The effect of ITF-1697 on reperfusion in patients undergoing primary angioplasty. Safety and efficacy of a novel tetrapeptide, ITF-1697
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 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.
|Keywords||9007-41-4, Adult, Aged, C-Reactive Protein, Double-Blind Method, Electrocardiography, Female, Human, Intravenous Infusions, Male, Middle Aged, Myocardial Infarction, Myocardial Reperfusion, Myocardial Reperfusion Injury, Oligopeptides, Support, Treatment Outcome, acute myocardial infarction, analogs, coronary microcirculation, derivatives, drug therapy, glycyl-(ethyl)lysyl-prolyl-arginine, inflammation, primary percutaneous intervention, randomisation, reperfusion injury|
|Persistent URL||dx.doi.org/10.1016/j.ehj.2003.12.018, hdl.handle.net/1765/5726|
Dirksen, M.T., Laarman, G-J., Giualiumi, G., Tonino, W.A.L., Tavazzi, L., Simoons, M.L., … Duncker, D.J.G.M.. (2004). The effect of ITF-1697 on reperfusion in patients undergoing primary angioplasty. Safety and efficacy of a novel tetrapeptide, ITF-1697. European Heart Journal, 25(5), 392–400. doi:10.1016/j.ehj.2003.12.018