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.
DAPA STEMI is a single center, randomized, double-blind, parallel group study in which eligible participants with a STEMI and undergoing PPCI will be recruited and randomly assigned to dapagliflozin or placebo to take for 7 days. Participants will be prescribed study treatment i.e. dapagliflozin (10 mg) or placebo daily for 7 days. A CMR will be obtained at day 3-5 to assess for infarct size. Participants will have follow-up visits at 30, 90, and 180 days to assess for cardiovascular events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
256
Dapagliflozin 10 mg daily X 7 days
CMR 3-5 days post randomization
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
RECRUITINGInfarct Size
Infarct size (% of total LV mass) measured by CMR
Time frame: 3-5 days
Incidence of Multiple Cardiac Adverse Events (MACE)
A composite of death, reinfarction, stroke, or rehospitalization for HF
Time frame: 3 months, and 6 months
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)
Number of Participants with Acute Kidney Injury
As defined according to the KDIGO definition
Time frame: 3 months, and 6 months
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