This study is designed to evaluate the clinical effect of Osvix versus Plavix in preventing cardiovascular events after coronary stenting, so if Osvix shows the positive effect, we can replace Plavix with Osvix. Our sample size was 450 and the study duration was approximately 2 years. Our studied population is patients who are referred to hospital for coronary stenting. Patients were divided into two groups: 1. bare metal stent (BMS) 2. Drug eluting stent (DES) and each of these groups were divided into two groups: receiving Osvix or Plavix double-blindly. After evaluating inclusion and exclusion criteria, all the information are entered in special forms. Patients with bare metal stent were treated by study drug for 1 month and patients with drug eluting stent are treated by study drug for 6 months. All patients after hospital discharge were followed for 6 months in BMS and 1 year in DES by phone, regularly. Patients with BMS were visited at the end of first month and DES at the end of first and sixth month. During this period, we evaluated cardiovascular events (like in-stent thrombosis, myocardial infarction, stroke …)
General information
Acronym
OPCES
IRCT registration information
IRCT registration number:IRCT138712111723N1
Registration date:2009-06-20, 1388/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-06-20, 1388/03/30
Registrant information
Name
Alireza Khosravi
Name of organization / entity
Isfahan Cardiovascular Research Center
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9090
Email address
crc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Osve Pharmacological Institution
Expected recruitment start date
2007-03-10, 1385/12/19
Expected recruitment end date
2009-03-19, 1387/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Osvix versus Plavix in cardiovascular event after coronary stenting
Public title
Osvix versus Plavix in cardiovascular event after coronary stenting
Purpose
Treatment
Inclusion/Exclusion 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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
450
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Cardiovascular Research Center
Street address
Sedighe tahere Cardiovascular Research Center-khoram ave. Darvaze Tehran-Isfahan