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ANTARCTIC

Multicentric, randomized open trial aiming to evaluate the interest of a dosis of Prasugrel (Efient®) adapted to a biological test Verifynow (Monitored Arm) in comparison to a fixed dose of Prasugrel (Conventional Arm) in patients aged over 75 and needing an angioplasty with stent apposing with the view of reducing bleeding and ischemic complications as well as stent thromboses

Terminée

Colloquium "Rythme et conduction" (23 avril 2024)
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La Grande Journée du Coeur (mardi 13 juin 2023)
Les présentations sont en ligne

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objectif

Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome

date de réalisation

2012

nombre de patients

877

nombre de centres participants

35 French centers

type de financement

Public (APHP) and private (Eli Lilly, Daiichi-Sankyo, Accriva diagnostics, Medtronic & Stentys)

Référence

NCT01538446

Assessment of a Normal Versus Tailored Dose of Prasugrel After Stenting in Patients Aged > 75 Years to Reduce the Composite of Bleeding, Stent Thrombosis and Ischemic Complications – (ANTARCTIC)

Study Description

To demonstrate the superiority of a strategy of platelet monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders as compared to a more conventional strategy of a fixed dose of 5 mg to every patient without monitoring (Conventional Arm).
Rationale : Prasugrel 10 mg is superior to clopidogrel in patients with acute coronary syndrome treated by percutaneous coronary intervention, reducing significantly the rates of ischemic events. Elderly patients appear to be at higher risk of bleeding events and pharmacokinetic data suggests that elderly patients are exposed to a higher concentration of the active metabolite of prasugrel. A reduced dose of 5 mg of prasugrel is therefore proposed to these patients to limit the risk of bleeding. On the other hand, the elderly have also a higher ischemic risk and higher levels of platelet aggregation under treatment than younger patients and may deserve stronger protection from antiplatelet therapy. Platelet function testing appears to be of particular interest in patients at high risk of both ischemic and bleeding events like the elderly. Too intense platelet inhibition may expose the elderly patients to an excessive bleeding risk. Too low platelet inhibition may expose them to recurrent cardiovascular ischemic events. The possibility of bedside monitoring of oral antiplatelet therapy offers the opportunity of tailoring prasugrel therapy in elderly patients to optimize their risk/benefit ratio. Such strategy has never been evaluated in a randomized and adequately powered study.
Population : Acute coronary syndrome (STEMI and NSTEMI) treated by PCI-stent (bare metal stent or drug eluting stent) in patients aged 75 ≥ year.
Methods : Monitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR). Patients will be monitored again 2 weeks later, only if they do not meet the Verifynow P2Y12 targets at the first assessment.

source clinicaltrials.gov

Publications

  • Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome (ANTARCTIC) : an open-label, blinded-endpoint, randomised controlled superiority trial
    Guillaume Cayla, Thomas Cuisset, Johanne Silvain, Florence Leclercq, Stephane Manzo-Silberman, Christophe Saint-Etienne, Nicolas Delarche, Anne Bellemain-Appaix, Grégoire Range, Rami El Mahmoud, Didier Carrié, Loic Belle, Geraud Souteyrand, Pierre Aubry, Pierre Sabouret, Xavier Halna du Fretay, Farzin Beygui, Jean-Louis Bonnet, Benoit Lattuca, Christophe Pouillot, Olivier Varenne, Ziad Boueri, Eric Van Belle, Patrick Henry, Pascal Motreff, Simon Elhadad, Joe-Elie Salem, Jérémie Abtan, Hélène Rousseau, Jean-Philippe Collet, Eric Vicaut, Gilles Montalescot, ANTARCTIC investigators
    Publicated in The Lancet
  • Platelet function monitoring in elderly patients on prasugrel after stenting for an acute coronary syndrome : design of the randomized ANTARCTIC study
    Guillaume Cayla, Thomas Cuisset, Johanne Silvain, Patrick Henry, Florence Leclercq, Didier Carrié, Christophe Saint Etienne, Loic Belle, Grégoire Rangé, Christophe Pouillot, Olivier Varenne, Eric Van Belle, Ziad Boueri, Pascal Motreff, Simon Elhadad, Nicolas Delarche, Rami El Mahmoud, Eric Vicaut, Jean-Philippe Collet, Gilles Montalescot, ANTARCTIC investigators
    Publicated in American Heart Journal

Presentations

  • ESC2018 - Poster 'Impact and predictive factors of bleeding complications in elderly patients, insights from ANTARCTIC'
    pdf
  • ESC2018 - Poster 'Platelet function monitoring, pooled analysis of ARCTIC and ANTARCTIC'
    pdf
  • ESC2018 - Presentation 'Impact and predictive factors of bleeding complications in elderly patients, insights from ANTARCTIC'
    pdf
  • ESC2016 - HotLine, presentation ANTARCTIC
    powerpoint
  • ESC2016 - Press release APHP / ACTION
    pdf

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