Copyright © 2004 by the European Society of Cardiology.
Clinical research
The effect of ITF-1697 on reperfusion in patients undergoing primary angioplasty
Safety and efficacy of a novel tetrapeptide, ITF-1697
a Amsterdam Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, 1e Oosterparkstraat 279, 1090 Amsterdam, The Netherlands
b Isala Klinieken, De Weezenlanden, Zwolle, The Netherlands
c Ospedale Riuniti di Bergamo, Italy
d Catharina Ziekenhuis, Eindhoven, The Netherlands
e IRCCS Policlinico San Matteo, Pavia, Italy
f Department of Cardiology, Thoraxcentre, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands
* Corresponding author. Tel.: +31-0-20-5993032; fax: +31-0-20-5993997
E-mail address: g.j.laarman{at}olvg.nl
Received 30 January 2003; revised 12 December 2003; accepted 18 December 2003
Abstract
Aim 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).
Methods and results 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 µg/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 µg/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 µg/kg/min regimes. Furthermore, the results showed no differences between the treatment regimes in enzymatic infarct size or clinical outcome up to 30 days.
Conclusion 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.
Key Words: Reperfusion injury • Acute myocardial infarction • Primary percutaneous intervention • Inflammation • Drug therapy • Coronary microcirculation • Randomisation
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  M. T. Dirksen, G. J. Laarman, M. L. Simoons, and D. J.G.M. Duncker Reperfusion injury in humans: A review of clinical trials on reperfusion injury inhibitory strategies Cardiovasc Res, June 1, 2007; 74(3): 343 - 355. [Abstract] [Full Text] [PDF]
|
|