Abstract | AIM: 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.
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Authors | Maurits 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) |
Journal | European heart journal
(Eur Heart J)
Vol. 25
Issue 5
Pg. 392-400
(Mar 2004)
ISSN: 0195-668X [Print] England |
PMID | 15033251
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Oligopeptides
- glycyl-(ethyl)lysyl-prolyl-arginine
- C-Reactive Protein
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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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