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Trial · Interventional

CompletedPhase 4Registry data

Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI

Short name POSTCON II

NCTNCT00835848 (opens ClinicalTrials.gov in a new tab)Other idKF 01 326257 b
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
100 participants (estimated)
Sponsor
Copenhagen University Hospital, Rigshospitalet · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Jan 2009
Primary completion
Dec 2009
Completion
May 2015
First posted
4 Feb 2009 (estimated)
Last update posted
5 May 2015 (estimated)
Conditions
Myocardial Infarction

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201220142016
  1. Ph 4

    POSTCON II

    NCT00835848

    Jan 2009 to May 2015

Registry summary

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

Both pre- and postconditioning seem to protect cardiomyocytes during reperfusion therapy. Investigations both ex vivo and in vivo suggest that a gut derived hormone, Glucagon-Like-Peptide-1 (GLP-1), is able to reduce reperfusioninjury after myocardial ischemia. Results from our own laboratory have shown a marked reduction in infarct size when rat hearts in a Langendorf preparation were exposed to the GLP-1 analogue, exendin-4. The investigators want to investigate to what extent this effect can be translated to humans in the setting of acute STEMI treated with primary PCI when evalutaed by cardiac magnetic resonance imaging.

Interventions

  • ExenatideDrug
  • SalineDrug

Arms2

  • Active comparator

    Exenatide

    25 μg Byetta (Lilly, Exenatide) is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

  • Placebo comparator

    Saline

    Isotonic saline infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Infarct size by MRI

    Time frame · 3 months

Secondary outcomes(1)

  1. Cardiel death after 1 and 15 months.

    Time frame · 15 months

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 · 2012

8 results

Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction.

Lønborg et al. 2012European heart journalcited by 421

PMID 21920963DOI 10.1093/eurheartj/ehr309PUB-21920963

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Randomized controlled trial · 2012

6 results

Exenatide reduces final infarct size in patients with ST-segment-elevation myocardial infarction and short-duration of ischemia.

Lønborg et al. 2012Circulation. Cardiovascular interventionscited by 181

PMID 22496084DOI 10.1161/circinterventions.112.968388PUB-22496084

Full text at the publisher6 results
Publisher pageSee results (6)

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 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * More than 18 years of age. * STEMI less than 12 hours from onset of pain. STEMI defined as as ST-segment elevation in 2 contiguous electrocardiographic leads of \>0.1 mV in V4 - V6 or limb leads II, III and aVF, or \>0.2 mV in lead V1 - V3. * TIMI 0-1 in infarct related artery. * Oral and written informed consent. Exclusion Criteria: * Multivessel disease defined by one or more stenoses \>70% in diameter in the non infarct related artery. * Previous myocardial infarction. * Stent trombosis. * Previous CABG. * Less than TIMI 2 following wiring and predilatation of the infarct related artery but prior to postconditioning or placebo treatment. * Renal insufficiency (creatinin \>200). * Pregnancy or lactation. * Diabetic ketoacidose eller hypoglycemia (plasma glukose \< 2.5 mmol/l). * Pancreatitis.

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