| NCT ID | NCT06174753 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | ST Elevation Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 256 participants in total. It began in 2025-01-20 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Michel LeMay, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT06174753 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06174753 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 256 participants.
Is NCT06174753 currently recruiting?
Yes, NCT06174753 is actively recruiting participants. Contact the research team at pmacphee@ottawaheart.ca for enrollment information.
Where is the NCT06174753 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06174753 clinical trial?
NCT06174753 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Michel LeMay, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 256 participants.