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Angiomax in Patients With HIT/HITTS Type II Undergoing CPB

This study is ongoing, but not recruiting participants.

Sponsored by: The Medicines Company
Information provided by: The Medicines Company
ClinicalTrials.gov Identifier: NCT00079508
  Purpose

The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and effective anticoagulant.


Condition Intervention Phase
Cardiovascular Disease
Coronary Artery Bypass Surgery
Drug: Angiomax (bivalirudin)
Phase III

ChemIDplus related topics:   Heparin    Bivalirudin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase III Study of Angiomax (Bivalirudin) in Patients With HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)

Further study details as provided by The Medicines Company:

Estimated Enrollment:   50
Study Start Date:   April 2004

Detailed Description:

An open-label, prospective, multicenter, single-arm study; with a historical reference cohort of similarly identified HIT/HITTS patients from participating institutions that underwent cardiac surgery on CPB with alternative anticoagulation regimens during the period of approximately 12 months prior to initiation of the first patient into this study.

  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, and
  • Be at least 18 years of age, and
  • Be scheduled for CABG, CABG single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eligible for this study, and demonstrated
  • New diagnosis or history of objectively documented HIT/HITTS Type II, defined as one or more of the following:

    1. Positive heparin-induced platelet aggregation (HIPA) or other functional assay for HIT or immunoassay for HIT antibodies (ELISA), AND/OR
    2. HIT: Thrombocytopenia associated with heparin therapy, where the platelet count has decreased by 50%*, OR
    3. HITTS: Thrombocytopenia (as defined in B above) PLUS any evidence of arterial or venous thrombosis

Exclusion Criteria

  • Confirmed pregnancy at time of enrollment 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 <30mL/min.
  • Ongoing treatment with warfarin (or other oral anticoagulant) at the time of enrollment.

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 may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with recent clopidogrel administration.
  • Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours prior to enrollment if abciximab (ReoPro®) or 12 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®), may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with not waiting the 48 or 12 hour time period prior to enrollment.
  • Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to enrollment.

Patients currently receiving lepirudin or argatroban can be enrolled if they are switched to Angiomax at least 24 hours prior to the planned cardiac surgery.

  • Patients receiving LMWH or thrombolytics within the previous 12 hours may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with not waiting the 12 hour time period.
  • Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
  • 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: NCT00079508

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


Study ID Numbers:   TMC-BIV-02-03, CHOOSE-On
First Received:   March 9, 2004
Last Updated:   March 16, 2006
ClinicalTrials.gov Identifier:   NCT00079508
Health Authority:   United States: Food and Drug Administration

Keywords provided by The Medicines Company:
Heparin-induced Thrombocytopenia  
Heparin-induced Thrombocytopenia/Thrombosis Syndrome  
HIT/HITTS  
Heparin anti-body positive  

Study placed in the following topic categories:
Antibodies
Thrombocytopenia
Heparin-induced thrombocytopenia
Bivalirudin
Heparin
Thrombosis
Calcium heparin

Additional relevant MeSH terms:
Anticoagulants
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




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