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Evaluation of the antiplatelet effect of intravenous clopidogrel (MDCO-157) versus oral clopidogrel


La Grande Journée du Coeur (13 juin 2023)
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A phase I, randomized, open-label, crossover study to evaluate the antiplatelet effect of intravenous clopidogrel (MDCO-157) versus oral clopidogrel

date de réalisation


nombre de patients


nombre de centres participants

Monocentrique (Pitié-Salpêtrière)

type de financement

Privé (The Medicines Company)



Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Open-label, Randomized, Cross-over Evaluation (AMPHORE)

Study Description

Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs), this study, to be conducted in approximately 36 NHVs, will provide pertinent information in determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12 receptor inhibition effects and in selection of doses that match the antiplatelet effects of 300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK), safety and tolerability of single doses of MDCO-157.



  • Intravenous Clopidogrel (MDCO-157) Compared with Oral Clopidogrel : The Randomized Cross-Over AMPHORE Study
    Jean-Philippe Collet, Christian Funck-Brentano, Jayne Prats, Joe-Elie Salem, Jean-Sébastien Hulot, Edith Guilloux, Ming-yi Hu, Kan He, Johanne Silvain Vanessa Gallois, Delphine Brugier, Ghalia Anzaha, Sophie Galier, Nathalie Nicolas, Gilles Montalescot
    Publicated in American Journal of Cardiovascular Drugs

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