Safety of Enoxaparin versus unfractioned heparin in patients undergoing percutaneous coronary intervention using drug eluting stents: A pilot study
- Conditions
- Coronary Artery Disease.Chronic ischaemic heart disease
- Registration Number
- IRCT138710101525N1
- Lead Sponsor
- Vice-chanceller for Research Affairs, Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of minor bleedings. Timepoint: During the first 24 hours following the index PCI. Method of measurement: by observation.;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.
- Secondary Outcome Measures
Name Time Method The incidence of in-stent acute coronary thrombosis. Timepoint: during 24 hours after PCI. Method of measurement: by Observation.