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IRCT138710101525N1 IRCT 2009-12-20 Vice-chanceller for Research Affairs, Shiraz University of Medical Sciences Safety of Enoxaparin versus unfractioned heparin in patients undergoing percutaneous coronary intervention using drug eluting stents: A pilot study Incidence of clinical sign and symptom of acute ischemia and vascular complication with Enoxaparin during stenting in comparison with heparin 2004-10-31 anticipated 200 Complete https://irct.ir/trial/806 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 3 Coronary Artery Disease. Intervention 1: An intravenous bolus of 10000 IU unfractionated heparin, adjusted for activated clotting time according to current guidelines. Intervention 2: Intravenous Enoxaparin at a dose of 0.75 mg per kilogram during the procedure.
public Zahra Daneshvar
Faghihi Hospital, Zand ave. Shiraz, Iran
Shiraz Iran (Islamic Republic of) zdaneshvar@gmail.com Cardiovascular Research Center, Shiraz University of Medical Sciences scientific Mohammad Javad Zibaeenezhad
Faghihi hospital, Zand ave. Shiraz, Iran
Shiraz Iran (Islamic Republic of) zibaeem2@sums.ac.ir Cardiovascular Research Center Iran (Islamic Republic of) Inclusion criteria: Patients with atherosclerotic coronary artery disease (chronic stable angina or acute coronary syndromes) were included if they were candidate for PCI as a result of uncontrolled anginal pain, unresponsive to the maximum dose of nitrates or incidence of adverse drug reactions in which it was impossible to continue medical treatment, Patients with clinical sign of heart failure and ischemic involvement of a relatively large segment of myocardium Exclusion criteria: Age 75 years or older, presence of renal failure defined as creatinine clearance of 30 ml/min and over,creatinine≥2.5 mg/dl in male and creatinine≥2.0 mg/dl in female participants, use of bare-metal stents, presence of primary PCI, receiving heparin or LMWH before randomization, unacceptable prothrombin time (PT) or platelet count, presence of platelet functional disorders or coagulopathies, or hypercoagulopathy syndromes. no limit no limit Both I25 Chronic ischaemic heart disease Prevention Prevention An intravenous bolus of 10000 IU unfractionated heparin, adjusted for activated clotting time according to current guidelines Intravenous Enoxaparin at a dose of 0.75 mg per kilogram during the procedure The incidence of major bleedings. Timepoint: during the first 24 hours following the index PCI. Method of measurement: Major bleeding was defined as clinically overt bleeding causing a decrease in hemoglobin ≥ 3 g/dl requiring transfusion of packed red cells or whole blood, bleedings which require surgical intervention to stop bleeding at the femoral sheath insertion site, intracranial bleeding, and retroperitoneal bleeding. The incidence of minor bleedings. Timepoint: During the first 24 hours following the index PCI. Method of measurement: by observation. The incidence of in-stent acute coronary thrombosis. Timepoint: during 24 hours after PCI. Method of measurement: by Observation. Vice-chanceller for Research Affairs, Shiraz University of Medical Sciences Approved 2008-08-18 Shiraz University of Medical Sciences Zand ave. Shiraz Iran (Islamic Republic of)