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Myocardial InfarctionPhase 2EMPRESNCT01938235

Exenatide for Myocardial Protection During Reperfusion Study

A Phase 2 study testing Exenatide in people with Myocardial Infarction, run by University Health Network, Toronto at 10 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
Exenatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
198 participants
Where
10 sitesCanada
Study dates
Feb 2014to Jan 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

Val Panzov, MD contact

416-864-6060 ext. 7125

panzovV@smh.ca

Melissa Giamou, BSc contact

416-864-6060 ext. 7889

giamoum@smh.ca

10 sites in 1 country

Canada10 sites, 10 recruiting

  • Foothills Medical Centre

    Calgary, Alberta, T2N 4Z6

    Linda Manasterski, 403-210-8548, linda.manasterski@albertahealthservices.ca

    Faisal Al Qoofi, MD

    Recruiting

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

    Linda Kvill, 780-735-5255, linda.kvill@albertahealthservices.ca

    Neil Brass, MD

    Recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

    Suzanne Welsh, 780-407-3572, suzanne.welsh@albertahealthservices.ca

    Robert Welsh, MD

    Recruiting

  • Hamilton Health Sciences - General Site

    Hamilton, Ontario, L8L 2X2

    Sonya Brons, 905-527-4322 ext. 44602, bronsson@hhsc.ca

    Sanjit Jolly, MD

    Recruiting

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

    Mistre Alemayehu, 519-685-8500 ext. 35625, mistre.alemayehu@lhsc.on.ca

    Shahar Lavi, MD

    Recruiting

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P7

    Kim Robbins, 905-235-5966, kim.yorkpci@gmail.com

    Warren Cantor, MD

    Recruiting

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

    Québec, Quebec, G1V 4G5

    Michele Jadin, 418-656-8711 ext. 3007, michele.jadin@criucpq.ulaval.ca

    Olivier Bertrand, MD

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Suneet Khurana, 416-480-4520, suneet.khurana@sunnybrook.ca

    Mina Madan, MD

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Brigita Zile, 416-864-6060 ext. 4130, zileb@smh.ca

    John J Graham, MD

    Recruiting

  • Toronto General Hospital, University Health Network

    Toronto, Ontario, M5G 2C4

    Nadia Asif, 416-340-4800 ext. 4969, nadia.asif@uhn.ca

    Vladimir Dzavik, MD

    Recruiting

Other trials in Canada

About this study

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

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).

Read the 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.

Being tested
Exenatide, Placebo
Keywords
Myocardial infarction, Percutaneous coronary intervention, Reperfusion injury, Exenatide, Magnetic resonance imaging
Medical subject headings
Myocardial Infarction, Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExenatideDrug

    Also called Byetta

    Intravenous bolus and 24-hour infusion of exenatide

  • PlaceboDrug

    Intravenous bolus and 24-hour infusion of placebo

Study groups in NCT01938235
Study groupRoleWhat they receive
ExenatideExperimentalo 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.
Receives: Drug: Exenatide
PlaceboPlacebo comparatoro Placebo bolus over 30 min followed by placebo infusion at 'Rate 1' for 1.5 h, followed by 'Rate 2' for 22 hours*.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (31)

  1. Left ventricular global and regional LV systolic ejection fraction

    Measured: 72 hours

  2. Left ventricular global and regional LV systolic ejection fraction

    Measured: 3 months

  3. Left ventricular volume

    Measured: 72 hours

  4. Left ventricular volume

    Measured: 3 months

  5. Infarct size/area of risk (measured by cMRI)

    Measured: 3 months

  6. Myocardial enzyme levels (troponin I and CK-MB)

    Measured: 24 hours

  7. ST segment elevation resolution (measured by ECG)

    Measured: 1 hour

  8. ST segment elevation resolution (measured by ECG)

    Measured: 24 hours

  9. ST segment elevation resolution (measured by ECG)

    Measured: 72 hours

  10. ST segment elevation resolution (measured by ECG)

    Measured: 3 months

  11. Angiographic myocardial blush score

    Measured: At the time of the PCI procedure

  12. Serum glucose concentration

    Measured: Baseline

  13. Serum glucose concentration

    Measured: 8 hours

  14. Serum glucose concentration

    Measured: 16 hours

  15. Serum glucose concentration

    Measured: 24 hours

  16. Serum glucose concentration

    Measured: 72 hours

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

    Measured: 24 hours

  18. NT-proBNP blood levels

    Measured: 24 hours

  19. Death

    Measured: 3 months

  20. Myocardial infarction (heart attack)

    Measured: 3 months

  21. Measure of extent of heart failure (NYHA classification)

    Measured: 72 hours

  22. Measure of extent of heart failure (NYHA classification)

    Measured: 3 months

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

    Measured: 6 months

  24. Death

    Measured: 6 months

  25. Recurrent myocardial infarction (heart attack)

    Measured: 6 months

  26. Stroke

    Measured: 6 months

  27. Unplanned repeat revascularization

    Measured: 6 months

  28. Development of heart failure

    Measured: 6 months

  29. Cardiogenic shock

    Measured: During index hospitalization (up to 6 months)

  30. Blood glucose < 3.0 mmol/L

    Measured: During index hospitalization (up to 6 months)

  31. Hypotension (defined as SBP <90 mmHg)

    Measured: During index hospitalization (up to 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionJul 2017 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01938235
Sponsor's protocol ID
MB001-001
Other IDs
9427-D0416-21C
Acronym
EMPRES
Status last verified
Aug 2016
First submitted
29 Aug 2013
Last updated
5 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exenatide in people with Myocardial Infarction, run by University Health Network, Toronto at 10 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Val Panzov, MD (416-864-6060 ext. 7125, panzovV@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01938235.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.

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