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)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Coronary Artery Bypass Surgery
• Intervention / Treatment: Drug: Heparin; Drug: Bivalirudin

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Provide written informed consent before initiation of any study related procedures.
• Be at least 18 years of age.
• Be scheduled for CABG, CABG and single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eligible for this study.

Exclusion Criteria

• Confirmed pregnancy at time of randomization via IVRS (if woman of child-bearing potential) (Urine or serum pregnancy test)
• Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
• Intracranial neoplasm, arteriovenous malformation or aneurysm.
• Dependency on renal dialysis or creatinine clearance <30 mL/min.
• Ongoing treatment with warfarin (or other oral anticoagulant) at the time of randomization.

Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is < 1.3 times control in the absence of heparin therapy.

• Known allergy to Angiomax or hirudin-derived drugs, or known sensitivity to any component of the product.
• Patients receiving clopidogrel (Plavix®) within the previous 5 days of randomization
• Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours if abciximab (ReoPro®) or 24 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®) of randomization.
• Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to randomization.
• Patients receiving LMWH or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.
• Refusal to undergo blood transfusion should it become necessary.
• Any other disease or condition, which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
• Planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts.
• Planned (>1) double (or greater) valve repair-replacement (e.g.: AVR-MVR) surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Heparin; unfractionated heparin will be administered as per institutional practice	Drug: Heparin; Unfractionated Heparin per institutional practice
Experimental: Angiomax; 1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion	Drug: Bivalirudin; 1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion

Collaborators and Investigators

• Sponsor: The Medicines Company
• Investigators: Study Director: Malcolm Lloyd, MD, The Medicines Company

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: March 9, 2004
• First Submitted That Met QC Criteria: March 10, 2004
• First Posted (Estimate): March 11, 2004

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 4, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin
• Other Study ID Numbers: TMC-BIV-02-06; EVOLUTION-On