The effect of ITF-1697 on reperfusion in patients undergoing primary angioplasty: Safety and efficacy of a novel tetrapeptide, ITF-1697

ITF-1697 is a C-reactive protein-derived tetrapeptide that, based on pre-clinical studies, is thought to reduce reperfusion injury. We performed a dose-finding study to assess safety, preliminary efficacy and clinical outcome of prolonged i.v. infusion of ITF-1697 in patients with an acute myocardia...

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Bibliographic Details
Published in:European heart journal 2004-03, Vol.25 (5), p.392-400
Main Authors: DIRKSEN, Maurits T, LAARMAN, Gertjan, VAN'T HOF, Arnoud W. J, GUAGLIUMI, Giulio, TONINO, Wilhelmus A. L, TAVAZZI, Luigi, DUNCKER, Dirk J. G. M, SIMOONS, Maarten L
Format: Article
Language:English
Subjects:
Adult
Aged
Biological and medical sciences
C-Reactive Protein - analogs & derivatives
Cardiology. Vascular system
Coronary heart disease
Double-Blind Method
Electrocardiography
Female
Heart
Humans
Infusions, Intravenous
Male
Medical sciences
Middle Aged
Myocardial Infarction - drug therapy
Myocardial Reperfusion - methods
Myocardial Reperfusion Injury - prevention & control
Myocarditis. Cardiomyopathies
Oligopeptides - therapeutic use
Treatment Outcome
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Summary:ITF-1697 is a C-reactive protein-derived tetrapeptide that, based on pre-clinical studies, is thought to reduce reperfusion injury. We performed a dose-finding study to assess safety, preliminary efficacy and clinical outcome of prolonged i.v. infusion of ITF-1697 in patients with an acute myocardial infarction (AMI) who were eligible for percutaneous coronary intervention (PCI). This was a multicentre dose-finding study that was randomised, double blind, and placebo-controlled. Four hundred and two patients were enrolled. Intravenous infusion of four dosages of ITF-1697 (0.1, 0.5, 1.0 or 2.0 microg/kg/min) or placebo was started before PCI and continued for 24 h. After interim analysis of data from 242 patients the study continued with the 0.1 and 1.0 microg/kg/min ITF-1697 regimes. Analysis did not raise any safety concerns. Post-procedure perfusion, assessed by TIMI flow, corrected TIMI frame count, blushgrade and ST-segment resolution, was similar for the placebo, 0.1 and 1.0 microg/kg/min regimes. Furthermore, the results showed no differences between the treatment regimes in enzymatic infarct size or clinical outcome up to 30 days. ITF-1697 was well tolerated. However, neither a dose-relation nor improvement of perfusion, clinical outcome or reduction of myocardial damage could be demonstrated with ITF-1697 during and after primary PCI for AMI.
ISSN:0195-668X
1522-9645
DOI:10.1016/j.ehj.2003.12.018