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The Impact of Generic Form of Clopidogrel on Cardiovascular Events in Patients With Coronary Artery Stent: Results of the Opces Study



Khosravi AR1, 5 ; Pourmoqhadas M2 ; Ostovan M3 ; Mehr GK2 ; Gharipour M2 ; Zakeri H4 ; Soleimani B1 ; Namdari M6 ; Hassanzadeh M7 ; Tavasolli AA2 ; Ghaffari S8 ; Khaledifar A9 ; Roghani F1 ; Khosravi MR8 Show All Authors
Authors
  1. Khosravi AR1, 5
  2. Pourmoqhadas M2
  3. Ostovan M3
  4. Mehr GK2
  5. Gharipour M2
  6. Zakeri H4
  7. Soleimani B1
  8. Namdari M6
  9. Hassanzadeh M7
  10. Tavasolli AA2
  11. Ghaffari S8
  12. Khaledifar A9
  13. Roghani F1
  14. Khosravi MR8
  15. Sarami S10
  16. Kojouri J1
  17. Nori F2
  18. Khosravi E1
  19. Jozan M1
  20. Sarrafzadegan N2
Show Affiliations
Authors Affiliations
  1. 1. Isfahan Hypertension Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
  2. 2. Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
  3. 3. Shiraz University of Medical Sciences, Shiraz, Iran
  4. 4. Fasa University of Medical Sciences, Fasa, Iran
  5. 5. School of Medicine, Najafabad Branch, Islamic Azad University, Isfahan, Iran
  6. 6. Lorestan University of Medical Sciences, Khoramabad, Iran
  7. 7. Mashhad University of Medical Sciences, Mashad, Iran
  8. 8. Tabriz University of Medical Sciences, Tabriz, Iran
  9. 9. Shahrekord University of Medical Sciences, Shahrekord, Iran
  10. 10. Department of Pharmaceutics, School of Pharmacology, Tehran University of Medical Sciences, Tehran, Iran

Source: Journal of Research in Medical Sciences Published:2011

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.
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