Status:
RECRUITING
Dapagliflozin in STEMI
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
ST Elevation Myocardial Infarction
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT06174753
Start Date
January 20 2025
End Date
September 1 2026
Last Update
April 6 2025
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7