NCT00079586

Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)

A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.

Conditions

• Cardiovascular Disease
• Coronary Artery Bypass Surgery

Interventions

Type	Name	Description
DRUG	Heparin	Unfractionated Heparin per institutional practice
DRUG	Bivalirudin	1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion

Timeline

• Start date: 2004-04-01
• Completion: 2004-11-01
• First posted: 2004-03-11
• Last updated: 2012-01-05

Locations

1 site across 1 country: United States