Back to results

Exenatide for Myocardial Protection During Reperfusion Study (EMPRES)

Primary Purpose

Myocardial Infarction

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Exenatide

Placebo

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Percutaneous coronary intervention, Reperfusion injury, Exenatide, Magnetic resonance imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Foothills Medical CentreRecruiting
Royal Alexandra HospitalRecruiting
University of Alberta HospitalRecruiting
Hamilton Health Sciences - General SiteRecruiting
London Health Sciences CentreRecruiting
Southlake Regional Health CentreRecruiting
Sunnybrook Health Sciences CentreRecruiting
St. Michael's HospitalRecruiting
Toronto General Hospital, University Health NetworkRecruiting
Institut universitaire de cardiologie et de pneumologie de Quebec (Hopital Laval)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exenatide

Placebo

Arm Description

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.

o Placebo bolus over 30 min followed by placebo infusion at 'Rate 1' for 1.5 h, followed by 'Rate 2' for 22 hours*.

Outcomes

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

Left ventricular global and regional LV systolic ejection fraction

Left ventricular volume

Infarct size/area of risk (measured by cMRI)

Myocardial enzyme levels (troponin I and CK-MB)

ST segment elevation resolution (measured by ECG)

Angiographic myocardial blush score

Serum glucose concentration

Inflammatory marker levels (interleukin-6, interleukin-10, TNF-alpha)

NT-proBNP blood levels

Death

Myocardial infarction (heart attack)

Measure of extent of heart failure (NYHA classification)

Major adverse cardiac events (defined as a combined outcome of death, recurrent myocardial infarction, stroke, and unplanned repeat revascularization)

Death

Recurrent myocardial infarction (heart attack)

Stroke

Unplanned repeat revascularization

Development of heart failure

Cardiogenic shock

Blood glucose < 3.0 mmol/L

Hypotension (defined as SBP <90 mmHg)

Full Information

NCT ID

NCT01938235

First Posted

August 29, 2013

Last Updated

August 3, 2016

Sponsor

University Health Network, Toronto

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01938235

Brief Title

Exenatide for Myocardial Protection During Reperfusion Study

Acronym

EMPRES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Health Network, Toronto

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Myocardial infarction, Percutaneous coronary intervention, Reperfusion injury, Exenatide, Magnetic resonance imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exenatide

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

o Placebo bolus over 30 min followed by placebo infusion at 'Rate 1' for 1.5 h, followed by 'Rate 2' for 22 hours*.

Intervention Type

Drug

Intervention Name(s)

Exenatide

Other Intervention Name(s)

Byetta

Intervention Description

Intravenous bolus and 24-hour infusion of exenatide

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous bolus and 24-hour infusion of placebo

Primary Outcome Measure Information:

Title

Ratio of final infarct size at 3 months over area at risk at 72 hours post randomization (using cMRI)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Left ventricular global and regional LV systolic ejection fraction

Time Frame

72 hours

Title

Left ventricular global and regional LV systolic ejection fraction

Time Frame

3 months

Title

Left ventricular volume

Time Frame

72 hours

Title

Left ventricular volume

Time Frame

3 months

Title

Infarct size/area of risk (measured by cMRI)

Time Frame

3 months

Title

Myocardial enzyme levels (troponin I and CK-MB)

Time Frame

24 hours

Title

ST segment elevation resolution (measured by ECG)

Time Frame

1 hour

Title

ST segment elevation resolution (measured by ECG)

Time Frame

24 hours

Title

ST segment elevation resolution (measured by ECG)

Time Frame

72 hours

Title

ST segment elevation resolution (measured by ECG)

Time Frame

3 months

Title

Angiographic myocardial blush score

Time Frame

At the time of the PCI procedure

Title

Serum glucose concentration

Time Frame

Baseline

Title

Serum glucose concentration

Time Frame

8 hours

Title

Serum glucose concentration

Time Frame

16 hours

Title

Serum glucose concentration

Time Frame

24 hours

Title

Serum glucose concentration

Time Frame

72 hours

Title

Inflammatory marker levels (interleukin-6, interleukin-10, TNF-alpha)

Time Frame

24 hours

Title

NT-proBNP blood levels

Time Frame

24 hours

Title

Death

Time Frame

3 months

Title

Myocardial infarction (heart attack)

Time Frame

3 months

Title

Measure of extent of heart failure (NYHA classification)

Time Frame

72 hours

Title

Measure of extent of heart failure (NYHA classification)

Time Frame

3 months

Title

Major adverse cardiac events (defined as a combined outcome of death, recurrent myocardial infarction, stroke, and unplanned repeat revascularization)

Time Frame

6 months

Title

Death

Time Frame

6 months

Title

Recurrent myocardial infarction (heart attack)

Time Frame

6 months

Title

Stroke

Time Frame

6 months

Title

Unplanned repeat revascularization

Time Frame

6 months

Title

Development of heart failure

Time Frame

6 months

Title

Cardiogenic shock

Time Frame

During index hospitalization (up to 6 months)

Title

Blood glucose < 3.0 mmol/L

Time Frame

During index hospitalization (up to 6 months)

Title

Hypotension (defined as SBP <90 mmHg)

Time Frame

During index hospitalization (up to 6 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Val Panzov, MD

Phone

416-864-6060

Ext

7125

panzovV@smh.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Giamou, BSc

Phone

416-864-6060

Ext

7889

giamoum@smh.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vladimir Dzavik, MD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Study Chair

Facility Information:

Facility Name

Foothills Medical Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Manasterski

Phone

403-210-8548

linda.manasterski@albertahealthservices.ca

First Name & Middle Initial & Last Name & Degree

Faisal Al Qoofi, MD

Facility Name

Royal Alexandra Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5H 3V9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Kvill

Phone

780-735-5255

linda.kvill@albertahealthservices.ca

First Name & Middle Initial & Last Name & Degree

Neil Brass, MD

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suzanne Welsh

Phone

780-407-3572

suzanne.welsh@albertahealthservices.ca

First Name & Middle Initial & Last Name & Degree

Robert Welsh, MD

Facility Name

Hamilton Health Sciences - General Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonya Brons

Phone

905-527-4322

Ext

44602

bronsson@hhsc.ca

First Name & Middle Initial & Last Name & Degree

Sanjit Jolly, MD

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mistre Alemayehu

Phone

519-685-8500

Ext

35625

mistre.alemayehu@lhsc.on.ca

First Name & Middle Initial & Last Name & Degree

Shahar Lavi, MD

Facility Name

Southlake Regional Health Centre

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 2P7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kim Robbins

Phone

905-235-5966

kim.yorkpci@gmail.com

First Name & Middle Initial & Last Name & Degree

Warren Cantor, MD

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suneet Khurana

Phone

416-480-4520

suneet.khurana@sunnybrook.ca

First Name & Middle Initial & Last Name & Degree

Mina Madan, MD

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brigita Zile

Phone

416-864-6060

Ext

4130

zileb@smh.ca

First Name & Middle Initial & Last Name & Degree

John J Graham, MD

Facility Name

Toronto General Hospital, University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadia Asif

Phone

416-340-4800

Ext

4969

nadia.asif@uhn.ca

First Name & Middle Initial & Last Name & Degree

Vladimir Dzavik, MD

Facility Name

Institut universitaire de cardiologie et de pneumologie de Quebec (Hopital Laval)

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michele Jadin

Phone

418-656-8711

Ext

3007

michele.jadin@criucpq.ulaval.ca

First Name & Middle Initial & Last Name & Degree

Olivier Bertrand, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Exenatide for Myocardial Protection During Reperfusion Study

We'll reach out to this number within 24 hrs