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

The Medicines Company

Status and phase

Completed

Phase 3

Conditions

Coronary Artery Bypass Surgery

Cardiovascular Disease

Treatments

Drug: Heparin

Drug: Bivalirudin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00079586

TMC-BIV-02-06

EVOLUTION-On

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.