Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

837

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2013

Conditions
Bleeding
Interventions
DRUG

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.

DRUG

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.

Trial Locations (2)

20142

IRCCS Policlinico Multimedica, Milan

80121

Clinica Mediterranea, Naples

Sponsors
All Listed Sponsors
lead

Clinica Mediterranea

OTHER

NCT01465503 - Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients | Biotech Hunter | Biotech Hunter