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IRCT20191109045384N1 IRCT 2020-03-11 Tabriz University of Medical Sciences Effects of atorvastatin and rosuvastatin on prevention of atrial fibrillation Comparison of effects of atorvastatin and rosuvastatin in the prevention of atrial fibrillation in patients undergoing coronary artery bypass graft 2019-02-20 anticipated 200 Complete https://irct.ir/trial/43542 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be selected in two intervention (100 patients) and control (100 patients) groups. in this method with considering sample size, two colored cards (red and blue) with the equal quantity and the total sample size will be placed in a container. Then the qualified participants randomly will take one of the cards from the container and finally they will be entered in the atorvastatin or rosuvastatin groups, Blinding description: For blinding the study, drug given in two groups will be unlabeled, in which both drugs will be completely similar in color and form, and patients will not be aware of their medication. Also, during the hospitalization of the patient care, staffs and the person which will report the atrial fibrillation with Holter Monitoring won,t know about the patient's receiving drug and the patient's study group. 2 Atrial fibrillation post coronary artery bypass graft. Intervention 1: Intervention group: Administration of rosuvastatin (chemical formula (C22H27FN3O6S)2Ca) 20 mg / day (manufactured by Atiya Pharmaceutical New Technologies (FNDA)) one week before coronary artery bypass graft surgery in patients undergoing elective bypass surgery. Continuing of administration the drug until discharge and Holter monitoring during the first 72 hours after coronary artery bypass surgery (in the ICU ward) and taking daily ECG during admission in cardiology ward for up to one month and observation of changes. Intervention 2: Control group:Administration of atorvastatin (chemical formula (C33H35FN2O5) 40 mg / day (manufactured by Atiya Pharmaceutical New Technologies (FNDA)) one week before coronary artery bypass graft surgery in patients undergoing elective bypass surgery. Continuing of administration the drug until discharge and Holter monitoring during the first 72 hours after coronary artery bypass surgery (in the ICU ward) and taking daily ECG during admission in cardiology ward for up to one month and observation of changes. 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 the trial has not completed
public Zahra Samadifar
No27,10th 8meters Block, Daneshgah Alley, Attar Neishabouri Street
Tabriz Iran (Islamic Republic of) 5165938667 +98 41 3544 8657 dr.zahra2011@gmail.com Tabriz University of Medical Sciences scientific Zahra Samadifar
No27,10th 8meters Block, Daneshgah Alley, Attar Neishabouri Street
Tabriz Iran (Islamic Republic of) 5165938667 +98 41 3544 8657 dr.zahra2011@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The preoperative EKG of the patient must have sinus rhythm For the study, the patient must have satisfaction The patient must be a candidate for elective surgery The CABG surgery of the patient should be on pump 30 years no limit Both Urgent CABG surgery Previous cardiac surgery Cardiac surgery except CABG Left ventricular ejection fraction less than or equal to 25% Diameter of left atrium more than 6 cm in echocardiography Need to inotropic agents after surgery Being dependent on pace maker after surgery The patient's rhythm shouldn't be sinus. Hyperthyroidism Aortic and mitral valves disorder more than moderate Renal failure I48.0 Paroxysmal atrial fibrillation Prevention Prevention Intervention group: Administration of rosuvastatin (chemical formula (C22H27FN3O6S)2Ca) 20 mg / day (manufactured by Atiya Pharmaceutical New Technologies (FNDA)) one week before coronary artery bypass graft surgery in patients undergoing elective bypass surgery. Continuing of administration the drug until discharge and Holter monitoring during the first 72 hours after coronary artery bypass surgery (in the ICU ward) and taking daily ECG during admission in cardiology ward for up to one month and observation of changes. Control group:Administration of atorvastatin (chemical formula (C33H35FN2O5) 40 mg / day (manufactured by Atiya Pharmaceutical New Technologies (FNDA)) one week before coronary artery bypass graft surgery in patients undergoing elective bypass surgery. Continuing of administration the drug until discharge and Holter monitoring during the first 72 hours after coronary artery bypass surgery (in the ICU ward) and taking daily ECG during admission in cardiology ward for up to one month and observation of changes. Incidence rate of atrial fibrillation post coronary artery bypass graft. Timepoint: Holter monitoring for 72 hours and daily ECG for one week and if it continues after one week, daily ECG will be taken until discharge.(up to 1 month). Method of measurement: Holter momitor and ECG devices. Incidence of diabetes and myopathy as possible complications of rosuvastatin. Timepoint: Fasting blood glucose and creatine phosphokinase measurement and clinical examination at the end of the first week and then at the end of the first month and then six months later. Method of measurement: Clinical examination and testing of fasting blood glucose and creatine phosphokinase. Tabriz University of Medical Sciences Approved 2020-01-07 Ethics committee of Tbariz University of Medical Scinces No. 27, Eighth of ten meters alley, University alley street, Attar neishabouri street Tabriz East Azarbaijan Iran (Islamic Republic of)