cardiovascular event after coronary stenting. Angina pectoris - Acute myocardial infarction - Other acute ischaemic heart diseases
Conditions
Interventions
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
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
Plavix 6 tablets before PCI, continue with 1 tablet daily after PCI For 6 months in Drug eluting stent
Sponsors
Osve Pharmacology Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Alireza Khosravi
Cardiovascular Research Center, Isfahan University of Medical Sciences
Outcome results
None listed