Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00413504
First received: December 7, 2006
Last updated: February 2, 2009
Last verified: February 2009
  Purpose

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 Intervention
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Fondaparinux

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fondaparinux as Monotherapy for Deep Vein Thrombosis and/or Pulmonary Embolism (Pilot Study)

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Comparison of Day Zero, 6 week, and Day 90 platelet counts, renal function, hematocrit and transaminase level [ Time Frame: 90 Days ]

Enrollment: 30
Study Start Date: April 2006
Study Completion Date: July 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413504

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Samuel Z. Goldhaber, MD Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Brigham and Women's Hospital, Venous Thromboembolism Research Group
ClinicalTrials.gov Identifier: NCT00413504     History of Changes
Other Study ID Numbers: 2006-P-000599
Study First Received: December 7, 2006
Last Updated: February 2, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Fondaparinux
Monotherapy
Deep Vein thrombosis
Pulmonary Embolism
Anticoagulation

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Fondaparinux
PENTA
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014