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Trial · Interventional

CompletedPhase 4Registry data

Myocardial Protection of Exenatide in AMI

Short name EMPIRE

NCTNCT01580514 (opens ClinicalTrials.gov in a new tab)Other idKHMC-2012001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
127 participants (actual)
Sponsor
Kyunghee University Medical Center · Other
Design
Randomized · Single masking
Countries
1 country

South Korea

Start
Sept 2009
Primary completion
Aug 2011
Completion
Aug 2011
First posted
19 Apr 2012 (estimated)
Last update posted
19 Apr 2012 (estimated)
Conditions
Myocardial Infarction

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 4

    EMPIRE

    NCT01580514

    Sept 2009 to Aug 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has significant cardiovascular protective effects in various conditions. The investigators examined whether conventional use of exenatide at the time of primary percutaneous coronary intervention would reduce the infarct size in patients with ST-segment elevation myocardial infarction (STEMI).

Interventions

  • exenatide BYETTA® (Amylin-Lilly)Drug
  • SalineDrug

Arms2

  • Active comparator

    Exenatide

    Drug: Exenatide 10 μg subcutaneous and 10 μg intravenously injection of exenatide BYETTA® (Amylin-Lilly) 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.

  • Placebo comparator

    Saline

    Drug: Saline 10 μg subcutaneous and 10 μg intravenously injection of equivalent volume of normal saline 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Infarct size

    Time frame · 1 month

    Registry description

    Infarct size was assessed by measuring the release of creatine kinase-MB and troponin I during 72 hours and by performing cardiac magnetic resonance imaging on 1 month after infarction.

Secondary outcomes(3)

  1. Number of Participants with Adverse Events

    Time frame · 6 month after primary PCI

    Registry description

    Adverse events of exenatide such as hypoglycemia, nausea, vomiting, and chest pain aggravation were monitored during study period.

  2. LV function

    Time frame · at admission and 6 month after primary PCI

    Registry description

    Conventional and speckle tracking echocardiography was performed at initial presentation and 3 days and 6 months after primary PCI.

  3. Clinical outcomes

    Time frame · 6 months after primary PCI

    Registry description

    During 6-month follow up, clinical outcomes such as all death, repeated myocardial infarction or repeated PCI were also assessed.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2013

6 results

Cardioprotective effects of exenatide in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of exenatide myocardial protection in revascularization study.

Woo et al. 2013Arteriosclerosis, thrombosis, and vascular biologycited by 183

PMID 23868944DOI 10.1161/atvbaha.113.301586PUB-23868944

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Animal study · 2009

12 results

Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury.

Timmers et al. 2009Journal of the American College of Cardiologycited by 361

PMID 19195607DOI 10.1016/j.jacc.2008.10.033PUB-19195607

Full text at the publisher12 results
Publisher pageSee results (12)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHuang M, Wei R, Wang Y, Su T, Li Q, Yang X, Chen X. Protective effect of glucagon-like peptide-1 agents on reperfusion injury for acute myocardial infarction: a meta-analysis of randomized controlled trials. Ann Med. 2017 Nov;49(7):552-561. doi: 10.1080/07853890.2017.1306653. Epub 2017 Mar 31. PMID 28286967

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * age between 20 and 79 years * patients presenting with first ST-segment elevation myocardial infarction * Thrombolysis in Myocardial Infarction \[TIMI\] flow grade 0) Exclusion Criteria: * cardiac arrest * ventricular fibrillation * cardiogenic shock * hemodynamic instability * suspicious stent thrombosis * left bundle branch block * previous acute myocardial infarction * previous coronary artery bypass operation * significant valvular heart disease * primary myocardial disease * atrial fibrillation * significant hepatic or renal dysfunction, hypoglycaemia, * diabetic ketoacidosis * active infection or chronic inflammatory disease * malignancy * women who were pregnant or who were of childbearing age

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