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

AbstractAIM:
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 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.
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.
AuthorsMaurits T Dirksen, GertJan Laarman, Arnoud W J van 't Hof, Giulio Guagliumi, Wilhelmus A L Tonino, Luigi Tavazzi, Dirk J G M Duncker, Maarten L Simoons, PARI-MI Investigators (Protect Against Reperfusion Injury with ITF-1697 in acute Myocardial Infarction)
JournalEuropean heart journal (Eur Heart J) Vol. 25 Issue 5 Pg. 392-400 (Mar 2004) ISSN: 0195-668X [Print] England
PMID15033251 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Oligopeptides
  • glycyl-(ethyl)lysyl-prolyl-arginine
  • C-Reactive Protein
Topics
  • Adult
  • Aged
  • C-Reactive Protein (analogs & derivatives)
  • Double-Blind Method
  • Electrocardiography
  • Female
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Myocardial Infarction (drug therapy)
  • Myocardial Reperfusion (methods)
  • Myocardial Reperfusion Injury (prevention & control)
  • Oligopeptides (therapeutic use)
  • Treatment Outcome

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