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IRCT20181026041471N1 IRCT 2024-08-20 Rajaie Cardiovascular Medical and Research Institute The efficacy of dapagliflozin in preventing contrast-associated acute kidney injury DARIUS Evaluating the effect of dapagliflozin on preventing contrast-associated acute kidney injury in patients with acute coronary syndrome undergoing angiography (DARIUS); a multicenter, randomized, double-blind, placebo-controlled clinical trial 2024-08-22 anticipated 1500 Complete https://irct.ir/trial/78089 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomized individually and via an online computer program to one of intervention or control groups after meeting the eligibility criteria. The randomization system will use block randomization method and the patients will be placed in the intervention or control group in a ratio of 1:1 by the online computer system in blocks of four, and each patient will receive a randomization code and the drug will be provided based on this code. The randomization sheet and the codes assigned to the patients will be designed by a statistician outside the current study, and the researcher will only see the code specified to the patient and will provide the medicine to the ward according to the code. These codes will be broken after the end of the study or based on the data and safety monitoring board (DSMB)'s demand, Blinding description: to perform blinding in this study, a matching placebo will be used. The patient's medication will be provided to the department based on the code assigned to the patient in the randomization system and placed in the corresponding patient's medication box, and when the patient is transferred to other departments, his medication will also be delivered to the destination department. None of the researchers, patients and the person who analyzes the final data will know which group the patient is in. The study's DSMB committee will have permission to break the treatment code at any time during the study. Also, during the study, after 25, 50 and 75% of the patients were recruited, the available data were analyzed by the DSMB committee, and this committee can stop the study if there is an increase in complications and harm to the patients. 3 Acute Coronary Syndrome. Intervention 1: Patients in the intervention group will receive 20 mg of dapagliflozin immediately after randomization and before entering the cath lab, followed by 10 mg daily for a minimum of 48 hours and up to 7 days. Intervention 2: Control group: Patients in this group will receive matching placebo (2 tablets before intervention) and then once daily for at least 48 hours and maximum 7 days. Yes - There is a plan to make this available What will be shared: The final results of this study (not individual participant's data) will be published after the end of the study. When: After the end of patient recruitment and data analysis To whom: To principle investigator of other studies Conditions: The principle investigator of other studies should send their request to the principle investigator of the current study to be evaluated Where to obtain: From the principle investigator hessamkakavand@yahoo.com How to obtain: After the requesting a reasonable request to the principle investigator, the data will be sent after one month. Comments:
public Hessam kakavand
Rajaie Cardiovascular Medical and Research Institute, Niayesh Junction, Valiasr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 hessamkakavand@yahoo.com Iran University of Medical Sciences scientific Hessam kakavand
Rajaie Cardiovascular Medical and Research Institute, Niayesh Junction, Next to Mellat Park, Valiasr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 hessamkakavand@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients over 18 years old hospitalized with acute coronary syndrome (i.e. ST elevation or NST elevation myocardial infarction or unstable angina) diagnosis and candidates for coronary angiography or angioplasty Signed informed consent to participate in the study 18 years no limit Both Patients previously treated with SGLT2 inhibitor drugs Creatinine clearance less than 25 ml/min Chronic liver disease and cirrhosis (Child-Pugh C) Drug allergy or history of severe hypersensitivity to dapagliflozin or its components Non-consent to participate in the study History of recurrent urinary tract infections History of ketoacidosis Pregnancy or breastfeeding Type 1 diabetes mellitus I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Prevention Placebo Patients in the intervention group will receive 20 mg of dapagliflozin immediately after randomization and before entering the cath lab, followed by 10 mg daily for a minimum of 48 hours and up to 7 days. Control group: Patients in this group will receive matching placebo (2 tablets before intervention) and then once daily for at least 48 hours and maximum 7 days ‏The incidence of contrast- associated acute kidney injury defined by KDIGO criteria . Timepoint: 7 days after intervention. Method of measurement: Lab findings (serum creatinine) and urine output. Need for renal replacement therapy. Timepoint: 7 days‏ after intervention. Method of measurement: Clinical records. Length of hospitalization. Timepoint: Until discharge from hospital. Method of measurement: Clinical records. Incidence of adverse drug reactions. Timepoint: 7 days after randomization. Method of measurement: Clinical records. Tehran University of Medical Sciences Rajaie Cardiovascular Medical and Research Institute Tehran University of Medical Sciences Approved 2024-05-21 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qods Ave. and Keshavarz Blvd. junction, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)