CLINICAL RESEARCH: ACUTE CORONARY SYNDROME
A Randomized Comparison of High Clopidogrel Loading Doses in Patients With Non–ST-Segment Elevation Acute Coronary Syndromes
The ALBION (Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis) Trial
Gilles Montalescot, MD, PhD*,1,*,
Georges Sideris, MD ,
Catherine Meuleman, MD ,
Claire Bal-dit-Sollier, MB ,1,
Nicolas Lellouche, MD||,
Ph. Gabriel Steg, MD¶,1,
Michel Slama, MD#,
Olivier Milleron, MD**,
Jean-Philippe Collet, MD, PhD*,
Patrick Henry, MD,
Farzin Beygui, MD, PhD*,
Ludovic Drouet, MD, PhD,1 for the ALBION Trial Investigators
* Institut de Cardiologie–Pitié-Salpêtriére University Hospital, Assistence Publique Hôpiteux de Paris (APHP), Paris, France.
Service de Cardiologie–Lariboisiére University Hospital, APHP, Paris, France.
Service de Cardiologie–Saint-Antoine University Hospital, APHP, Paris, France.
Laboratoire d’Hémostase–Lariboisière University Hospital, APHP, Paris, France.
|| Service de Cardiologie–Henri-Mondor University Hospital, APHP, Paris, France.
¶ Service de Cardiologie–Hôpital Bichat-Claude Bernard, APHP, Paris, France.
# Service de Cardiologie–Antoine Béclère University Hospital, APHP, Paris, France.
** Service de Cardiologie–Ambroise Paré University Hospital, APHP, Paris, France.
Manuscript received September 26, 2005;
revised manuscript received April 20, 2006,
accepted April 25, 2006.
* Reprint requests and correspondence to: Dr. Gilles Montalescot, Institut de Cardiologie, Bureau 2-236, Pitié-Salpêtrière Hospital, 47 Boulevard de l’Hôpital, 75013 Paris, France. (Email: gilles.montalescot{at}psl.aphp.fr).
OBJECTIVES: We sought to compare the antiplatelet effects of three clopidogrel loading doses (LDs).
BACKGROUND: Administration of a 300-mg clopidogrel LD is beneficial in situations requiring rapid platelet inhibition. Whether higher LDs can provide further benefits remains unknown.
METHODS: Patients (n = 103) with non–ST-segment elevation acute coronary syndromes were randomized to receive a 300-mg, 600-mg, or 900-mg clopidogrel LD, given on top of other standard therapy (including acetylsalicylic acid). The main outcome measure was inhibition of adenosine diphosphate-induced inhibition of platelet aggregation (IPA); inhibition of platelet activation, inflammatory markers, troponin I release, and major adverse cardiac events also were evaluated; all measures were blindly evaluated.
RESULTS: Compared with the 300-mg LD, greater doses were associated with significantly greater platelet inhibition, with dose-effect relationships observed for onset of action, maximal plateau, 24-h areas under the curves of IPA, and rates of low IPA (<10% at 6 h), using 20 µmol/l major adverse cardiac events. A significant dose-response was also observed for the vasodilator-stimulated phosphoprotein index, a measure of P2Y12 receptor inhibition. Similar but nonsignificant trends were observed for troponin release and major adverse cardiac events. Bleeding rates were similar in each group.
CONCLUSIONS: In low-to-moderate risk patients with non–ST-elevation acute coronary syndromes, clopidogrel LDs >300 mg provide a faster onset of action, a higher IPA plateau, and greater reductions in platelet activation during the first 24 h. A 900-mg LD may induce a greater antiplatelet effect than 600 mg, when compared with the standard 300-mg regimen. These findings require further clinical confirmation.
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Abbreviations and Acronyms
| | ADP = adenosine diphosphate | | ASA = acetylsalicylic acid | | AUC = area under the inhibition of platelet aggregation curve | | GP = glycoprotein | | IPA = inhibition of platelet aggregation | | LD = loading dose | | LMWH = low molecular weight heparin | | MACE = major adverse cardiac events | | MFI = median fluorescence intensity | | NSTE-ACS = non–ST-segment elevation acute coronary syndrome | | PA = platelet aggregation | | PAI = plasminogen activator inhibitor | | PCI = percutaneous coronary intervention | | PGE1 = prostaglandin E1 | | sCD40L = soluble CD40 ligand | | VASP = vasodilator-stimulated phosphoprotein | | vWF Ag = von Willebrand factor antigen |
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S. R. Mehta
Clopidogrel in non-ST-segment elevation acute coronary syndromes
Eur. Heart J. Suppl.,
October 1, 2006;
8(suppl_G):
G25 - G30.
[Abstract]
[Full Text]
[PDF]
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