Dapagliflozin in STEMI Randomized Clinical Trial

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

Patients referred for PPCI meeting the following criteria are eligible for the study:

1. Ischemic chest discomfort of ≥30 minutes duration, and

2. Onset of chest pain ≤12 hours prior to entry into the study, and

3. 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:

• 1. Age < 18 years 2. Any contraindication to undergo CMR imaging 3. Killip 4 (Cardiogenic shock on presentation) 4. Therapy with SGLT2i within last 8 weeks 5. Type 1 diabetes mellitus 6. Pregnancy 7. Nursing mother 8. Unwilling to use appropriate forms of contraception, as applicable 9. Chronic symptomatic HF with prior hospitalization for HF within the last year 10. Known LVEF <40% by any prior measure, documented before the current MI hospitalization 11. Known history of prior MI 12. Any non-CV condition with a life expectancy of less than one year 13. Previous randomization in the present study 14. Participation in a study with another investigational device or drug < four weeks 15. Inability to provide informed consent

16. Confirmed ketoacidosis at time of admission 17. Known severe hepatic impairment (Cirrhosis) 18. Severe renal impairment (eGFR < 30 mL/min1.73m2 (based on prior or baseline blood work) 19. Known severe valvular heart disease 20. Need for CABG within 90 days based on the results of the initial coronary angiogram 21. False positive STEMI (based on the results of the coronary angiogram)