title: Generic Clopidogrel Besylate in the Secondary Prevention of Atherothrombotic Events: A 6-month Follow-up of a Randomised Clinical Trial.
abstract: BACKGROUND
  The aim of the present interim analysis was to compare the clinical efficacy and safety of the generic clopidogrel besylate (CB) with the innovator clopidogrel hydrogen sulphate (CHS) salt in patient groups eligible to receive clopidogrel.
  
  
  METHODS
  A 2-arm, multicenter, open-label, phase 4 clinical trial. Consecutive patients (n=1,864) were screened and 1,800 were enrolled in the trial and randomized to CHS (n=759) or CB (n=798). Primary efficacy end point was the composite of myocardial infarction, stroke or death from vascular causes, and primary safety end point was rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria.
  
  
  RESULTS
  At 6-months follow-up no differences were observed between CB and CHS in primary efficacy end point (OR, 0.80; 95% CI, 0.37 to 1.71; p=0.57). Rates of BARC-1,-2,-3a and -5b bleeding were similar between the two study groups whereas no bleeding events according to BARC-3b, -3c, -4 and -5a were observed in either CHS or CB group.
  
  
  CONCLUSIONS
  The clinical efficacy and safety of the generic CB is similar to that of the innovator CHS salt, thus, it can be routinely used in the secondary prevention of atherothrombotic events for a period of at least 6 months. (Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence, SCIENCE study Clinical Trials.gov Identifier: NCT02126982).
authors.forename: Ioannis V
authors.initials: IV
authors.lastname: Ntalas
authors.forename: Kalliroi I
authors.initials: KI
authors.lastname: Kalantzi
authors.forename: Maria E
authors.initials: ME
authors.lastname: Tsoumani
authors.forename: John N
authors.initials: JN
authors.lastname: Vakalis
authors.forename: Vasileios
authors.initials: V
authors.lastname: Vasilakopoulos
authors.forename: Konstantinos
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authors.lastname: Vardakis
authors.forename: Konstantinos N
authors.initials: KN
authors.lastname: Vemmos
authors.forename: Maria
authors.initials: M
authors.lastname: Voukelatou
authors.forename: Georgios
authors.initials: G
authors.lastname: Giannakoulas
authors.forename: Ioannis
authors.initials: I
authors.lastname: Giatrakos
authors.forename: Vasileios
authors.initials: V
authors.lastname: Giogiakas
authors.forename: Georgios
authors.initials: G
authors.lastname: Goumas
authors.forename: Nikos
authors.initials: N
authors.lastname: Dimoulis
authors.forename: Antonios
authors.initials: A
authors.lastname: Draganigos
authors.forename: Ioannis
authors.initials: I
authors.lastname: Efthimiadis
authors.forename: Maria
authors.initials: M
authors.lastname: Thoma
authors.forename: Evangelos
authors.initials: E
authors.lastname: Kazakos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Kipouridis
authors.forename: Spiros
authors.initials: S
authors.lastname: Konstantinou
authors.forename: Adamantios
authors.initials: A
authors.lastname: Bourdakis
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Nikolopoulos
authors.forename: Leonidas
authors.initials: L
authors.lastname: Peltekis
authors.forename: Nikos
authors.initials: N
authors.lastname: Prokopakis
authors.forename: Ioannis
authors.initials: I
authors.lastname: Sinteles
authors.forename: Christos S
authors.initials: CS
authors.lastname: Stroumbis
authors.forename: Kyriafina
authors.initials: K
authors.lastname: Terzoudi
authors.forename: Karmelos
authors.initials: K
authors.lastname: Tsilias
authors.forename: Ioannis
authors.initials: I
authors.lastname: Xaraktsis
authors.forename: Christos
authors.initials: C
authors.lastname: Charmpas
authors.forename: Georgios
authors.initials: G
authors.lastname: Hatziathanasiou
authors.forename: Zacharias
authors.initials: Z
authors.lastname: Christogiannis
authors.forename: Demosthenes B
authors.initials: DB
authors.lastname: Panagiotakos
authors.forename: John A
authors.initials: JA
authors.lastname: Goudevenos
authors.affiliation: Atherothrombosis Research Centre, Department of Chemistry, University of Ioannina, 45110 Ioannina, Greece. atselep@uoi.gr.
authors.forename: Alexandros D
authors.initials: AD
authors.lastname: Tselepis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000077144:Clopidogrel; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D055502:Secondary Prevention / Q000379:methods; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control*; D013927:Thrombosis / Q000517:prevention & control; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D016568:Drugs, Generic; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine