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
