The impact of generic form of Clopidogrel on cardiovascular events in patients with coronary artery stent: results of the OPCES study

Khosravi, Alireza. and Pourmoghadas, Masoud. and Ostovan, Mohammad. and Kiani Mehr, Gilda. and Gharipour, Mojgan. and Zakeri, Habib. and Soleimani, Bahram. and Namdari, Mehrdad. and Hassanzadeh, Mehdi. and Tavassoli, AliAkbar. and Ghaffari, Samad. and Khaledifar, Arsalan. and Roghani, Farshad. and Khosravi, MohammadReza. and Sarami, Shahrooz. and Kojouri, Javad. and Nori, Fatemeh. and Khosravi, Elham. and Jozan, Mahnaz. and Sarrafzadegan, Nizal. (2011) The impact of generic form of Clopidogrel on cardiovascular events in patients with coronary artery stent: results of the OPCES study. JOURNAL OF RESEARCH IN MEDICAL SCIENCES, 16 (5). pp. 640-650.

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Abstract

BACKGROUND: To compare the early and late cardiovascular events as well as side effects of Osvix, a generic form of Clopidogrel versus Plavix regimens in patients with chronic stable angina, undergoing bare metal stent (BMS) or drug eluting stent (DES) placement, this study was carried out. METHODS: A total of 442 patients with chronic stable angina who were scheduled for elective percutaneous coronary intervention (PCI) were included in a randomized, double blind, multi-centric clinical trial being performed in 6 distinct university hospitals in 5 cities of Iran from March 2007 to November 2009. Baseline, demographic and history of risk factors were recorded using the patients' medical charts. Stenting procedure was performed via transfemoral approach using low osmolar contrast agents. Patients underwent BMS or DES placements based on the physician selection and were randomly assigned to Osvix or Plavix groups. Patients were followed by telephone in 0 and 6 months intervals regarding the major adverse cardiovascular events (MACE) including death, myocardial infarction, in-stent thrombosis, stroke, target lesion revascularization, and target vascular revascularization. Angina episodes, bleeding, liver enzymes, neutrophils and platelets count were also assessed in these intervals. RESULTS: There was not any significant difference between these two groups regarding the baseline characteristics. In the DES group, the 6-month mortality rate and the incidence of MACE in Osvix and Plavix groups were 0.9% and 1.9% (p = 0.61) and 1.8% and 4.9% (p = 0.26), respectively. During the follow up period after DES or BMS placement, there wasn't any significant difference regarding neutrophil and platelet counts or liver enzymes between study groups. CONCLUSIONS: Using Osvix and Plavix are followed by similar major cardiovascular events and side-effect profile in patients undergoing PCI.

Item Type: Article
Uncontrolled Keywords: Cardiovascular Events; Coronary Artery Stents; OPCES
Subjects: WG Cardiovascular System
QV pharmacology > QV 704 Pharmaceutics
Divisions: Faculty of Medicine > Department of Clinical Sciences > Department of Cardiology
Depositing User: Users 1 not found.
Date Deposited: 16 Aug 2017 04:45
Last Modified: 17 Apr 2018 09:14
URI: http://eprints.skums.ac.ir/id/eprint/3101

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