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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
1   Institut de Cardiologie (AP-HP), INSERM U856 and Université Paris 6, Hôpital Pitié-Salpêtrière, Paris, France
,
Georgios Sideris
2   Hôpital Lariboisière and Université Paris 7, Paris, France
,
Remy Cohen
3   Hôpital H Mondor and Université Paris 12, Paris, France
,
Catherine Meuleman
4   Hôpital Saint-Antoine and Université Paris 6, Paris, France
,
Claire Bal dit Sollier
2   Hôpital Lariboisière and Université Paris 7, Paris, France
,
Olivier Barthélémy
1   Institut de Cardiologie (AP-HP), INSERM U856 and Université Paris 6, Hôpital Pitié-Salpêtrière, Paris, France
,
Patrick Henry
2   Hôpital Lariboisière and Université Paris 7, Paris, France
,
Pascal Lim
3   Hôpital H Mondor and Université Paris 12, Paris, France
,
Farzin Beygui
1   Institut de Cardiologie (AP-HP), INSERM U856 and Université Paris 6, Hôpital Pitié-Salpêtrière, Paris, France
,
Jean-Philippe Collet
1   Institut de Cardiologie (AP-HP), INSERM U856 and Université Paris 6, Hôpital Pitié-Salpêtrière, Paris, France
,
Debra Marshall
5   Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA
,
Junxiang Luo
5   Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA
,
Helene Petitjean
6   Daiichi Sankyo, Inc., Parsippany, New Jersey, USA
,
Ludovic Drouet
2   Hôpital Lariboisière and Université Paris 7, Paris, France
› Author Affiliations Financial support: The ACAPULCO trial was supported by Daiichi Sankyo Company, Limited, Tokyo, Japan and Eli Lilly and Company, Indianapolis, IN, USA.
Further Information

Publication History

Received: 27 July 2009

Accepted after minor revision: 14 September 2009

Publication Date:
22 November 2017 (online)

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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