BridgeMD
SGLT2 inhibitor TrEatment iN patients awaiting cOronary arTery bYpass surgery to reduce Post-opErative atrial fibrillation and kidney injury (STENOTYPE trial).
EU CTIS ID: 2023-505375-75-00
What this study is testing
To establish the efficacy of dapagliflozin in reducing the incidence of new onset post-operative AF during hospitalization following CABG.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) The subject has given their written consent to participate in the trial.
- 2) Subject is ≥18 years at the time of written consent.
- 3) Chronic coronary syndrome documented by coronary angiography, scheduled for CABG surgery with extra corporeal circulation. OR Patients with chronic coronary syndrome scheduled for CABG surgery with extra corporeal circulation and aortic valve replacement with extra corporeal circulation. AND/OR Patients with chronic coronary syndrome scheduled for CABG surgery with extra corporeal circulation and mitral valve replacement or repair with extra corporeal circulation. AND/OR Patients with chronic coronary syndrome scheduled for CABG surgery with extra corporeal circulation and aortic root surgery with extra corporeal circulation.
You likely can't join if
- 1) Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment.
- 10) Any condition such as, but not limited to, malignancy, with a life expectancy of <2 years based on the investigator’s clinical judgement.
- 11) Known hepatic impairment.
- 12) Severe (estimated GFR < 25 mL/min/1.73 m2), unstable, or rapidly progressing renal disease at the time of enrolment.
- 13) CABG surgery planned within one week
- 14) Emergency surgery with hemodynamic instability.
See the full eligibility criteria
Who can join
- 1) The subject has given their written consent to participate in the trial.
- 2) Subject is ≥18 years at the time of written consent.
- 3) Chronic coronary syndrome documented by coronary angiography, scheduled for CABG surgery with extra corporeal circulation. OR Patients with chronic coronary syndrome scheduled for CABG surgery with extra corporeal circulation and aortic valve replacement with extra corporeal circulation. AND/OR Patients with chronic coronary syndrome scheduled for CABG surgery with extra corporeal circulation and mitral valve replacement or repair with extra corporeal circulation. AND/OR Patients with chronic coronary syndrome scheduled for CABG surgery with extra corporeal circulation and aortic root surgery with extra corporeal circulation.
What rules you out
- 1) Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment.
- 10) Any condition such as, but not limited to, malignancy, with a life expectancy of <2 years based on the investigator’s clinical judgement.
- 11) Known hepatic impairment.
- 12) Severe (estimated GFR < 25 mL/min/1.73 m2), unstable, or rapidly progressing renal disease at the time of enrolment.
- 13) CABG surgery planned within one week
- 14) Emergency surgery with hemodynamic instability.
- 15) Previous history of AF.
- 16) Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile*) a. 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 b. Who have a positive pregnancy test at enrolment or randomization, OR c. Who are breast-feeding.
- 17) Participation or recent participation in a clinical trial with an IMP within 30 days before randomization.
- 18) Previous randomization in the STENOTYPE trial.
- 19) Previous (within 30 days) or concomitant participation in another clinical trial with an investigational product. Registries and observational studies are allowed.
- 2) Intolerance, hypersensitivity, or other contraindications of dapagliflozin.
- 20) 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.
- 3) Type 1 diabetes mellitus.
- 4) Symptomatic hypotension or systolic blood pressure <95 mmHg at two out of three measurements at enrolment.
- 5) Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment.
- 6) Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy.
- 7) Implantation or intent to implant a cardiac resynchronization device within 12 weeks prior to enrolment.
- 8) Stroke or transient ischemic attack within 12 weeks prior to enrolment.
- 9) Symptomatic bradycardia or second or third-degree atrioventricular block without pacemaker treatment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.