NCT05852704 SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 800 participants in total. It began in 2024-04-04 with a primary completion date of 2027-12-04.

Brief Summary

The goal of this randomized, double-blinded, controlled clinical trial is to investigate if treatment with an sodium-glucose cotransporter-2 inhibitor (SGLT2) during the unique time window before coronary artery bypass surgery (CABG), can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury in patients with chronic coronary syndrome. The main questions it aims to answer are: * Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of new onset atrial fibrillation compared to placebo? * Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of acute kidney injury before hospital discharge compared to placebo? Participants will be administered dapagliflozin 10 mg once daily or placebo for a minimum of seven days while awaiting scheduled CABG and up until discharge, with a short interruption for surgery. The active arm will be compared to the placebo arm to see if dapagliflozin can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury.

Eligibility Criteria

Inclusion Criteria: * Written informed consent. * Patients aged 18 years or older. * Chronic coronary syndrome scheduled for elective isolated CABG surgery with extra corporeal circulation, or elective CABG surgery with extra corporeal circulation combined with aortic valve replacement, mitral valve surgery, and / or aortic root surgery. Exclusion Criteria: * Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment. * Intolerance, hypersensitivity, or other contraindications of dapagliflozin. * Type 1 diabetes mellitus. * Symptomatic hypotension or systolic blood pressure \<95 mmHg at two out of three measurements at enrolment. * Current acute decompensated heart failure or hospitalization due to decompensated heart failure \<4 weeks prior to enrolment. * Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy. * Implantation or intent to implant a cardiac resynchronization device within 12 weeks prior to enrolment. * Stroke or transient ischemic attack within 12 weeks prior to enrolment. * Symptomatic bradycardia or second or third-degree atrioventricular block without pacemaker treatment. * Any condition such as, but not limited to, malignancy, with a life expectancy of \<2 years based on the investigator's clinical judgement. * Hepatic impairment (aspartate transaminase or alanine transaminase \>3 × the upper limit of normal, or total bilirubin \>2 × upper limit of normal at the time of enrolment). * Severe (estimated glomerular filtration rate \< 25 mL/min/1.73 m2), unstable, or rapidly progressing renal disease at the time of enrolment. * CABG surgery planned within one week. * Emergency surgery with hemodynamic instability. * Previous history of AF. * Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile\*) 1. Who are not willing to use a highly effective method of contraception\*\* judged by the investigator, from the time of signing the informed consent throughout the trial and 4 weeks thereafter, OR 2. Who have a positive pregnancy test at enrolment or randomization, OR 3. Who are breast-feeding. * Participation or recent participation in a clinical trial with an investigational medicinal product within 30 days before randomization. * Previous randomization in the STENOTYPE trial. * Previous (within 30 days) or concomitant participation in another clinical trial with an investigational product. Registries and observational studies are allowed. * Mental inability, reluctance, or language difficulties of the subject, in the opinion of the investigator, that result in difficulty in understanding the meaning of participation in the trial.

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