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IRCT20180113038329N1 IRCT 2018-05-01 Rasht University of Medical Sciences Effect of rosouvastatin in CABG Comparison the effect of preoperative high dose and low dose rosouvastatin therapy on clinical outcomes after coronary artery bypass graft (CABG) surgery 2018-04-03 anticipated 188 Complete https://irct.ir/trial/29938 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomly assigned to two groups of 94 people, using the Rand list software. The group A will receive rosouvastatin (Ropixon) 5 mg, the group B will receive rosouvastatin (Ropixon) 20 mg before surgery. Patients will be divided in two groups: A (low dose:5) and B (high dose:20), based on quadruple random blocks (block random allocation), Blinding description: This study is double blind, and the patient and researcher will be blinded, the researcher will not know the dose of the patient's medication. The patient will not be aware of the dose of rosouvastatin. The individuals who are selected as followers during the hospitalization and one month after surgery will be blind. A cardiologist who is not included in the study will done the follow-up of patients without knowing the dose of rosouvastatin. 4 Atrial fibrillation. Intervention 1: Intervention group 1: rosuvastatin tablet 5 mg once a day, starting at least two days before the coronary artery bypass surgery (CABG) and continuing until one month later. Intervention 2: Intervention group 2: rosuvastatin tablet 2‌0 mg once a day, starting at least two days before the CABG and continuing until one month later. Yes - There is a plan to make this available What will be shared: Information on the primary and secondary consequences When: 6 to 12 months after printing results To whom: Researchers working in scientific and academic institutions Conditions: Information on the main and secondary outcomes and the method of implementation and analysis and the results after approval by the scientific authority Where to obtain: m_sheikhi@gums.ac.ir How to obtain: 6 to 12 months after the publication of the results and also after examination by the scientific authority Comments:
public Sheikhi Mahdieh
Dr. Heshmat Hospital, Bayani St.,Valiasr Square
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 9064 gums.icrc@gmail.com Rasht University of Medical Sciences scientific Gholipoor Mahboobeh
Doctor Heshmat hospital, Bayani alley, Moslla Square
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 9064 gums.icrc@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients undergoing elective CABG surgery 18 years no limit Both Patients with atrial fibrillation (AF) rhythm The current liver disease (illness) including liver Cirrhosis, blood transaminase increment by 3 or more, Blood bilirubin concentration greater than 3 mg / dl Recent use of antifungal medicines (azoles of CYP3A4 inhibitors), Protease inhibitor, Macrolides, Cyclosporine History of myocardial infarction Renal transplantation history Renal insufficiency (serum creatinine> 2.5 mg/dl) Cardiogenic shock Pregnancy Patients with complications during CABG surgery and after that (such as need for surgery for any reason, hemodynamic disorders, long intubation, rhythm disorders, need for shock, need for pericardiocentesis or chest tubing) I48.0 Paroxysmal atrial fibrillation Treatment - Drugs Treatment - Drugs Intervention group 1: rosuvastatin tablet 5 mg once a day, starting at least two days before the coronary artery bypass surgery (CABG) and continuing until one month later. Intervention group 2: rosuvastatin tablet 2‌0 mg once a day, starting at least two days before the CABG and continuing until one month later. Atrial fibrillation. Timepoint: During the hospitalization period after coronary artery bypass graft surgery and one month later. Method of measurement: Cardiac monitoring, electrocardiogram. Hospitalization period. Timepoint: Duration of admission after coronary artery bypass graft surgery. Method of measurement: Number of admission days after coronary artery bypass graft surgery. Mortality. Timepoint: During the hospitalization period after coronary artery bypass graft surgery and one month later. Method of measurement: Registration of death in the case during hospitalization after coronary artery bypass graft surgery and post-clearance follow up to one month. The incidence of myocardial infarction. Timepoint: During the hospitalization period after coronary artery bypass graft surgery until thirty days after that. Method of measurement: Electrocardiogram (ECG),serum cardiac enzymes level by biochemical method. Changes of Ejection Fraction (EF). Timepoint: Before performing coronary bypass graft surgery and thirty days after that. Method of measurement: Determine the percentage of Ejection Fraction (EF) by echocardiography. High sensitivity C - ­Reactive Protein (hs_CRP) level. Timepoint: Before coronary artery bypass graft surgery and three days later. Method of measurement: Blood test, serum high sensitivity C - ­Reactive Protein (hs_CRP) level by Immunoturbidometry. Acute renal failure. Timepoint: Two days after coronary artery bypass graft surgery. Method of measurement: blood test, serum creatinine level by biochemical method. Stroke. Timepoint: Duration of hospitalization after coronary artery bypass graft surgery. Method of measurement: Based on patient's clinical symptoms and signs. Total cholesterol changes. Timepoint: Before the coronary artery bypass graft surgery and thirty days after that. Method of measurement: blood test, serum total cholesterol level by biochemical method. Triglyceride changes. Timepoint: Before the coronary artery bypass graft surgery and thirty days after that. Method of measurement: blood test, serum triglyceride levels by biochemical method. Low Density Lipoprotein (LDL) cholesterol changes. Timepoint: Before the coronary artery bypass graft surgery and thirty days after that. Method of measurement: blood test, serum Low Density Lipoprotein (LDL) cholesterol levels by biochemical method. High Density Lipoprotein (HDL) Cholesterol changes. Timepoint: Before the coronary artery bypass graft surgery and thirty days after that. Method of measurement: blood test, serum High Density Lipoprotein (HDL) Cholesterol levels by biochemical method. Dr. Abidi Pharmacy Company Rasht University of Medical Sciences Dr. Abidi Pharmacy Company Approved 2017-12-16 Ethics committee of Guilan University of Medical Sciences Research and Technology Deputy, Shahi‌‌‌d‌ Siyadati Ave., Namjoo Street Rasht Guilan Iran (Islamic Republic of)