The purpose of this study is to examine the safety and efficacy of Angiomax as an
alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump
coronary artery bypass graft surgery.
- Provide written informed consent before initiation of any study related procedures.
- Be at least 18 years of age.
- Be accepted for elective off-pump coronary artery bypass graft (CABG) surgery without
concomitant cardiac surgical procedures.
- < 4 planned Coronary Artery Bypass Grafts
- Any prior Cardio-Thoracic Surgical procedures requiring median sternotomy
- Confirmed pregnancy - baseline urine or serum pregnancy test (if woman of
- Cerebrovascular accident within 6 months before randomization, or any cerebrovascular
accident with residual neurological deficit.
- Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- Dependency on renal dialysis or creatinine clearance <30mL/min.
- Ongoing treatment with warfarin (or other oral anticoagulants) 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 these products.
- Patients receiving clopidogrel within the previous 5 days of randomization.
- Patients receiving a glycoprotein IIb/IIIa inhibitor within 48 hours if abciximab
(ReoPro) or within 24 hours if eptifibatide (Integrilin) and tirofiban (Aggrastat) of
- Patients receiving lepirudin or argatroban within the previous 24 hours of
- Patients receiving low molecular weight heparin (LMWH) or thrombolytics within the
previous 12 hours or unfractionated heparin within 30 minutes of randomization.
- Patients with active or prior history of heparin-induced thrombocytopenia
(HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS)*.
- 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 inability to comply
with study requirements.