Status:
COMPLETED
Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Deep Vein Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine whether fondaparinux as monotherapy without warfarin is effective and safe for long-term (90 days) treatment of DVT and/or PE, thus gaining new long-term experience and data using fondapa...
Detailed Description
Background and Significance: Warfarin is usually prescribed to manage long-term anticoagulation of deep vein thrombosis (DVT) and pulmonary embolism (PE). However about 5% of patients are unable to t...
Eligibility Criteria
Inclusion
- Recurrent venous thromboembolism despite anticoagulation with warfarin(Or)
- Clinically important bleeding complications due to warfarin(Or)
- Inability to achieve the target INR on warfarin(Or)
- Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or)
- Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE
- and
- Require at least 90 days of anticoagulation
- Require anticoagulation for objectively confirmed DVT and/or PE
- Age greater than 18 years
- Written informed consent
Exclusion
- Patients with renal insufficiency, defined as creatinine \> 1.5 mg/dl
- Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk.
- Pregnancy
- Known hypersensitivity to fondaparinux
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00413504
Start Date
April 1 2006
End Date
July 1 2007
Last Update
February 4 2009
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115