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.

Condition	Treatment or Intervention	Phase
Cardiac Surgery Coronary Artery Bypass Surgery	Drug: Angiomax (bivalirudin) anticoagulant	Phase III

Further Study Details: 

Expected Total Enrollment:  150

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion:

• 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

Exclusion:

• Any prior Cardio-Thoracic Surgical procedures requiring median sternotomy
• Confirmed pregnancy – baseline urine or serum pregnancy test (if woman of childbearing potential).
• 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 glyoprotein IIb/IIIa inhibitor within 48 hours if abciximab (ReoPro) or within 24 hours if eptifibatide (Integrilin) and tirofiban (Aggrastat) of randomization
• Patients receiving lepirudin or argatroban within the previous 24 hours of randomization.
• 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.

Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States

Study chairs or principal investigators

Andrew Sternlicht, MD,  Study Director,  The Medicines Company   

Study ID Numbers:  TMC-BIV-02-07; EVOLUTION
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 26, 2003
ClinicalTrials.gov Identifier:  NCT00073593
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08