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

Efficacy of dapagliflozin in preventing contrast associated acute kidney injury (CA-AKI) in patients with acute coronary syndrome (ACS) undergoing coronary angiography Effects of dapagliflozin on reducing renal replacement therapy in patients with ACS undergoing coronary angiography

‏This is a Phase III prospective, multicenter, randomized, double-blind, placebo-controlled, clinical trial evaluating the efficacy of dapagliflozin for the prevention of CA-AKI.The study will use parallel assignment intervention model, with randomization in a 1:1 ratio to receive either dapagliflozin or a matched placebo in addition to standard care. ‏

The study will be conducted at Rajaie hospital and Tehran Heart Center. Both patients and study personnel will be blinded by using matching placebo. Patients will be assigned to one of the intervention groups and will receive it until discharge after the confirmation of diagnosis in the emergency department.

‏Inclusion Criteria: ‏Patients over 18 years old hospitalized with ACS and candidates for coronary angiography or angioplasty ‏Signed informed consent to participate in the study ‏ ‏Exclusion Criteria: ‏Diabetes Type 1 ‏Patients treated with SGLT2 inhibitor ‏Creatinine clearance <25 ml/min ‏Severe liver disease Hypersensitivity to dapagliflozin Patient's non-consent History of recurrent urinary tract infections History of ketoacidosis pregnancy or lactation ‏ ‏

‏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. ‏

‏Primary Outcome ‏ The incidence of acute kidney injury according to the KDIGO criteria ‏Secondary Outcomes Need for renal replacement therapy ‏Length of hospital stay ‏ ‏

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.

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.

The final results of this study (not individual participant's data) will be published after the end of the study.

After the end of patient recruitment and data analysis

To principle investigator of other studies

The principle investigator of other studies should send their request to the principle investigator of the current study to be evaluated

From the principle investigator hessamkakavand@yahoo.com

After the requesting a reasonable request to the principle investigator, the data will be sent after one month.