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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00079586
First received: March 9, 2004
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Cardiovascular Disease
Coronary Artery Bypass Surgery
 Drug: Heparin
Drug: Bivalirudin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Medicines Company:

Enrollment: 150
Study Start Date: April 2004
Study Completion Date: November 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00079586     History of Changes
Other Study ID Numbers: TMC-BIV-02-06, EVOLUTION-On
Study First Received: March 9, 2004
Last Updated: January 4, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013