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IRCT20120215009014N414 IRCT 2021-12-29 Hamedan University of Medical Sciences Effect of coenzyme Q10 versus placebo on the prevention of contrast medium-induced nephropathy in patients undergoing primary angioplasty Effect of coenzyme Q10 versus placebo on the prevention of contrast medium-induced nephropathy in patients undergoing primary angioplasty: a double-blind randomized clinical trial 2021-12-25 anticipated 50 Complete https://irct.ir/trial/60435 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 shape of the medications and placebos will be perfectly the same. 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 Angioplasty. Intervention 1: Intervention group: Routine treatment (angiotensin inhibitors, statin, anti-placket, beta-blockers) plus one capsule Q10 400 mg (manufactured by Dana Pharmaceutical Co.) single dose immediately before angioplasty and then 200 mg every 12 hours for 3 days. Intervention 2: Control group: Routine treatment (angiotensin inhibitors, statin, anti-placket, beta-blockers) plus one capsule placebo as a single-dose immediately before angioplasty and then one capsule every 12 hours for 3 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 Ayesheh Rahmani
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 918 458 5937 ayshehr97@gmail.com Hamedan University of Medical Sciences scientific Dr. Davood Ahmadimoghdam
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 d.ahmadimoghdam@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 75 years; Symptoms of persistent myocardial ischemia for at least 30 minutes; Less than 12 hours after the onset of heart attack symptoms; Increased ST segment on electrocardiogram; Treated with primary angioplasty; 18 years 75 years Both Consumption of any antioxidants in the past month; Indication of cardiac bypass surgery; History of myocardial infarction or angioplasty; Indication of thrombolytic therapy; Cardiogenic shock; History of heart failure; Advanced liver failure or autoimmune or inflammatory diseases Z98.6 Angioplasty status Treatment - Drugs Placebo Intervention group: Routine treatment (angiotensin inhibitors, statin, anti-placket, beta-blockers) plus one capsule Q10 400 mg (manufactured by Dana Pharmaceutical Co.) single dose immediately before angioplasty and then 200 mg every 12 hours for 3 days Control group: Routine treatment (angiotensin inhibitors, statin, anti-placket, beta-blockers) plus one capsule placebo as a single-dose immediately before angioplasty and then one capsule every 12 hours for 3 days Nephropathy. Timepoint: Before the intervention and 24, 48, 72 hours after the intervention. Method of measurement: By measuring serum levels of BUN, creatinine and Estimated glomerular filtration rate (eGFR). Serum level of CRP. Timepoint: Before the intervention and 24, 48, 72 hours. Method of measurement: After the intervention by laboratory test. Hamedan University of Medical Sciences Approved 2021-11-29 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)