Status:
COMPLETED
Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)
Lead Sponsor:
The Medicines Company
Conditions:
Cardiovascular Disease
Coronary Artery Bypass Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00079586
Start Date
April 1 2004
End Date
November 1 2004
Last Update
January 5 2012
Active Locations (1)
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1
The Cleveland Clinic
Cleveland, Ohio, United States, 44195