title: The impact of generic form of Clopidogrel on cardiovascular events in patients with coronary artery stent: results of the OPCES study.
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.
authors.affiliation: Isfahan Hypertension Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Ali Reza
authors.initials: AR
authors.lastname: Khosravi
authors.forename: Masoud
authors.initials: M
authors.lastname: Pourmoghadas
authors.forename: Mohammad
authors.initials: M
authors.lastname: Ostovan
authors.forename: Gilda Kiani
authors.initials: GK
authors.lastname: Mehr
authors.forename: Mojgan
authors.initials: M
authors.lastname: Gharipour
authors.forename: Habib
authors.initials: H
authors.lastname: Zakeri
authors.forename: Bahram
authors.initials: B
authors.lastname: Soleimani
authors.forename: Mehrdad
authors.initials: M
authors.lastname: Namdari
authors.forename: Mehdi
authors.initials: M
authors.lastname: Hassanzadeh
authors.forename: Ali Akbar
authors.initials: AA
authors.lastname: Tavassoli
authors.forename: Samad
authors.initials: S
authors.lastname: Ghaffari
authors.forename: Arsalan
authors.initials: A
authors.lastname: Khaledifar
authors.forename: Farshad
authors.initials: F
authors.lastname: Roghani
authors.forename: Mohammad Reza
authors.initials: MR
authors.lastname: Khosravi
authors.forename: Shahrooz
authors.initials: S
authors.lastname: Sarami
authors.forename: Javad
authors.initials: J
authors.lastname: Kojouri
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Nori
authors.forename: Elham
authors.initials: E
authors.lastname: Khosravi
authors.forename: Mahnaz
authors.initials: M
authors.lastname: Jozan
authors.forename: Nizal
authors.initials: N
authors.lastname: Sarrafzadegan
references.citation: JAMA. 2005 May 4;293(17):2126-30
references.pmid: 15870416
references.citation: Circulation. 2004 Dec 21;110(25):3773-80
references.pmid: 15596568
references.citation: Mayo Clin Proc. 2006 May;81(5):641-52
references.pmid: 16706262
references.citation: N Engl J Med. 1985 Apr 4;312(14):932-6
references.pmid: 4038784
references.citation: Lancet. 1996 Nov 16;348(9038):1329-39
references.pmid: 8918275
references.citation: Circulation. 2007 May 1;115(17):2344-51
references.pmid: 17470709
references.citation: JAMA. 2007 Jan 10;297(2):159-68
references.pmid: 17148711
references.citation: Am Heart J. 1999 Aug;138(2 Pt 2):S48-54
references.pmid: 10426859
references.citation: JAMA. 2002 Nov 20;288(19):2411-20
references.pmid: 12435254
references.citation: Acta Cardiol. 1999 Oct;54(5):257-63
references.pmid: 10596304
references.citation: Catheter Cardiovasc Interv. 2007 Feb 15;69(3):334-40
references.pmid: 17295287
references.citation: Curr Opin Cardiol. 2007 Jul;22(4):273-9
references.pmid: 17556877
references.citation: Neth Heart J. 2007;15(4):148-50
references.pmid: 17612675
references.citation: J Korean Med Sci. 2009 Oct;24(5):800-6
references.pmid: 19794974
references.citation: N Engl J Med. 2001 Aug 16;345(7):494-502
references.pmid: 11519503
references.citation: N Engl J Med. 2006 Apr 20;354(16):1706-17
references.pmid: 16531616
references.citation: Biomed Chromatogr. 2006 Dec;20(12):1309-14
references.pmid: 16977589
references.citation: Circulation. 1999 May 11;99(18):2364-6
references.pmid: 10318654
references.citation: BMJ. 1994 Jan 8;308(6921):81-106
references.pmid: 8298418
references.citation: N Engl J Med. 1998 Dec 3;339(23):1665-71
references.pmid: 9834303
references.citation: J Am Coll Cardiol. 2004 Jul 21;44(2):357-61
references.pmid: 15261931
references.citation: Circulation. 2000 Aug 8;102(6):624-9
references.pmid: 10931801
references.citation: Lancet. 2001 Aug 18;358(9281):527-33
references.pmid: 11520521
references.citation: Indian Heart J. 2008 Jul-Aug;60(4):318-24
references.pmid: 19242009