Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT05852704
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05852704
Study Brief:
Protocol Section:
NCT05852704