NCT01938235

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

3.4 years

First QC Date

August 29, 2013

Last Update Submit

August 3, 2016

Conditions

Myocardial Infarction

Keywords

Myocardial infarctionPercutaneous coronary interventionReperfusion injuryExenatideMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (31)

  • Left ventricular global and regional LV systolic ejection fraction

    72 hours

  • Left ventricular global and regional LV systolic ejection fraction

    3 months

  • Left ventricular volume

    72 hours

  • Left ventricular volume

    3 months

  • Infarct size/area of risk (measured by cMRI)

    3 months

  • +26 more secondary outcomes

Study Arms (2)

Exenatide

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

ExenatideDRUG

Intravenous bolus and 24-hour infusion of exenatide

Also known as: Byetta
Exenatide
PlaceboDRUG

Intravenous bolus and 24-hour infusion of placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Foothills Medical Centre

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Hamilton Health Sciences - General Site

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P7, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

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

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionReperfusion Injury

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPostoperative Complications

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Vladimir Dzavik, MD

    University Health Network, Toronto

    STUDY CHAIR

Central Study Contacts

Val Panzov, MD

CONTACT

416-864-6060panzovV@smh.ca

Melissa Giamou, BSc

CONTACT

416-864-6060giamoum@smh.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Research and Innovation in Interventional Cardiology and Cardiac Intensive Care, Division of Cardiology

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 10, 2013

Study Start

February 1, 2014

Primary Completion

July 1, 2017

Study Completion

January 1, 2018

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations

CA(10)