1. Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial.
- Author
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Ntalas IV, Kalantzi KI, Tsoumani ME, Bourdakis A, Charmpas C, Christogiannis Z, Dimoulis N, Draganigos A, Efthimiadis I, Giannakoulas G, Giatrakos I, Giogiakas V, Goumas G, Hatziathanasiou G, Kazakos E, Kipouridis N, Konstantinou S, Milionis H, Nikolopoulos D, Peltekis L, Prokopakis N, Sinteles I, Stroumbis C, Terzoudi K, Thoma M, Tsilias K, Vakalis I, Vardakis K, Vasilakopoulos V, Vemmos K, Voukelatou M, Xaraktsis I, Panagiotakos DB, Goudevenos JA, and Tselepis AD
- Subjects
- Aged, Aged, 80 and over, Cardiovascular Diseases diagnosis, Cardiovascular Diseases mortality, Clopidogrel, Drug Compounding, Drugs, Generic adverse effects, Drugs, Generic chemistry, Female, Greece, Hemorrhage chemically induced, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction etiology, Odds Ratio, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors adverse effects, Platelet Aggregation Inhibitors chemistry, Prospective Studies, Risk Factors, Stroke etiology, Therapeutic Equivalency, Ticlopidine adverse effects, Ticlopidine chemistry, Ticlopidine therapeutic use, Time Factors, Treatment Outcome, Cardiovascular Diseases drug therapy, Drugs, Generic therapeutic use, Platelet Aggregation Inhibitors therapeutic use, Secondary Prevention methods, Ticlopidine analogs & derivatives
- 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. (Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence, SCIENCE trial; ClinicalTrials.gov Identifier:NCT02126982)., (© The Author(s) 2016.)
- Published
- 2016
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