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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079586
• Other study ID #: TMC-BIV-02-06
• Secondary ID: EVOLUTION-On
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2004
• Last updated: January 4, 2012
• Start date: April 2004
• Est. completion date: November 2004

Study information

• Verified date: January 2012
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Bypass Surgery

Intervention

Drug:
• Heparin
Unfractionated Heparin per institutional practice
• Bivalirudin
1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Country where clinical trial is conducted

United States,