Dapagliflozin in STEMI

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.

Inclusion criteria

Patients referred for PPCI meeting the following criteria are eligible for the study:

• Ischemic chest discomfort of ≥30 minutes duration, and
• Onset of chest pain ≤12 hours prior to entry into the study, and
• One of the following High-Risk criteria on a standard 12 lead ECG:

a. Anterior STEMI with ST-segment elevation ≥2mm (0.2 mV) in each of at least 2 contiguous precordial leads (V1-V6) b. Extensive non-anterior STEMI defined as ST-segment elevation of >1mm in two or more contiguous non-anterior leads accompanied by i. 8 or more leads with > 1 mm ST elevation or depression, or both; OR ii. Sum of ST- segment elevation >20mm

Exclusion criteria

• Age < 18 years
• Any contraindication to undergo CMR imaging
• Killip 4 (Cardiogenic shock on presentation)
• Therapy with SGLT2i within last 8 weeks
• Type 1 diabetes mellitus
• Pregnancy
• Nursing mother
• Unwilling to use appropriate forms of contraception, as applicable
• Chronic symptomatic HF with prior hospitalization for HF within the last year
• hospitalization
• Known history of prior MI
• Any non-CV condition with a life expectancy of less than one year
• Previous randomization in the present study
• Participation in a study with another investigational device or drug < four weeks
• Inability to provide informed consent
• Confirmed ketoacidosis at time of admission
• Known severe hepatic impairment (Cirrhosis)
• Severe renal impairment (eGFR < 30 mL/min1.73m2 (based on prior or baseline blood work)
• Known severe valvular heart disease
• Need for CABG within 90 days based on the results of the initial coronary angiogram
• False positive STEMI (based on the results of the coronary angiogram)