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

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:

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Fondaparinux Fondaparinux sodium

U.S. FDA Resources

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

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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

Additional 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.

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
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fondaparinux

PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013