A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
Heparin
+ Bivalirudin
Cardiovascular Diseases
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.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 safe and effective alternative anticoagulant to heparin with protamine reversal.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location