NCT00073593

Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.

Conditions

• Cardiac Surgery
• Coronary Artery Bypass Surgery

Interventions

Type	Name	Description
DRUG	Bivalirudin	250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) \>300 seconds (s).
DRUG	Heparin	: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of \>300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock.
DRUG	Protamine	Per institutional practice. Batches from hospital stock.

Timeline

• Start date: 2003-08-01
• Primary completion: 2004-05-01
• First posted: 2003-11-27
• Last updated: 2011-11-10

Locations

1 site across 1 country: United States