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Exenatide for Myocardial Protection During Reperfusion Study (EMPRES)

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ClinicalTrials.gov Identifier: NCT01938235
Recruitment Status : Unknown
Verified August 2016 by Vladimír Džavík, University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : September 10, 2013
Last Update Posted : August 5, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Vladimír Džavík, University Health Network, Toronto

Study Description
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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).

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Exenatide Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exenatide for Myocardial Protection During Reperfusion Study: A Double-blind, Placebo-controlled Trial
Study Start Date : February 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Exenatide

Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Left ventricular global and regional LV systolic ejection fraction [ Time Frame: 72 hours ]
  2. Left ventricular global and regional LV systolic ejection fraction [ Time Frame: 3 months ]
  3. Left ventricular volume [ Time Frame: 72 hours ]
  4. Left ventricular volume [ Time Frame: 3 months ]
  5. Infarct size/area of risk (measured by cMRI) [ Time Frame: 3 months ]
  6. Myocardial enzyme levels (troponin I and CK-MB) [ Time Frame: 24 hours ]
  7. ST segment elevation resolution (measured by ECG) [ Time Frame: 1 hour ]
  8. ST segment elevation resolution (measured by ECG) [ Time Frame: 24 hours ]
  9. ST segment elevation resolution (measured by ECG) [ Time Frame: 72 hours ]
  10. ST segment elevation resolution (measured by ECG) [ Time Frame: 3 months ]
  11. Angiographic myocardial blush score [ Time Frame: At the time of the PCI procedure ]
  12. Serum glucose concentration [ Time Frame: Baseline ]
  13. Serum glucose concentration [ Time Frame: 8 hours ]
  14. Serum glucose concentration [ Time Frame: 16 hours ]
  15. Serum glucose concentration [ Time Frame: 24 hours ]
  16. Serum glucose concentration [ Time Frame: 72 hours ]
  17. Inflammatory marker levels (interleukin-6, interleukin-10, TNF-alpha) [ Time Frame: 24 hours ]
  18. NT-proBNP blood levels [ Time Frame: 24 hours ]
  19. Death [ Time Frame: 3 months ]
  20. Myocardial infarction (heart attack) [ Time Frame: 3 months ]
  21. Measure of extent of heart failure (NYHA classification) [ Time Frame: 72 hours ]
  22. Measure of extent of heart failure (NYHA classification) [ Time Frame: 3 months ]
  23. Major adverse cardiac events (defined as a combined outcome of death, recurrent myocardial infarction, stroke, and unplanned repeat revascularization) [ Time Frame: 6 months ]
  24. Death [ Time Frame: 6 months ]
  25. Recurrent myocardial infarction (heart attack) [ Time Frame: 6 months ]
  26. Stroke [ Time Frame: 6 months ]
  27. Unplanned repeat revascularization [ Time Frame: 6 months ]
  28. Development of heart failure [ Time Frame: 6 months ]
  29. Cardiogenic shock [ Time Frame: During index hospitalization (up to 6 months) ]
  30. Blood glucose < 3.0 mmol/L [ Time Frame: During index hospitalization (up to 6 months) ]
  31. Hypotension (defined as SBP <90 mmHg) [ Time Frame: During index hospitalization (up to 6 months) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938235


Contacts
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Contact: Val Panzov, MD 416-864-6060 ext 7125 panzovV@smh.ca
Contact: Melissa Giamou, BSc 416-864-6060 ext 7889 giamoum@smh.ca

Locations
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Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Linda Manasterski    403-210-8548    linda.manasterski@albertahealthservices.ca   
Principal Investigator: Faisal Al Qoofi, MD         
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Linda Kvill    780-735-5255    linda.kvill@albertahealthservices.ca   
Principal Investigator: Neil Brass, MD         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Suzanne Welsh    780-407-3572    suzanne.welsh@albertahealthservices.ca   
Principal Investigator: Robert Welsh, MD         
Canada, Ontario
Hamilton Health Sciences - General Site Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Sonya Brons    905-527-4322 ext 44602    bronsson@hhsc.ca   
Principal Investigator: Sanjit Jolly, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Mistre Alemayehu    519-685-8500 ext 35625    mistre.alemayehu@lhsc.on.ca   
Principal Investigator: Shahar Lavi, MD         
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada, L3Y 2P7
Contact: Kim Robbins    905-235-5966    kim.yorkpci@gmail.com   
Principal Investigator: Warren Cantor, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Suneet Khurana    416-480-4520    suneet.khurana@sunnybrook.ca   
Principal Investigator: Mina Madan, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Brigita Zile    416-864-6060 ext 4130    zileb@smh.ca   
Principal Investigator: John J Graham, MD         
Toronto General Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Nadia Asif    416-340-4800 ext 4969    nadia.asif@uhn.ca   
Principal Investigator: Vladimir Dzavik, MD         
Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Quebec (Hopital Laval) Recruiting
Quebec City, Quebec, Canada, G1V 4G5
Contact: Michele Jadin    418-656-8711 ext 3007    michele.jadin@criucpq.ulaval.ca   
Principal Investigator: Olivier Bertrand, MD         
Sponsors and Collaborators
University Health Network, Toronto
AstraZeneca
Investigators
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Study Chair: Vladimir Dzavik, MD University Health Network, Toronto
More Information
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Responsible Party: Vladimír Džavík, Director, Research and Innovation in Interventional Cardiology and Cardiac Intensive Care, Division of Cardiology, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01938235    
Other Study ID Numbers: MB001-001
9427-D0416-21C ( Other Identifier: Health Canada )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Vladimír Džavík, University Health Network, Toronto:
Myocardial infarction
Percutaneous coronary intervention
Reperfusion injury
Exenatide
Magnetic resonance imaging
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists