Exenatide for Myocardial Protection During Reperfusion Study (EMPRES)

August 3, 2016 updated by: Vladimír Džavík, University Health Network, Toronto

Exenatide for Myocardial Protection During Reperfusion Study: A Double-blind, Placebo-controlled Trial

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II randomized, double-blind, placebo-controlled study of patients with STEMI. Those who agree to participate will be immediately randomized to one of two groups: a 24-h infusion of exenatide; or a 24 h infusion of placebo. We will assess the ability of exenatide to reduce ischemic injury. This study will serve as safety evaluation study as well as a pilot for a larger multicentre trial powered for clinical outcomes.

Study Type

Interventional

Enrollment (Anticipated)

198

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Val Panzov, MD
  • Phone Number: 7125 416-864-6060
  • Email: panzovV@smh.ca

Study Contact Backup

  • Name: Melissa Giamou, BSc
  • Phone Number: 7889 416-864-6060
  • Email: giamoum@smh.ca

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
      • Edmonton, Alberta, Canada, T6G 2B7
      • Edmonton, Alberta, Canada, T5H 3V9
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton Health Sciences - General Site
        • Contact:
        • Principal Investigator:
          • Sanjit Jolly, MD
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Centre
        • Contact:
      • Newmarket, Ontario, Canada, L3Y 2P7
        • Recruiting
        • Southlake Regional Health Centre
        • Contact:
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Contact:
          • Brigita Zile
          • Phone Number: 4130 416-864-6060
          • Email: zileb@smh.ca
        • Principal Investigator:
          • John J Graham, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Mina Madan, MD
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital, University Health Network
        • Contact:
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G5
        • Recruiting
        • Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
        • Contact:
        • Principal Investigator:
          • Olivier Bertrand, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission for primary PCI for STEMI, with enrollment within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥1mm in 2 or more limb leads, or ≥2mm in 2 or more precordial leads, or new onset LBBB) associated with acute chest pain or an elevation of cardiac enzymes.
  • Antegrade TIMI 0 or 1 prior to PCI in the infarct-related artery
  • Age ≥18 years

Exclusion Criteria:

  • Symptomatic hypoglycemia (serum glucose <3.3 µmol/L; 60 mg/dl)
  • Diabetes mellitus requiring insulin therapy
  • Diabetic ketoacidosis
  • Coronary anatomy warranting emergent coronary artery bypass graft surgery
  • Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation)
  • Need for hemodialysis
  • Malignancy, HIV, or central nervous system disorder
  • Cardiopulmonary resuscitation >15 min and compromised level of consciousness.
  • Cardiogenic shock
  • Current participation in any research study involving investigational drugs or devices
  • Inability to give informed consent
  • Inability to safely undergo cMRI (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant, severe claustrophobia)
  • Women of childbearing potential who are known to be pregnant or lactating or who have a positive pregnancy test on admission
  • History of pancreatitis
  • Known end stage renal failure or known eGFR <30 mL/min
  • Currently taking exenatide (Byetta, Bydureon), liraglutide (Victoza), or any other GLP-1 agonist

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exenatide

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.
Drug: Exenatide
Intravenous bolus and 24-hour infusion of exenatide
Other Names:
  • Byetta
PLACEBO_COMPARATOR: Placebo
o Placebo bolus over 30 min followed by placebo infusion at 'Rate 1' for 1.5 h, followed by 'Rate 2' for 22 hours*.
Drug: Placebo
Intravenous bolus and 24-hour infusion of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ratio of final infarct size at 3 months over area at risk at 72 hours post randomization (using cMRI)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 6 months
6 months
Stroke
Time Frame: 6 months
6 months
Left ventricular global and regional LV systolic ejection fraction
Time Frame: 72 hours
72 hours
Left ventricular global and regional LV systolic ejection fraction
Time Frame: 3 months
3 months
Left ventricular volume
Time Frame: 72 hours
72 hours
Left ventricular volume
Time Frame: 3 months
3 months
Infarct size/area of risk (measured by cMRI)
Time Frame: 3 months
3 months
Myocardial enzyme levels (troponin I and CK-MB)
Time Frame: 24 hours
24 hours
ST segment elevation resolution (measured by ECG)
Time Frame: 1 hour
1 hour
ST segment elevation resolution (measured by ECG)
Time Frame: 24 hours
24 hours
ST segment elevation resolution (measured by ECG)
Time Frame: 72 hours
72 hours
ST segment elevation resolution (measured by ECG)
Time Frame: 3 months
3 months
Angiographic myocardial blush score
Time Frame: At the time of the PCI procedure
At the time of the PCI procedure
Serum glucose concentration
Time Frame: Baseline
Baseline
Serum glucose concentration
Time Frame: 8 hours
8 hours
Serum glucose concentration
Time Frame: 16 hours
16 hours
Serum glucose concentration
Time Frame: 24 hours
24 hours
Serum glucose concentration
Time Frame: 72 hours
72 hours
Inflammatory marker levels (interleukin-6, interleukin-10, TNF-alpha)
Time Frame: 24 hours
24 hours
NT-proBNP blood levels
Time Frame: 24 hours
24 hours
Death
Time Frame: 3 months
3 months
Myocardial infarction (heart attack)
Time Frame: 3 months
3 months
Measure of extent of heart failure (NYHA classification)
Time Frame: 72 hours
72 hours
Measure of extent of heart failure (NYHA classification)
Time Frame: 3 months
3 months
Major adverse cardiac events (defined as a combined outcome of death, recurrent myocardial infarction, stroke, and unplanned repeat revascularization)
Time Frame: 6 months
6 months
Recurrent myocardial infarction (heart attack)
Time Frame: 6 months
6 months
Unplanned repeat revascularization
Time Frame: 6 months
6 months
Development of heart failure
Time Frame: 6 months
6 months
Cardiogenic shock
Time Frame: During index hospitalization (up to 6 months)
During index hospitalization (up to 6 months)
Blood glucose < 3.0 mmol/L
Time Frame: During index hospitalization (up to 6 months)
During index hospitalization (up to 6 months)
Hypotension (defined as SBP <90 mmHg)
Time Frame: During index hospitalization (up to 6 months)
During index hospitalization (up to 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (ESTIMATE)

September 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB001-001
  • 9427-D0416-21C (OTHER: Health Canada)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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