Dapagliflozin in STEMI (DAPA STEMI)

February 18, 2026 updated by: Ottawa Heart Institute Research Corporation

The University of Ottawa Dapagliflozin in STEMI Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:
          • Michel Le May

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Dapagliflozin 10mg daily X 7 days
Drug: Dapagliflozin 10mg Tab
Dapagliflozin 10 mg daily X 7 days
Diagnostic test: CMR
CMR 3-5 days post randomization
Placebo Comparator: Placebo
Placebo daily X 7 days
Diagnostic test: CMR
CMR 3-5 days post randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct Size
Time Frame: 3-5 days
Infarct size (% of total LV mass) measured by CMR
3-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Multiple Cardiac Adverse Events (MACE)
Time Frame: 3 months, and 6 months
A composite of death, reinfarction, stroke, or rehospitalization for HF
3 months, and 6 months
Number of participants with Cardiogenic Shock
Time Frame: during initial hospitalization (*up to 30 days)
Evaluated using the SCAI classification; only class C, D, or E will be adjudicated as a secondary outcome
during initial hospitalization (*up to 30 days)
Number of Participants with Acute Kidney Injury
Time Frame: 3 months, and 6 months
As defined according to the KDIGO definition
3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Michel LeMay, MD, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230332-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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