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Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB
This study is ongoing, but not recruiting participants.
Sponsored by: The Medicines Company
Information provided by: The Medicines Company
ClinicalTrials.gov Identifier: NCT00073593
  Purpose

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.


Condition Intervention Phase
Cardiac Surgery
Coronary Artery Bypass Surgery
Drug: Angiomax (bivalirudin) anticoagulant
Phase III

MedlinePlus related topics: Blood Thinners Coronary Artery Bypass Surgery
Drug Information available for: Heparin Bivalirudin Protamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery

Further study details as provided by The Medicines Company:

Estimated Enrollment: 150
Study Start Date: September 2003
Estimated Study Completion Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073593

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Medicines Company
Investigators
Study Director: Andrew Sternlicht, MD The Medicines Company
  More Information

Study ID Numbers: TMC-BIV-02-07, EVOLUTION
Study First Received: November 26, 2003
Last Updated: November 9, 2005
ClinicalTrials.gov Identifier: NCT00073593  
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
Off-Pump Coronary Artery Bypass Graft Surgery
CABG
OPCAB
Heparin
Patients requiring off-pump CABG

Study placed in the following topic categories:
Bivalirudin
Protamines
Heparin
Calcium heparin

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009