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

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Exenatide; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00835848

KF 01 326257 b

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Exenatide

Active Comparator group

Description:

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.

Treatment:

Drug: Exenatide

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline