Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism - Full Text View

Sponsors and Collaborators:	Brigham and Women's Hospital GlaxoSmithKline
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00413504

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

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Fondaparinux sodium ORG 31540

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Fondaparinux as Monotherapy for Deep Vein Thrombosis and/or Pulmonary Embolism (Pilot Study)

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:

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

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.
Pregnancy
Known hypersensitivity to fondaparinux

Contacts and Locations

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

North American Thrombosis Forum This link exits the ClinicalTrials.gov site

Publications:

Petitou M, Duchaussoy P, Herbert JM, Duc G, El Hajji M, Branellec JF, Donat F, Necciari J, Cariou R, Bouthier J, Garrigou E. The synthetic pentasaccharide fondaparinux: first in the class of antithrombotic agents that selectively inhibit coagulation factor Xa. Semin Thromb Hemost. 2002 Aug;28(4):393-402. Review.

Buller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, van den Berg-Segers AE, Cariou R, Leeuwenkamp O, Lensing AW; Matisse Investigators. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med. 2003 Oct 30;349(18):1695-702. Erratum in: N Engl J Med. 2004 Jan 22;350(4):423.

Buller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, Segers AE, Cariou R, Leeuwenkamp O, Lensing AW; Matisse Investigators. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med. 2004 Jun 1;140(11):867-73.

Study ID Numbers:	2006-P-000599
Study First Received:	December 7, 2006
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00413504
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

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases

Vascular Diseases
Fondaparinux
Venous Thrombosis
Org 31540
Thrombosis

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009