Ioannis V. Ntalas, Kalliroi I. Kalantzi, Maria E. Tsoumani, John N. Vakalis, Vasileios Vasilakopoulos, Konstantinos Vardakis, Konstantinos N. Vemmos, Maria Voukelatou, Georgios Giannakoulas, Ioannis Giatrakos, Vasileios Giogiakas, Georgios Goumas, Nikos Dimoulis, Antonios Draganigos, Ioannis Efthimiadis, Maria Thoma, Evangelos Kazakos, Nikolaos Kipouridis, Spiros Konstantinou, Haralampos Milionis, Adamantios Bourdakis, Dimitrios Nikolopoulos, Leonidas Peltekis, Nikos Prokopakis, Ioannis Sinteles, Christos S. Stroumbis, Kyriafina Terzoudi, Karmelos Tsilias, Ioannis Xaraktsis, Christos Charmpas, Georgios Hatziathanasiou, Zacharias Christogiannis, Demosthenes B. Panagiotakos, John A. Goudevenos and Alexandros D. Tselepis Pages 809 - 818 ( 10 )
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.
Conclusion: 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).
Acute coronary syndrome, clinical efficacy, clopidogrel besylate, coronary artery disease, generic clopidogrel, peripheral artery disease, stroke.
Atherothrombosis Research Centre, Department of Chemistry, University of Ioannina, 45110 Ioannina, Greece.