Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI (POSTCON II)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Rigshospitalet, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00835848
First received: February 3, 2009
Last updated: December 22, 2010
Last verified: January 2009

February 3, 2009
December 22, 2010
January 2009
December 2009   (final data collection date for primary outcome measure)
Infarct size by MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Infarct size by MRI [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00835848 on ClinicalTrials.gov Archive Site
Cardiel death after 1 and 15 months. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI
Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI in Patients With STEMI

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: Exenatide
    Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 25 μg Byetta (Lilly, Exenatide) and 0.1% human albumine are 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.
  • Drug: Saline
    Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 0.1% human albumine 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.
  • 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.
    Intervention: Drug: Exenatide
  • 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.
    Intervention: Drug: Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Not Provided
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00835848
KF 01 326257 b
Not Provided
Chief Consultant PhD, DSci, Thomas Engstrom, Rigshospitalet
Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
Study Chair: Thomas Engstrom, MD, PhD, DSci Rigshospitalet, Denmark
Rigshospitalet, Denmark
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP