Recruiting
Phase 3

SGLT2i

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT06174753

Conditions

ST Elevation Myocardial Infarction

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dapagliflozin 10mg Tab

CMR

Study Details

Brief 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.

Conditions

ST Elevation Myocardial Infarction

Myocardial Infarction

Study ID

NCT06174753

Start date

Jan 20, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Dapagliflozin 10mg daily X 7 days

placebo comparator: Placebo

Placebo daily X 7 days

Interventions

Dapagliflozin 10mg Tab

Dapagliflozin 10 mg daily X 7 days

CMR

CMR 3-5 days post randomization

Primary outcome measure

  • Infarct Size [ Time Frame: 3-5 days ]

Central Contacts and Locations

Central contacts

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-02-20.