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Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial

Authors: Gérard Helft, Claude Le Feuvre, Jean Louis Georges, Didier Carrie, Florence Leclercq, Hélène Eltchaninoff, Alain Furber, Fabrice Prunier, Laurent Sebagh, Simon Cattan, Guillaume Cayla, Eric Vicaut, Jean-Philippe Metzger

Published in: Trials | Issue 1/2013

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Abstract

Background

Dual antiplatelet therapy with aspirin and thienopyridine is required after placement of coronary drug-eluting stents (DES) to prevent thrombotic complications. Current clinical guidelines recommend at least 6 to 12 months of treatment after a DES implantation, but it may be beneficial to apply dual antiplatelet therapy for a longer duration.

Methods/design

The optimal dual antiplatelet therapy (OPTIDUAL) study aims to compare the benefits and risks of dual antiplatelet therapy applied for either 12 or 48 months. We will examine the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention with DES for the treatment of coronary lesions. The OPTIDUAL study is an open-label multicenter, randomized, national trial that will include 1,966 patients treated with DES. All patients will be treated with dual antiplatelet therapy for 12 months (+/− 3). Then, patients with no MACCE or major bleeding will be randomized to receive either 36 additional months of clopidogrel plus aspirin or aspirin only. The primary end-point is the combination of death from all causes, myocardial infarction, stroke and major bleeding. The secondary end points include the individual components of the primary end-point, stent thrombosis, repeat revascularization of the treated vessel and minor bleeding.

Discussion

This randomized trial is designed to assess the benefits and safety of 12 versus 48 months of dual antiplatelet therapy in patients that receive a DES. We aim to determine whether substantial prolongation of clopidogrel (a thienopyridine) after DES implantation offers an advantage over its discontinuation.

Trial registration

ClinicalTrials.gov Identifier: NCT00822536
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Metadata
Title
Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial
Authors
Gérard Helft
Claude Le Feuvre
Jean Louis Georges
Didier Carrie
Florence Leclercq
Hélène Eltchaninoff
Alain Furber
Fabrice Prunier
Laurent Sebagh
Simon Cattan
Guillaume Cayla
Eric Vicaut
Jean-Philippe Metzger
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-56

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