BridgeMD
New treatment option for Chronic Coronary Syndrome
Official title SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF
ClinicalTrials.gov ID: NCT05852704
What this study is testing
What is Dapagliflozin 10mg Tab?
Dapagliflozin 10mg Tab is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic coronary syndrome.
Also referred to as Farxiga, Forxiga.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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\ )
- 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
- Who have a positive pregnancy test at enrolment or randomization, OR
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brno, Czechia
- Aarhus, Denmark
- Copenhagen, Denmark
- Odense, Denmark
- Gothenburg, Sweden
- Linköping, Sweden
- Lund, Sweden
- Örebro, Sweden
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brno, Czechia; Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark; Gothenburg, Sweden; Linköping, Sweden and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.