Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00413504
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : February 4, 2009
Information provided by:
Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Pulmonary Embolism Drug: Fondaparinux Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fondaparinux as Monotherapy for Deep Vein Thrombosis and/or Pulmonary Embolism (Pilot Study)
Study Start Date : April 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Recurrent acute symptomatic DVT confirmed by venous ultrasound and/or CT scan [ Time Frame: 90 Days ]
  2. Recurrent acute symptomatic PE confirmed by chest CT scan [ Time Frame: 90 Days ]
  3. 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 Outcome Measures :
  1. Comparison of Day Zero, 6 week, and Day 90 platelet counts, renal function, hematocrit and transaminase level [ Time Frame: 90 Days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00413504

Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Layout table for investigator information
Principal Investigator: Samuel Z. Goldhaber, MD Brigham and Women's Hospital

Additional Information:
Layout table for additonal information
Responsible Party: Brigham and Women's Hospital, Venous Thromboembolism Research Group Identifier: NCT00413504    
Other Study ID Numbers: 2006-P-000599
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009
Keywords provided by Brigham and Women's Hospital:
Deep Vein thrombosis
Pulmonary Embolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents