST elevation myocardial infarction. Intervention 1: Intervention group: Routine treatment plus injection of Coenzyme Q10 400 mg (manufactured by Dana pharmaceutical Co.) immediately after angioplasty and then 200 mg every 12 hours for 28 days. Intervention 2: Control group: Routine treatment plus injection of placebo (normal saline) 4 ml immediately after angioplasty and then 2 ml every 12 hours for 28 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Kimia Shirmohammadi
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 kimiashirmohamadi99@gamil.com Hamedan University of Medical Sciences scientific Dr. Maryam Mehrpooya
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 m_mehrpooya2003@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 80 years; Myocardial ischemia for at least 30 minutes; Myocardial infarction disease in the last 12 hours; Elevated ST segment on electrocardiogram; Angioplasty for the first time; 18 years 80 years Both Candidate for emergency coronary bypass surgery; History of heart attack or heart failure or angioplasty; Indication for thrombolytic therapy; Cardiogenic shock; Liver failure; Autoimmune diseases or inflammation; Taking antioxidant medicines in the past month; I21.0 ST elevation (STEMI) myocardial infarction of anterior wall Treatment - Drugs Placebo Intervention group: Routine treatment plus injection of Coenzyme Q10 400 mg (manufactured by Dana pharmaceutical Co.) immediately after angioplasty and then 200 mg every 12 hours for 28 days Control group: Routine treatment plus injection of placebo (normal saline) 4 ml immediately after angioplasty and then 2 ml every 12 hours for 28 days The serum level of troponin. Timepoint: Before angioplasty and 6, 12, 24, 48, and 72 hours after that. Method of measurement: By laboratory test. The serum level of CK-MB. Timepoint: Before angioplasty and 6, 12, 24, 48, and 72 hours after that. Method of measurement: By laboratory test. Thrombolysis in myocardial infarction (TIMI) flow grade. Timepoint: After angioplasty. Method of measurement: By laboratory test. Myocardial blushing grade (MBG). Timepoint: After angioplasty. Method of measurement: By echocardiography. ST-segment resolution. Timepoint: Immediately and 24 hours after angioplasty. Method of measurement: By echocardiography. Left ventricular ejection fraction. Timepoint: 30 days after angioplasty. Method of measurement: By echocardiography. Adverse effects (heart failure, cardiogenic shock, re-infarction, and death). Timepoint: during the treatment period. Method of measurement: with taking history. Hamedan University of Medical Sciences Approved 2021-10-31 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)