Prasugrel compared with high-dose clopidogrel in acute coronary syndrome

Gilles Montalescot; Georgios Sideris; Remy Cohen; Catherine Meuleman; Claire Bal dit Sollier; Olivier Barthélémy; Patrick Henry; Pascal Lim; Farzin Beygui; Jean-Philippe Collet; Debra Marshall; Junxiang Luo; Helene Petitjean; Ludovic Drouet

doi:10.1160/TH09-07-0482

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2010; 103(01): 213-223
DOI: 10.1160/TH09-07-0482

New Technologies, Diagnostic Tools and Drugs

Schattauer GmbH

Prasugrel compared with high-dose clopidogrel in acute coronary syndrome

The randomised, double-blind ACAPULCO* study

Gilles Montalescot

¹Institut de Cardiologie (AP-HP), INSERM U856 and Université Paris 6, Hôpital Pitié-Salpêtrière, Paris, France

,

Georgios Sideris

²Hôpital Lariboisière and Université Paris 7, Paris, France

,

Remy Cohen

³Hôpital H Mondor and Université Paris 12, Paris, France

,

Catherine Meuleman

⁴Hôpital Saint-Antoine and Université Paris 6, Paris, France

,

Claire Bal dit Sollier

²Hôpital Lariboisière and Université Paris 7, Paris, France

,

Olivier Barthélémy

¹Institut de Cardiologie (AP-HP), INSERM U856 and Université Paris 6, Hôpital Pitié-Salpêtrière, Paris, France

,

Patrick Henry

²Hôpital Lariboisière and Université Paris 7, Paris, France

,

Pascal Lim

³Hôpital H Mondor and Université Paris 12, Paris, France

,

Farzin Beygui

¹Institut de Cardiologie (AP-HP), INSERM U856 and Université Paris 6, Hôpital Pitié-Salpêtrière, Paris, France

,

Jean-Philippe Collet

¹Institut de Cardiologie (AP-HP), INSERM U856 and Université Paris 6, Hôpital Pitié-Salpêtrière, Paris, France

,

Debra Marshall

⁵Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA

,

Junxiang Luo

⁵Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA

,

Helene Petitjean

⁶Daiichi Sankyo, Inc., Parsippany, New Jersey, USA

,

Ludovic Drouet

²Hôpital Lariboisière and Université Paris 7, Paris, France

› Author Affiliations

Abstract

Summary

Compared with the approved dose regimen of clopidogrel (300-mg loading dose [LD], 75-mg maintenance dose [MD]), prasugrel has been demonstrated to reduce ischaemic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). In ACS, antiplatelet effects of a prasugrel MD regimen have not been previously compared with either a higher clopidogrel MD or after switching from a higher clopidogrel LD. The objective of this study was to evaluate the antiplatelet effect of a prasugrel 10-mg MD versus a clopidogrel 150-mg MD in patients with ACS who had received a clopidogrel 900-mg LD. Patients with non-ST elevation ACS, treated with aspirin and a clopidogrel 900-mg LD, were randomised within 24 hours post-LD to receive a prasugrel 10-mg or clopidogrel 150-mg MD. After 14 days of the initial MD, subjects switched to the alternative treatment for 14 days. The primary endpoint compared maximum platelet aggregation (MPA, 20 μM adenosine diphosphate [ADP]) between prasugrel and clopidogrel MDs for both periods. Responder analyses between treatments were performed using several platelet-function methods. Of 56 randomised subjects, 37 underwent PCI. MPA was 26.2% for prasugrel 10 mg and 39.1% for clopidogrel 150 mg (p<0.001). The prasugrel MD regimen reduced MPA from the post-900-mg LD level (41.2% to 29.1%, p=0.003). Poor response ranged from 0% to 6% for prasugrel 10 mg and 4% to 34% for clopidogrel 150 mg. Thus, in ACS patients a prasugrel 10-mg MD regimen resulted in significantly greater platelet inhibition than clopidogrel at twice its approved MD or a 900-mg LD.

Keywords

Prasugrel - high-dose clopidogrel - thienopyridine switching

Full Text

References

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