Dapagliflozin 10mg Tab: Dapagliflozin 10 mg daily X 7 days
CMR: CMR 3-5 days post randomization
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Infarct Size — 3-5 days Infarct size (% of total LV mass) measured by CMR
Trial sites (1)
Facility
City
Region
Status
University of Ottawa Heart Institute
Ottawa
Ontario
Recruiting
More Ottawa Heart Institute Research Corporation trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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