NCT06174753RecruitingPhase 3
Dapagliflozin in STEMI
The University of Ottawa Dapagliflozin in STEMI Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 256 (estimated)
- First submitted
- 7 Dec 2023
- Start date
- 20 Jan 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Diseases
- Coronary artery disease
- NCT number
- NCT06174753
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 256
- From 20 Jan 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Therapy with SGLT2i within last 8 weeks
- Chronic symptomatic HF with prior hospitalization for HF within the last year
- Known history of prior MI
- Previous randomization in the present study
- Participation in a study with another investigational device or drug \< four weeks
Other illness
- Type 1 diabetes mellitus
- Any non-CV condition with a life expectancy of less than one year
- Known severe hepatic impairment (Cirrhosis)
- Known severe valvular heart disease
Lab values
- Severe renal impairment (eGFR \< 30 mL/min1.73m2 (based on prior or baseline blood work)
Age
- Age \< 18 years
Other
- Any contraindication to undergo CMR imaging
- Killip 4 (Cardiogenic shock on presentation)
- Pregnancy
- Nursing mother
- Unwilling to use appropriate forms of contraception, as applicable
- hospitalization
- Inability to provide informed consent
- Confirmed ketoacidosis at time of admission
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.