@article{3171876,
    title = "Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A
12-Month Randomized Clinical Trial",
    author = "Ntalas, Ioannis V. and Kalantzi, Kallirroi I. and Tsoumani, Maria E. and and Bourdakis, Adamantios and Charmpas, Christos and Christogiannis, and Zaharias and Dimoulis, Nikolaos and Draganigos, Antonios and and Efthimiadis, Ioannis and Giannakoulas, Giorgos and Giatrakos, Ioannis and and Giogiakas, Vassilios and Goumas, Giorgos and Hatziathanasiou, and Giorgos and Kazakos, Evangelos and Kipouridis, Nikolaos and and Konstantinou, Spiros and Milionis, Haralampos and Nikolopoulos, and Dimitrios and Peltekis, Leonidas and Prokopakis, Nikolaos and Sinteles, and Ioannis and Stroumbis, Christos and Terzoudi, Kyriafina and Thoma, Maria and and Tsilias, Karmelos and Vakalis, Ioannis and Vardakis, Konstantinos and and Vasilakopoulos, Vasileios and Vemmos, Konstantinos and Voukelatou, and Maria and Xaraktsis, Ioannis and Panagiotakos, Demosthenes B. and and Goudevenos, John A. and Tselepis, Alexandros D.",
    journal = "Journal of Cardiovascular Pharmacology and Therapeutics",
    year = "2016",
    volume = "21",
    number = "6",
    pages = "516-525",
    publisher = "SAGE Publications Inc.",
    issn = "1074-2484, 1940-4034",
    doi = "10.1177/1074248416644343",
    keywords = "clopidogrel besylate; coronary artery disease; generic clopidogrel;
peripheral artery disease; carotid artery disease; stroke",
    abstract = "Background: In the present clinical trial, we compared the efficacy and
safety of the generic clopidogrel besylate (CB) with the innovator
clopidogrel hydrogen sulfate (CHS) salt in patients eligible to receive
clopidogrel. Methods: A prospective 2-arm, multicenter, open-label,
phase 4 clinical trial. Consecutive patients (n = 1864) were screened
and 1800 were enrolled in the trial and randomized to CHS or CB. 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
criteria. Results: At 12-month follow-up, no differences were observed
between CB (n = 759) and CHS (n = 798) in primary efficacy and safety
end points (age, sex, history of percutaneous coronary intervention
adjusted odds ratio [OR], 0.70; 95% confidence interval [CI],
0.41-1.21 and OR, 0.81; 95% CI, 0.51-1.29, respectively) between CHS
and CB. Analyses of efficacy and safety in subgroups that were defined
according to the qualifying diagnosis revealed that there was no
difference between CHS and CB. Conclusion: The efficacy and safety of CB
administered for 12 months for the secondary prevention of
atherothrombotic events are similar to that of CHS."
}