Myocardial Infarction, ST Elevation Myocardial Infarction
Conditions
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.
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 or placebo to take for 7 days. Participants will be prescribed study treatment i.e. dapagliflozin (10 mg) or placebo daily for 7 days. A CMR will be obtained at day 3-5 to assess for infarct size. Participants will have follow-up visits at 30, 90, and 180 days to assess for cardiovascular events.
Interventions
DRUGDapagliflozin 10mg Tab
Dapagliflozin 10 mg daily X 7 days
DIAGNOSTIC_TESTCMR
CMR 3-5 days post randomization
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
a single center, randomized, double-blind, parallel group study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct Size | 3-5 days | Infarct size (% of total LV mass) measured by CMR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Multiple Cardiac Adverse Events (MACE) | 3 months, and 6 months | A composite of death, reinfarction, stroke, or rehospitalization for HF |
| Number of participants with Cardiogenic Shock | during initial hospitalization (*up to 30 days) | Evaluated using the SCAI classification; only class C, D, or E will be adjudicated as a secondary outcome |
| Number of Participants with Acute Kidney Injury | 3 months, and 6 months | As defined according to the KDIGO definition |
Countries
Canada
Contacts
CONTACTPoppy MacPhee, BScN
CONTACTTanya Abarbanel
PRINCIPAL_INVESTIGATORMichel LeMay, MD
Ottawa Heart Institute Research Corporation
Outcome results
None listed