Using dapagliflozin to reduce heart damage in STEMI patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of dapagliflozin, an SGLT2 inhibitor, in minimizing heart damage in patients experiencing ST Elevation Myocardial Infarction (STEMI) who are undergoing primary percutaneous coronary intervention (PPCI). Eligible participants will be randomly assigned to receive either dapagliflozin or a placebo for seven days. Cardiovascular Magnetic Resonance (CMR) imaging will be utilized to measure the size of the heart infarct at days 3-5, with follow-up visits scheduled at 30, 90, and 180 days to monitor cardiovascular events.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Ottawa Heart Institute
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Michel LeMay, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Poppy MacPhee, BScN
• Email: pmacphee@ottawaheart.ca
• Phone: 6136967000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.