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European Heart Journal Advance Access originally published online on October 9, 2006
European Heart Journal 2006 27(21):2516-2523; doi:10.1093/eurheartj/ehl304
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Results of the first clinical study of adjunctive CAldaret (MCC-135) in patients undergoing primary percutaneous coronary intervention for ST-Elevation Myocardial Infarction: the randomized multicentre CASTEMI study

Frits W. Bär1,*, Dan Tzivoni2, Maurits T. Dirksen3, Antonio Fernández-Ortiz4, Guy R. Heyndrickx5, Johannes Brachmann6, Johan H.C. Reiber7, Neelima Avasthy8, Jun Tatsuno9, Martin Davies8, Mark G. Hibberd10, Mitchell W. Krucoff11 on behalf of the CASTEMI Study Group

1 Department of Cardiology, University Hospital Maastricht, PO Box 5800, 6202 AZ Maastricht, The Netherlands
2 Shaare Zedek Medical Centre, Jerusalem, Israel
3 Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
4 Hospital Clinico San Carlos, Madrid, Spain
5 Onze Lieve Vrouwziekenhuis, Aalst, Belgium
6 Medizinischen Klinik, Coburg, Germany
7 Heart Core, Leiden, The Netherlands
8 Mitsubishi Pharma Europe Ltd, London, UK
9 Mitsubishi Pharma Corporation, Tokyo, Japan
10 CardioCorp, Lexington, MA, USA
11 Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA

Received 23 December 2005; revised 31 August 2006; accepted 21 September 2006; online publish-ahead-of-print 9 October 2006.

* Corresponding author. Tel: +31 43 3875098; fax: +31 43 3875104. E-mail address: f.baer{at}cardio.azm.nl

Aims To examine the safety and efficacy of intravenous caldaret in patients with large acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).

Methods and results STEMI patients (n=387) with ≥10 mm summed ST-deviation on electrocardiogram were randomized to receive a 48 h infusion of caldaret 57.5 mg [lower dose (LD)], caldaret 172.5 mg [higher dose (HD)], or placebo, starting before PCI. Both HD and LD were well tolerated. In 247 patients with pre-PCI TIMI 0/1, there was no effect of HD or LD on single photon emission computed tomography infarct size or ejection fraction assessed at Day 7 and Day 30. Subgroup analyses suggest that future work in patients with anterior MI might be warranted.

Conclusion This first human experience with caldaret prior to direct PCI for large STEMI shows a good safety profile. No evidence of efficacy was discerned. Subgroup analyses in anterior MI patients showed some effects in endpoints studied, however, these findings require confirmation in a further study if a drug effect is to be established.

Key Words: Reperfusion damage • Acute myocardial infarction • Primary PCI


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