Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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 fondaparinux.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: GlaxoSmithKline
• Treatments: Fondaparinux; PENTA

Criteria

Inclusion Criteria:

1. Recurrent venous thromboembolism despite anticoagulation with warfarin(Or)

2. Clinically important bleeding complications due to warfarin(Or)

3. Inability to achieve the target INR on warfarin(Or)

4. Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or)

5. Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE

and

6. Require at least 90 days of anticoagulation

7. Require anticoagulation for objectively confirmed DVT and/or PE

8. Age greater than 18 years

9. Written informed consent

Exclusion Criteria:

1. Patients with renal insufficiency, defined as creatinine > 1.5 mg/dl

2. Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk.

3. Pregnancy

4. Known hypersensitivity to fondaparinux