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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 3, 2009

Last Updated Date

December 22, 2010

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Infarct size by MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Infarct size by MRI [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00835848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cardiel death after 1 and 15 months. [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI

Official Title ^ICMJE

Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI in Patients With STEMI

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Infarction

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Not Provided

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00835848

Other Study ID Numbers ^ICMJE

KF 01 326257 b

Has Data Monitoring Committee

Not Provided

Responsible Party

Chief Consultant PhD, DSci, Thomas Engstrom, Rigshospitalet

Study Sponsor ^ICMJE

Rigshospitalet, Denmark

Collaborators ^ICMJE

University Hospital, Gentofte, Copenhagen

Investigators ^ICMJE

Study Chair:

Thomas Engstrom, MD, PhD, DSci

Rigshospitalet, Denmark

Information Provided By

Rigshospitalet, Denmark

Verification Date

January 2009

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

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