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Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency

This study has been terminated.
(study was stopped after enrolment of about 200 patients for slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927602
First Posted: June 25, 2009
Last Update Posted: April 24, 2012
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.
Information provided by (Responsible Party):
Walter Ageno, Università degli Studi dell'Insubria
  Purpose
Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.

Condition Intervention Phase
Medical Patients Renal Insufficiency Drug: fondaparinux Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by Walter Ageno, Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • major bleeding [ Time Frame: up to 48 hours from last injection ]

Secondary Outcome Measures:
  • symptomatic venous thromboembolism [ Time Frame: last treatment dose ]

Enrollment: 206
Study Start Date: April 2009
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fondaparinux Drug: fondaparinux
once daily sc injection, 1,5 mg, max 14 days
Other Name: Arixtra

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 60 years
  • Acute medical disease requiring thromboprophylaxis according to international guidelines
  • Anticipated immobilization of at least 4 days
  • Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min according the MDRD formula
  • Written informed consent

Exclusion Criteria:

  • Active bleeding or bleeding in the previous 3 months
  • Known bleeding diathesis
  • Platelet count < 100.000
  • Ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin K antagonists
  • Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours
  • Life expectancy < 1 month
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00927602


Locations
Italy
University Of Insubria
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Study Chair: Walter Ageno, MD Università degli Studi dell'Insubria
Study Director: Francesco Dentali, MD Università degli Studi dell'Insubria
Principal Investigator: Alessandro Squizzato, MD Università degli Studi dell'Insubria
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Walter Ageno, Associate Professor of Internal Medicine, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT00927602     History of Changes
Other Study ID Numbers: 2008-005234-79
First Submitted: June 24, 2009
First Posted: June 25, 2009
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Walter Ageno, Università degli Studi dell'Insubria:
renal failure
medical patient
venous thromboembolism
prophylaxis
fondaparinux

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Renal Insufficiency
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Fondaparinux
PENTA
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action