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


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.


CONCLUSIONS
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.
Dirksen
Maurits T
MT
Amsterdam Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, 1e Oosterparkstraat 279, 1090 Amsterdam, The Netherlands.
Laarman
GertJan
G
van 't Hof
Arnoud W J
AW
Guagliumi
Giulio
G
Tonino
Wilhelmus A L
WA
Tavazzi
Luigi
L
Duncker
Dirk J G M
DJ
Simoons
Maarten L
ML
D000328:Adult; D000368:Aged; D002097:C-Reactive Protein / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D015425:Myocardial Reperfusion / Q000379:methods*; D015428:Myocardial Reperfusion Injury / Q000517:prevention & control*; D009842:Oligopeptides / Q000627:therapeutic use*; D016896:Treatment Outcome
D009842:Oligopeptides; C487621:glycyl-(ethyl)lysyl-prolyl-arginine; D002097:C-Reactive Protein