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Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)

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ClinicalTrials.gov Identifier: NCT00079586
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : January 5, 2012
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

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 safe and effective alternative anticoagulant to heparin with protamine reversal.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Coronary Artery Bypass Surgery Drug: Heparin Drug: Bivalirudin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
Study Start Date : April 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Heparin
unfractionated heparin will be administered as per institutional practice
Drug: Heparin
Unfractionated Heparin per institutional practice
Experimental: Angiomax
1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion
Drug: Bivalirudin
1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079586


Locations
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Medicines Company
Investigators
Study Director: Malcolm Lloyd, MD The Medicines Company

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00079586     History of Changes
Other Study ID Numbers: TMC-BIV-02-06
EVOLUTION-On
First Posted: March 11, 2004    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Cardiovascular Diseases
Calcium heparin
Bivalirudin
Heparin
Protamines
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Heparin Antagonists
Coagulants