Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
256 participants
INTERVENTIONAL
2025-01-20
2026-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment
Dapagliflozin 10mg daily X 7 days
Dapagliflozin 10mg Tab
Dapagliflozin 10 mg daily X 7 days
CMR
CMR 3-5 days post randomization
Placebo
Placebo daily X 7 days
CMR
CMR 3-5 days post randomization
Interventions
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Dapagliflozin 10mg Tab
Dapagliflozin 10 mg daily X 7 days
CMR
CMR 3-5 days post randomization
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Principal Investigators
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Michel LeMay, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Michel Le May
Role: primary
Other Identifiers
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20230332-01H
Identifier Type: -
Identifier Source: org_study_id
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