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Home > "C" Clinical Trials Conditions > Comparing Angiomax to Heparin with Protamine Reversal in Patients OPCAB  Comparing Angiomax to Heparin with Protamine Reversal in Patients OPCAB
Comparing Angiomax to Heparin with Protamine Reversal in Patients OPCAB
For Condition: Cardiac Surgery,Coronary Artery Bypass Surgery
Status: No longer recruiting
Sponsor(s): The Medicines Company ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
AndrewSternlicht, Study Director, The Medicines Company
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Additional Information:
Study ID Numbers: TMC-BIV-02-07; EVOLUTION
Study Start Date: September 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073593
Other Cardiac Surgery Studies:
1. Comparing Angiomax to Heparin with Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)
2. Angiomax in Patients with HIT/HITTS Type II Undergoing CPB
3. Comparing Angiomax to Heparin with Protamine Reversal in Patients OPCAB
Related Studies:
Other Cardiac Surgery Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Comparing Angiomax to Heparin with Protamine Reversal in Patients OPCAB
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