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Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB
This study is ongoing, but not recruiting participants.
Study NCT00073593   Information provided by The Medicines Company
First Received: November 26, 2003   Last Updated: November 9, 2005   History of Changes

November 26, 2003
November 9, 2005
September 2003
 
 
 
Complete list of historical versions of study NCT00073593 on ClinicalTrials.gov Archive Site
 
 
 
Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB
A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery

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.

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

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
150
February 2004
 

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073593
 
TMC-BIV-02-07, EVOLUTION
The Medicines Company
 
Study Director: Andrew Sternlicht, MD The Medicines Company
The Medicines Company
March 2004

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