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Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)
This study has been completed.
Study NCT00079586   Information provided by The Medicines Company
First Received: March 9, 2004   Last Updated: March 16, 2006   History of Changes

March 9, 2004
March 16, 2006
April 2004
 
 
 
Complete list of historical versions of study NCT00079586 on ClinicalTrials.gov Archive Site
 
 
 
Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)
A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)

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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Cardiovascular Disease
  • Coronary Artery Bypass Surgery
Drug: Angiomax (bivalirudin)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
150
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00079586
 
TMC-BIV-02-06, EVOLUTION-On
The Medicines Company
 
Study Director: Malcolm Lloyd, MD The Medicines Company
The Medicines Company
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP