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Glucagon-like peptide-1 receptor agonist
Exenatide for Heart Attack (EMPRES Trial)
Phase 2
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
EMPRES Trial Summary
This study aims to assess the effect of exenatide on myocardial injury in patients undergoing emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction or heart attack (STEMI).
Eligible Conditions
- Heart Attack
EMPRES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ratio of final infarct size at 3 months over area at risk at 72 hours post randomization (using cMRI)
Secondary outcome measures
Angiographic myocardial blush score
Blood glucose < 3.0 mmol/L
Cardiogenic shock
+17 moreSide effects data
From 2017 Phase 4 trial • 8 Patients • NCT0205894038%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Exenatide
EMPRES Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExenatideExperimental Treatment1 Intervention
o Exenatide at a dose of 1.5 µg IV over 30 min followed by 1.2 µg/hr IV for 1.5 h (Rate1), followed by 1.9 µg/hr IV* for 22 h (Rate 2)
*Once the creatinine clearance is available, if the value is <60 mL/min, the rate at 2 hours will be maintained at Rate 1 for the duration of the infusion. If the value becomes available after the 2-hour point, and the rate has already been changed to Rate 2, the infusion will be titrated back down to Rate 1 if the creatinine clearance is <60 mL/min.
If the creatinine clearance is <30 mL/min, the infusion will be discontinued and the patient will otherwise continue with all study procedures.
A bolus administration of study medication is initiated preferably prior to reperfusion, or, if not possible, up to 30 minutes after the start of reperfusion to avoid delays in door-to-door balloon times.
Group II: PlaceboPlacebo Group1 Intervention
o Placebo bolus over 30 min followed by placebo infusion at 'Rate 1' for 1.5 h, followed by 'Rate 2' for 22 hours*.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exenatide
FDA approved
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,321 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,588 Total Patients Enrolled
Vladimir Dzavik, MDStudy ChairUniversity Health Network, Toronto
4 Previous Clinical Trials
964 Total Patients Enrolled
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