Generic Clopidogrel Besylate in the Secondary Prevention of Atherothrombotic Events: A 6-month Follow-up of a Randomised Clinical Trial

Ntalas, Ioannis; Kalantzi, Kalliroi I.; Tsoumani, Maria; Vakalis, J N; Vasilakopoulos, Vasileios; Vardakis, Konstantinos E.; Vemmos, Konstantinos; Voukelatou, Maria; Giannakoulas, George; Giatrakos, Ioannis; Giogiakas, Vasileios; Goumas, G.; Dimoulis, Nikos; Draganigos, Antonios; Efthimiadis, I.; Thoma, Maria; Kazakos, Evangelos; Kipouridis, Nikolaos; Konstantinou, Spiros; Milionis, Haralampos; Bourdakis, Adamantios; Nikolopoulos, Dimitrios; Peltekis, Leonidas; Prokopakis, Nikos; Sinteles, Ioannis; Stroumbis, Christos S.; Terzoudi, Kyriafina; Tsilias, Karmelos; Xaraktsis, Ioannis; Charmpas, Christos; Hatziathanasiou, Georgios; Christogiannis, Zacharias; Panagiotakos, Demosthenes B.; Goudevenos, John; Tselepis, Alexandros D.

doi:10.2174/1570161113666150316220515

Cited by 4 publications

(7 citation statements)

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“…The SCIENCE was a prospective 2-arm, multicenter (9 centers), open-label, phase 4 clinical trial, designed to compare the short (6-month) and long (12-month) efficacy and safety of CB versus CHS in reducing atherothrombotic events in several types of patients eligible to receive clopidogrel. 21…”

Section: Methodsmentioning

confidence: 99%

“…The qualifying diagnosis of each disorder and the inclusion and exclusion criteria have been reported previously. 21…”

Section: Methodsmentioning

confidence: 99%

“…We screened 1864 consecutive patients in order to participate in the trial. 21 During screening, 4 patients were excluded because they did not meet the inclusion criteria, whereas 60 patients declined to participate since the procedure of participation had been explained. Thus, 1800 patients were randomized.…”

Section: Methodsmentioning

confidence: 99%

“…The interim analysis of this trial performed at 6 months of follow-up demonstrated that both clopidogrel salts were similar as regards the clinical efficacy and safety end points. 21…”

Section: Introductionmentioning

confidence: 99%

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Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial

Ntalas

Kalantzi

Tsoumani

et al. 2016

J Cardiovasc Pharmacol Ther

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Section: Methodsmentioning

confidence: 99%

“…The qualifying diagnosis of each disorder and the inclusion and exclusion criteria have been reported previously. 21…”

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…The interim analysis of this trial performed at 6 months of follow-up demonstrated that both clopidogrel salts were similar as regards the clinical efficacy and safety end points. 21…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial

Ntalas

Kalantzi

Tsoumani

et al. 2016

J Cardiovasc Pharmacol Ther

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“…In the interim analysis of the very recent SCIENCE (Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence) trial we observed low bleeding events at 6 month follow-up in patients treated with either clopidogrel besylate or clopidogrel hydrogen sulfate (BARC 3a; 0.3% for both drugs, p ¼ 0.93, and BARC 5b; 0.1% for both drugs, p ¼ 0.91) 28 . The present results are consistent with a previous published study in Korean patients after coronary stent implantation.…”

mentioning

confidence: 91%

Evaluating the bioequivalence of clopidogrel generic formulations

Tsoumani

Ntalas

Goudevenos

et al. 2015

Current Medical Research and Opinion

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Comparison of 4 different strategies of DAPT after PCI in ACS real world population from a Northern Italy registry

Rasia¹,

Solinas²,

Marino

et al. 2017

J Thromb Thrombolysis

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Aim of the study was to compare four different strategies of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) treated with PCI. DAPT with Clopidogrel, Ticagrelor and Prasugrel has proved to be effective in patients with ACS treated with percutaneous coronary intervention (PCI) by reducing major adverse cardiovascular outcomes (MACE). However, the effect of the different strategies in a real-world population deserves further verification. A retrospective analysis of 2404 discharged ACS patients treated with PCI was performed, with a median follow-up of 1 year. The study population was stratified in four drug treatment cohorts: ASA + Clopidogrel (A-C), ASA + Plavix (A-PLx), ASA + Ticagrelor (A-T), ASA + Prasugrel (A-P). We assessed the incidence of net adverse cardiovascular events (NACE): all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stroke and bleeding during follow-up. At 1-year, the use of A-C and A-PLx was associated with the highest cumulative incidence of NACE in comparison with A-T and A-P therapies (respectively 14.8 and 29.6% vs. 9.2 and 6%). This difference was mainly driven by the mortality and TVR outcomes. Considering selection bias and differences in the patients baseline characteristics, the association of A-T and A-P seems to be superior in comparison with a DAPT strategy of A-C and A-PLx in low risk ACS-PCI patients from real world. In our Region the prescription is consistent with guidelines recommendations and Clopidogrel and Plavix are still predominantly used in older patients with more comorbidities, and this could partially explain the inferiority of this association.

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Generic Clopidogrel Besylate in the Secondary Prevention of Atherothrombotic Events: A 6-month Follow-up of a Randomised Clinical Trial

Cited by 4 publications

References 0 publications

Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial

Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial

Evaluating the bioequivalence of clopidogrel generic formulations

Comparison of 4 different strategies of DAPT after PCI in ACS real world population from a Northern Italy registry

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