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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Dapagliflozin 10mg daily X 7 days |
|
| Placebo | Placebo Comparator | Placebo daily X 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg Tab | Drug | Dapagliflozin 10 mg daily X 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct Size | Infarct size (% of total LV mass) measured by CMR | 3-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Multiple Cardiac Adverse Events (MACE) | A composite of death, reinfarction, stroke, or rehospitalization for HF | 3 months, and 6 months |
| Number of participants with Cardiogenic Shock |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Poppy MacPhee, BScN | Contact | 6136967000 | 14646 | pmacphee@ottawaheart.ca |
| Tanya Abarbanel | Contact | 613-696-7000 | tabarbanel@ottawaheart.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michel LeMay, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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a single center, randomized, double-blind, parallel group study
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| CMR |
| Diagnostic Test |
CMR 3-5 days post randomization |
|
Evaluated using the SCAI classification; only class C, D, or E will be adjudicated as a secondary outcome
| during initial hospitalization (*up to 30 days) |
| Number of Participants with Acute Kidney Injury | As defined according to the KDIGO definition | 3 months, and 6 months |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |