Exenatide for Myocardial Protection During Reperfusion Study

Myocardial Infarction Clinical Trial

— EMPRES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01938235
• Other study ID #: MB001-001
• Secondary ID: 9427-D0416-21C
• Status: Recruiting
• Phase: Phase 2
• First received: August 29, 2013
• Last updated: August 3, 2016
• Start date: February 2014
• Est. completion date: January 2018

Study information

• Verified date: August 2016
• Source: University Health Network, Toronto
• Contact: Val Panzov, MD
• Phone: 416-864-6060
• Email: panzovV[@]smh.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: January 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Exenatide
Intravenous bolus and 24-hour infusion of exenatide
• Placebo
Intravenous bolus and 24-hour infusion of placebo

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences - General Site	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Institut universitaire de cardiologie et de pneumologie de Quebec (Hopital Laval)	Quebec City	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of final infarct size at 3 months over area at risk at 72 hours post randomization (using cMRI)		3 months	No
Secondary	Left ventricular global and regional LV systolic ejection fraction		72 hours	No
Secondary	Left ventricular global and regional LV systolic ejection fraction		3 months	No
Secondary	Left ventricular volume		72 hours	No
Secondary	Left ventricular volume		3 months	No
Secondary	Infarct size/area of risk (measured by cMRI)		3 months	No
Secondary	Myocardial enzyme levels (troponin I and CK-MB)		24 hours	No
Secondary	ST segment elevation resolution (measured by ECG)		1 hour	No
Secondary	ST segment elevation resolution (measured by ECG)		24 hours	No
Secondary	ST segment elevation resolution (measured by ECG)		72 hours	No
Secondary	ST segment elevation resolution (measured by ECG)		3 months	No
Secondary	Angiographic myocardial blush score		At the time of the PCI procedure	No
Secondary	Serum glucose concentration		Baseline	No
Secondary	Serum glucose concentration		8 hours	No
Secondary	Serum glucose concentration		16 hours	No
Secondary	Serum glucose concentration		24 hours	No
Secondary	Serum glucose concentration		72 hours	No
Secondary	Inflammatory marker levels (interleukin-6, interleukin-10, TNF-alpha)		24 hours	No
Secondary	NT-proBNP blood levels		24 hours	No
Secondary	Death		3 months	No
Secondary	Myocardial infarction (heart attack)		3 months	No
Secondary	Measure of extent of heart failure (NYHA classification)		72 hours	No
Secondary	Measure of extent of heart failure (NYHA classification)		3 months	No
Secondary	Major adverse cardiac events (defined as a combined outcome of death, recurrent myocardial infarction, stroke, and unplanned repeat revascularization)		6 months	Yes
Secondary	Death		6 months	Yes
Secondary	Recurrent myocardial infarction (heart attack)		6 months	Yes
Secondary	Stroke		6 months	Yes
Secondary	Unplanned repeat revascularization		6 months	Yes
Secondary	Development of heart failure		6 months	Yes
Secondary	Cardiogenic shock		During index hospitalization (up to 6 months)	Yes
Secondary	Blood glucose < 3.0 mmol/L		During index hospitalization (up to 6 months)	Yes
Secondary	Hypotension (defined as SBP <90 mmHg)		During index hospitalization (up to 6 months)	Yes