Actively Recruiting
The University of Ottawa Dapagliflozin in STEMI Randomized Clinical Trial
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-02-20
256
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of dapagliflozin, a type of SGLT2 inhibitor, in reducing the size of heart damage in patients who have experienced a ST Elevation Myocardial Infarction (STEMI) and are undergoing primary percutaneous coronary intervention (PPCI). This randomized, double-blind, phase 3 clinical trial compares dapagliflozin with a placebo to better understand its impact on heart tissue after a heart attack. Participants will be randomly assigned to receive either dapagliflozin 10 mg or a placebo once daily for 7 days. Cardiac Magnetic Resonance (CMR) imaging will be performed 3 to 5 days after treatment begins to measure the size of the heart injury. Follow-up visits will occur at 30, 90, and 180 days to monitor cardiovascular events and other health outcomes. During the study, participants will undergo CMR scans, regular cardiovascular assessments, and safety monitoring, including checks for kidney function and heart complications. Researchers will track the size of the infarct and record any serious cardiac events, cardiogenic shock during hospitalization, and acute kidney injury. The total participation time includes the initial 7-day treatment period and follow-ups extending up to 6 months.
CONDITIONS
Brief Title
Dapagliflozin in STEMI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients referred for primary percutaneous coronary intervention (PPCI)
- Ischemic chest discomfort lasting 30 minutes or more
- Chest pain onset within 12 hours before study entry
- High-risk ST Elevation Myocardial Infarction (STEMI) diagnosed by ECG, including anterior STEMI with specific ST-segment elevation or extensive non-anterior STEMI with defined ECG criteria
- Age 18 years or older
You will not qualify if you...
- Age under 18 years
- Contraindications to Cardiovascular Magnetic Resonance (CMR) imaging
- Cardiogenic shock on presentation (Killip 4)
- SGLT2 inhibitor therapy within the last 8 weeks
- Type 1 diabetes mellitus
- Pregnancy or nursing mother
- Unwillingness to use contraception if applicable
- Chronic symptomatic heart failure with hospitalization in the past year
- Known history of prior myocardial infarction
- Life expectancy less than one year due to non-cardiovascular conditions
- Previous participation in this study
- Participation in another investigational drug or device study within four weeks
- Inability to provide informed consent
- Confirmed ketoacidosis at admission
- Severe liver impairment (cirrhosis)
- Severe kidney impairment (eGFR less than 30 mL/min/1.73 m2)
- Severe valvular heart disease
- Need for coronary artery bypass grafting (CABG) within 90 days
- False positive STEMI based on coronary angiogram results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants take dapagliflozin or placebo daily for 7 days following PPCI.
Daily dosing for 7 days
Duration - 1 day between day 3 and 5 after randomization
Participants undergo a cardiovascular magnetic resonance (CMR) imaging to assess infarct size.
1 visit (in-person)
Duration - Up to 180 days
Participants have follow-up visits to assess cardiovascular events and safety outcomes.
3 visits at 30, 90, and 180 days (in-person)
Trial Site Locations
Total: 1 location
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
Research Team
P
Poppy MacPhee, BScN
T
Tanya Abarbanel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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