Dapagliflozin in STEMI
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
About this trial
The goal of this clinical trial is to assess the safety and efficacy of SGLT2i in limiting infarct size in patients with STEMI referred for PPCI.
Eligible STEMI patients enrolled into the trial will be randomized to a SGLT2i or placebo.
Cardiovascular Magnetic Resonance (CMR) imaging will be used to determine the infarct size.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ischemic chest discomfort of ≥30 minutes duration, and
Onset of chest pain ≤12 hours prior to entry into the study, and
Disqualifiers
Age < 18 years
Any contraindication to undergo CMR imaging
Killip 4 (Cardiogenic shock on presentation)
Therapy with SGLT2i within last 8 weeks
Trial design
Design model
Parallel
Treatments tested in this trial
Dapagliflozin 10mg Tab
DrugDapagliflozin 10 mg daily X 7 days
CMR
Diagnostic testCMR 3-5 days post randomization
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Infarct Size
Infarct size (% of total LV mass) measured by CMR
Time frame
3-5 daysSecondary outcomes
1
Incidence of Multiple Cardiac Adverse Events (MACE)
A composite of death, reinfarction, stroke, or rehospitalization for HF
Time frame
3 months, and 6 months2
Number of participants with Cardiogenic Shock
Evaluated using the SCAI classification; only class C, D, or E will be adjudicated as a secondary outcome
Time frame
during initial hospitalization (*up to 30 days)3
Number of Participants with Acute Kidney Injury
As defined according to the KDIGO definition
Time frame
3 months, and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov