Antithrombotic Regimens and Outcome

PROTOCOL SYNOPSIS Title: Comparison of bivalirudin and unfractioned heparin (UFH)+ protamine in elective percutaneous coronary interventions (PCI) Design: Prospective, randomized, controlled trial Hypothesis: Bivalirudin is superior to UFH + protamine for the improvement of outcomes in patients undergoing elective PCI Key Inclusion Criteria: Patients older than 18 years of age to undergo PCI Clopidogrel loading \> 6 hrs prior to PCI according to the PCI guidelines Informed, written consent Key Exclusion Criteria: ST-elevation myocardial infarction within the prior 48 hours Active bleeding, bleeding diathesis, recent surgery Severe renal failure Chronic coronary artery occlusion to be treated Primary endpoint: Inhospital major bleeding Secondary endpoints: 1. Composite rate of death, myocardial infarction (MI) or target vessel revascularization (TVR) inhospital, and at 6 months 2. Composite rate of inhospital death, MI or TVR and major bleeding 3. Major and minor bleedings 4. Total vascular complications 5. Post-procedure renal failure Randomization: Bivalirudin versus unfractioned heparin followed by protamine at the end of the PCI procedure Sample size: Assumed incidence of inhospital major bleeding of 6% in UFH + protamine and of 2% in bivalirudin group; for a power of 80% and a level of 0.05 for each group 425 patients are needed. An interim analysis will be performed after the enrolment of 425 (50%) patients. Follow-up: Inhospital, and 6-month clinical follow-up (out-patient clinic or by phone)