Status:
COMPLETED
Antithrombotic Regimens and Outcome
Lead Sponsor:
Careggi Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
PROTOCOL SYNOPSIS Title: Comparison of bivalirudin and unfractioned heparin (UFH)+ protamine in elective percutaneous coronary interventions (PCI) Design: Prospective, randomized, controlled trial H...
Detailed Description
Bivalirudin, a direct thrombin inhibitor, has been recently introduced as an alternative to UFH given several important biologic and pharmacokinetic advantages.1,2 In contrast to UFH, it acts independ...
Eligibility Criteria
Inclusion
- Patients older than age 18 to undergo PCI
- Pretreatment at least 6 hours before PCI with clopidogrel according to the PCI guidelines.
- Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
Exclusion
- Recent ST-elevation myocardial infarction within the last 48 hours.
- Chronic coronary artery occlusion to be treated
- Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance.
- Active bleeding, bleeding diathesis, recent surgery (\< 15 days)
- History of gastrointestinal or genitourinary bleeding within the last 6 weeks
- Treatment with UFH within 6 hours or low-molecular weight heparin within 8 hours before randomization.
- Treatment with bivalirudin within 24 hours beforerandomization.
- Severe uncontrolled hypertension \>180/110 mmHg unresponsive to therapy
- Relevant hematologic deviations: hemoglobin \< 100 g/L OR platelet count \< 100 x 109 /L.
- Glomerular filtration rate (GFR) \< 30 ml/min or serum creatinine \> 30 mg/L or dependence on renal dialysis.
- Known allergy to the study medications: aspirin, clopidogrel, UFH, bivalirudin; stainless steel; true anaphylaxis after prior exposure to contrast media.
- Known heparin-induced thrombocytopenia
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT00448461
Start Date
March 1 2007
End Date
June 1 2008
Last Update
February 10 2009
Active Locations (1)
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1
Division of Cardiology, Careggi Hospital
Florence, Italy, 50141