Status:
COMPLETED
Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB
Lead Sponsor:
The Medicines Company
Conditions:
Cardiac Surgery
Coronary Artery Bypass Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 gr...
Eligibility Criteria
Inclusion
- 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 glycoprotein 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.
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00073593
Start Date
August 1 2003
Last Update
November 10 2011
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195