None listed
Conditions
Brief summary
Despite advancements in the management of acute myocardial infarction (AMI) including interventional and pharmacological treatments, the reoccurrence rate of coronary events post an AMI remains substantial. AMIs are caused by coronary artery disease (CAD), where there is an accumulation of lipid rich plaque in the coronary artery wall, which when ruptures causes thrombus formation and reduced coronary blood flow to the underlying myocardium. Sodium-glucose co-transporters 2 inhibitors (SGLT2is) are a glucose lowering medication which have been shown to have cardio-protective effects in type 2 diabetes, heart failure and chronic kidney disease. There is increasing evidence to suggest that SGLT2is may play a role in reducing atherosclerosis progression by decreasing inflammation and stabilise coronary plaque. The DECIPHER trial is a prospective, randomised, open label, blinded endpoint (PROBE) phase 4 clinical trial. It aims to assess the effects of 12 months of treatment with SGLT2i, Dapagliflozin on coronary plaque composition via computed tomography coronary angiogram (CTCA), coronary plaque inflammation via 18F -sodium fluoride (NaF) positron emission tomography (PET)/ magnetic resonance (MR) imaging, and myocardial remodelling via cardiac magnetic resonance (CMR) imaging in patients with an acute myocardial infarction. The DECIPHER trial aims to provide insight into the mechanistic action of SGLT2is in CAD and subsequent AMI.
Interventions
Participants in the intervention arm will receive dapagliflozin, 10mg once daily, as an oral tablet for the 12 month treatment period, in addition to standard of care including statin therapy and anti-platelet therapy.
Adherence to the intervention, dapagliflozin will be assessed by pill counting during follow up visits at 1 -, 6- and 12- months.
Sponsors
Victorian Heart Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients >/= 18 years 2. Admission to Victorian Heart Hospital or Victorian Heart Hospital Private with an acute myocardial infarction (MI) (ST-elevation MI or non-ST segment elevation of MI) 3. Culprit lesion identified on invasive coronary angiography (ICA) and successfully treated with percutaneous coronary intervention (PCI) 4. At least 1 non culprit lesion with 30-70% luminal stenosis in the epicardial vessel of >/= 2.5mm diameter identified on ICA and managed medically
Exclusion criteria
1. Prior myocardial infarction or coronary revascularisation 2. Coronary artery disease (CAD) requiring planned surgical revascularisation 3, Currently on treatment, or with an indication for treatment, with a sodium -glucose co-transporter 2 inhibitor (SGLT2i) (including type 2 diabetes mellitus, chronic kidney disease, and/or chronic heart failure) 4. Known intolerance or allergic/ anaphylactic reaction to SGLT2i 5. Severe renal impairment ( estimated glomerular filtration rate < 30ml/m/1.73m^2) 6. Severe hepatic impairment (Child-Pugh Class C) 7. Pregnant, or breast-feeding women of child bearing potential unable or unwilling to us effective birth control methods 8. Limited life expectancy (< 24 months) 9. Unwilling to undertake study procedures or adhere to study requirements 10. Unable to consent due to cognitive impairment or intellectual disability
Outcome results
None listed