Recruiting
Phase 2

Exenatide

Sponsor:

University Health Network, Toronto

Code:

NCT01938235

Conditions

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exenatide

Placebo

Study Details

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).

Conditions

Myocardial Infarction

Study ID

NCT01938235

Start date

Feb, 2014

Status verified date

Aug, 2016

Completion date

Jan, 2018

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

198 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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\*.

Interventions

Exenatide

Intravenous bolus and 24-hour infusion of exenatide

Placebo

Intravenous bolus and 24-hour infusion of placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Val Panzov, MD

416-864-6060panzovV@smh.ca

Melissa Giamou, BSc

416-864-6060giamoum@smh.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Linda Manasterski

403-210-8548linda.manasterski@albertahealthservices.ca

Principal Investigator:

Faisal Al Qoofi, MD

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5H 3V9

Contacts

Linda Kvill

780-735-5255linda.kvill@albertahealthservices.ca

Principal Investigator:

Neil Brass, MD

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Suzanne Welsh

780-407-3572suzanne.welsh@albertahealthservices.ca

Principal Investigator:

Robert Welsh, MD

Hamilton Health Sciences - General Site

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Sonya Brons

905-527-4322bronsson@hhsc.ca

Principal Investigator:

Sanjit Jolly, MD

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Mistre Alemayehu

519-685-8500mistre.alemayehu@lhsc.on.ca

Principal Investigator:

Shahar Lavi, MD

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2P7

Contacts

Kim Robbins

905-235-5966kim.yorkpci@gmail.com

Principal Investigator:

Warren Cantor, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Suneet Khurana

416-480-4520suneet.khurana@sunnybrook.ca

Principal Investigator:

Mina Madan, MD

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Brigita Zile

416-864-6060zileb@smh.ca

Principal Investigator:

John J Graham, MD

Toronto General Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Nadia Asif

416-340-4800nadia.asif@uhn.ca

Principal Investigator:

Vladimir Dzavik, MD

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

Recruiting

Quebec City, Quebec, Canada, G1V 4G5

Contacts

Michele Jadin

418-656-8711michele.jadin@criucpq.ulaval.ca

Principal Investigator:

Olivier Bertrand, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 5, 2016

Last verified

Aug, 2016

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2016-08-05.