837
Participants
Start Date
January 31, 2008
Primary Completion Date
December 31, 2012
Study Completion Date
December 31, 2013
Bivalirudin
Patients randomized to Bivalirudin group will be treated by bivalirudin before and during the procedure. Bivalirudin will be given as bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure.The infusion will be lowered to 1.0 mg/kg per hour in patients with eGFR \<30 ml/min/1.73 m2.
Unfractionated Heparin
Patients randomized to the Control group will receive unfractionated heparn (UFH) before and during the procedure. UFH bolus will be of 70 UI/kg. If the activated clotting time measured 5 minutes after the study drug administration is lower than 270 seconds, an additional bolus of the randomised drug (UFH 20 U/kg) will be given.
IRCCS Policlinico Multimedica, Milan
Clinica Mediterranea, Naples
Lead Sponsor
Clinica Mediterranea
OTHER