| Autor: |
Ntalas, Ioannis V. Kalantzi, Kalliroi I. Tsoumani, Maria E. and Vakalis, John N. Vasilakopoulos, Vasileios Vardakis, Konstantinos Vemmos, Konstantinos N. Voukelatou, Maria and Giannakoulas, Georgios Giatrakos, Ioannis Giogiakas, Vasileios and Goumas, Georgios Dimoulis, Nikos Draganigos, Antonios and Efthimiadis, Ioannis Thoma, Maria Kazakos, Evangelos and Kipouridis, Nikolaos Konstantinou, Spiros Milionis, Haralampos and Bourdakis, Adamantios Nikolopoulos, Dimitrios Peltekis, Leonidas Prokopakis, Nikos Sinteles, Ioannis Stroumbis, Christos S. Terzoudi, Kyriafina Tsilias, Karmelos Xaraktsis, Ioannis Charmpas, Christos Hatziathanasiou, Georgios and Christogiannis, Zacharias Panagiotakos, Demosthenes B. and Goudevenos, John A. Tselepis, Alexandros D. |
| Jazyk: |
angličtina |
| Rok vydání: |
2015 |
| ISSN: |
0212-6982 |
| Popis: |
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 IV 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. Primary safety end point was the 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 were similar to those of the innovator CHS salt, thus this generic clopidogrel formulation 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). |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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