ST Elevation Myocardial InfarctionPhase 3DAPA STEMINCT06174753
Dapagliflozin in STEMI
A Phase 3 study testing Dapagliflozin 10mg Tab and CMR in people with ST Elevation Myocardial Infarction and Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Myocardial Infarction
- What is being tested?
- Dapagliflozin 10mg Tab and CMR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Michel Le May
About this study
Official title: 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.
Read the 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.
- Being tested
- Dapagliflozin 10mg Tab, CMR
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Dapagliflozin 10 mg daily X 7 days
CMRDiagnostic test
CMR 3-5 days post randomization
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Dapagliflozin 10mg daily X 7 days Receives: Drug: Dapagliflozin 10mg Tab; Diagnostic Test: CMR |
| Placebo | Placebo comparator | Placebo daily X 7 days Receives: Diagnostic Test: CMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct Size
Infarct size (% of total LV mass) measured by CMR
Measured: 3-5 days
Secondary outcomes (3)
Incidence of Multiple Cardiac Adverse Events (MACE)
A composite of death, reinfarction, stroke, or rehospitalization for HF
Measured: 3 months, and 6 months
Number of participants with Cardiogenic Shock
Evaluated using the SCAI classification; only class C, D, or E will be adjudicated as a secondary outcome
Measured: during initial hospitalization (*up to 30 days)
Number of Participants with Acute Kidney Injury
As defined according to the KDIGO definition
Measured: 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start20 Jan 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a single center, randomized, double-blind, parallel group study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel LeMay, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174753
- Sponsor's protocol ID
- 20230332-01H
- Acronym
- DAPA STEMI
- Status last verified
- Feb 2026
- First submitted
- 7 Dec 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The University of Ottawa Dapagliflozin in STEMI Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06174753
- Acronym / sponsor ID
- DAPA STEMI / 20230332-01H
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- a single center, randomized, double-blind, parallel group study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Dapagliflozin 10mg Tab, Diagnostic Test: CMRDapagliflozin 10mg daily X 7 days |
| Placebo | Placebo comparator | Diagnostic Test: CMRPlacebo daily X 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg TabDapagliflozin 10 mg daily X 7 days | Drug | Treatment |
| CMRCMR 3-5 days post randomization | Diagnostic test | Placebo, Treatment |
Primary outcome
Infarct Size
Time frame: 3-5 days
Infarct size (% of total LV mass) measured by CMR
3 secondary outcomes
Incidence of Multiple Cardiac Adverse Events (MACE)
Time frame: 3 months, and 6 months
Number of participants with Cardiogenic Shock
Time frame: during initial hospitalization (*up to 30 days)
Number of Participants with Acute Kidney Injury
Time frame: 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michel LeMay, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10mg Tab and CMR in people with ST Elevation Myocardial Infarction and Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Poppy MacPhee, BScN (6136967000 ext. 14646, pmacphee@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct Size (time frame: 3-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.