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

Phase 3

Completed

• Conditions: Cardiovascular Disease; Coronary Artery Bypass Surgery
• Interventions: Drug: Heparin; Drug: Bivalirudin

• Registration Number: NCT00079586
• Lead Sponsor: The Medicines Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-03-09
• Study First Submitted QC: 2004-03-10
• Study First Posted: 2004-03-11
• Study Start: 2004-04
• Study Completion: 2004-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin	Heparin	unfractionated heparin will be administered as per institutional practice
Angiomax	Bivalirudin	1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion

Trial Locations

Locations (1)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States