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)