Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism

Completed · Not applicable

Conditions studied: Deep Vein Thrombosis, Pulmonary Embolism

In brief

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 fondaparinux.

Key facts

Study ID

NCT00413504

Run by

Brigham and Women's Hospital

People needed

30

Starts

2006-04-01

Expected to finish

2007-07-01

Last updated by the study team

2009-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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