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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00822536.
authors: bd Vincent Auriol, Institut de Cardiologie, Hôpital Pitié-Salpétrière, Paris, France. gerard.helft@psl.aphp.fr
authors: Gérard
authors: G
authors: Helft
authors: Claude
authors: C
authors: Le Feuvre
authors: Jean Louis
authors: JL
authors: Georges
authors: Didier
authors: D
authors: Carrie
authors: Florence
authors: F
authors: Leclercq
authors: Hélène
authors: H
authors: Eltchaninoff
authors: Alain
authors: A
authors: Furber
authors: Fabrice
authors: F
authors: Prunier
authors: Laurent
authors: L
authors: Sebagh
authors: Simon
authors: S
authors: Cattan
authors: Guillaume
authors: G
authors: Cayla
authors: Eric
authors: E
authors: Vicaut
authors: Jean-Philippe
authors: JP
authors: Metzger
mesh_terms: D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D000077144:Clopidogrel; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005602:France; D006470:Hemorrhage / Q000139:chemically induced / Q000401:mortality; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011474:Prosthesis Design; D012107:Research Design; D020521:Stroke / Q000209:etiology / Q000401:mortality; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin