Fondaparinux as Monotherapy for Deep Vein Thrombosis and/or Pulmonary Embolism (Pilot Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Recurrent acute symptomatic DVT confirmed by venous ultrasound and/or CT scan
Study Overview
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 fondaparinux.
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 tolerate warfarin or to be safely or effectively anticoagulated. Some of the reasons for discontinuing warfarin anticoagulation and switching patients to parenteral anticoagulation are as follows:
- Recurrent venous thromboembolism despite anticoagulation with warfarin
- Clinically important bleeding complications due to warfarin
- Inability to achieve target International Normalized Ratio (INR) on warfarin
- Nonbleeding side effects of warfarin, such as hair loss or rash.
These patients who cannot tolerate or respond adequately to warfarin are usually managed with "off-label" twice-daily enoxaparin injections as monotherapy. The approved duration of treatment of DVT and PE with fondaparinux is 5 to 9 days as a "bridge" to warfarin. Until now, no studies have investigated the use of fondaparinux for more than 26 days for the treatment of PE and more than 10 days for the treatment of DVT.
Treatment doses of twice-daily enoxaparin are only Food and Drug Administration (FDA) approved for 5 to 14 days for "bridging" for the treatment of acute DVT and/or PE patients to warfarin.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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 Criteria
- •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.
- •Known hypersensitivity to fondaparinux
Outcomes
Primary Outcomes
Recurrent acute symptomatic DVT confirmed by venous ultrasound and/or CT scan
Time Frame: 90 Days
Recurrent acute symptomatic PE confirmed by chest CT scan
Time Frame: 90 Days
Major hemorrhage defined as spinal, retroperitoneal or intracranial bleeding, drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding
Time Frame: 90 Days
Secondary Outcomes
- Comparison of Day Zero, 6 week, and Day 90 platelet counts, renal function, hematocrit and transaminase level(90 Days)