Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial.
| Title | Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial. |
| Publication Type | Journal Article |
| Year of Publication | 2016 |
| Authors | Ntalas, I. V., Kalantzi K. I., Tsoumani M. E., 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 D. B., Goudevenos J. A., & Tselepis A. D. |
| Journal | J Cardiovasc Pharmacol Ther |
| Volume | 21 |
| Issue | 6 |
| Pagination | 516-525 |
| Date Published | 2016 11 |
| ISSN | 1940-4034 |
| Keywords | Aged, Aged, 80 and over, Cardiovascular Diseases, Drug Compounding, Drugs, Generic, Female, Greece, Hemorrhage, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction, Odds Ratio, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Prospective Studies, Risk Factors, Secondary Prevention, Stroke, Therapeutic Equivalency, Ticlopidine, Time Factors, Treatment Outcome |
| 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). |
| DOI | 10.1177/1074248416644343 |
| Alternate Journal | J. Cardiovasc. Pharmacol. Ther. |
| PubMed ID | 27081185 |
