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IRCT138712111723N1 IRCT 2009-06-20 Osve Pharmacology Institute Osvix versus Plavix in cardiovascular event after coronary stenting OPCES Osvix versus Plavix in cardiovascular event after coronary stenting 2007-03-10 anticipated 450 Complete https://irct.ir/trial/1225 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A cardiovascular event after coronary stenting. Intervention 1: Osvix 6 tablets before PCI, continue with 1 tablet daily after PCI For 1 month in Bare metal stent. Intervention 2: Plavix 6 tablets before PCI, continue with 1 tablet daily after PCI For 1 month in Bare metal stent. Intervention 3: Osvix 6 tablets before PCI, continue with 1 tablet daily after PCI For 1 month in Bare metal stent. Intervention 4: Plavix 6 tablets before PCI, continue with 1 tablet daily after PCI For 6 months in Drug eluting stent.
public Dr. Alireza Khosravi
Cardiovascular Research Center, Khoram ave., Darvaze tehran
Isfahan Iran (Islamic Republic of) 0098311-3373435 +98 31 1335 9090 alikh108@yahoo.com Cardiovascular Research Center, Isfahan University of Medical Sciences scientific Dr. Alireza Khosravi
Isfahan, Cardiovascular Research Center, Khorram ave, Darvaz tehran
Isfahan Iran (Islamic Republic of) 814651148 +98 31 1335 9090 alikh108@yahoo.com Cardiovascular Research Center, Isfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Stents with diameter ≥2.5 mm approved by ministry of health in Iran, no evidence of significant thrombus in Angiography before stenting, presence of necessary cooperation for follow up Exclusion criteria: Previously taken Plavix, Ticlopidin, Warfarin or Osvix for other reasons, Co-morbid diseases with predicted survival less than 6 months, primary PCI for ST elevation MI, LVEF< 30%, Stent in vein grafts or LIMA, patients that need GP IIb IIIa blocker before or after stenting, history of allergy to Plavix or Osvix, any contraindication to Plavix or Osvix (liver dysfunction, thrombocytopenia, notropenia), complete vessel occlusion without clinical symptom of viability (infarct vessel), cardiogenic shock, need to mechanical hemodynamic support like Intra-aortic balloon pump using rotablator, thrombectomy, using vascular brachytherapy or DCA during procedure, Stenting of unprotected left main coronary artery, prior enrolment in OPCES trial In following patients, study drug must be stopped and unblended drug will Prescribe for them. a. Patients with early post PCI angina with evidence of ischemia or infarction at ECG or lab exam b. undergoing target vessel revascularization ( CABG, PCI ) c. Residual dissection after PCI or coronary artery perforation d. Thrombosis in vessel after stenting no limit no limit Both I20-I21-I2 Angina pectoris - Acute myocardial infarction - Other acute ischaemic heart diseases Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Osvix 6 tablets before PCI, continue with 1 tablet daily after PCI For 1 month in Bare metal stent Plavix 6 tablets before PCI, continue with 1 tablet daily after PCI For 1 month in Bare metal stent Osvix 6 tablets before PCI, continue with 1 tablet daily after PCI For 1 month in Bare metal stent Plavix 6 tablets before PCI, continue with 1 tablet daily after PCI For 6 months in Drug eluting stent Incidence of cardiovascular event. Timepoint: Every day during the first week, then every week for 6 months or 1 year. Method of measurement: phone follow up or visit. Hematological or dermatological complication. Timepoint: Every day during the first week and every week for 6 months or 1 year. Method of measurement: visit and labratoary tests. Osve Pharmacology Institute Approved Isfahan Cardiovascular Research Center Sedighe tahere Cardiovascular Research Center-khoram ave. Darvaze Tehran-Isfahan Isfahan Iran (Islamic Republic of)