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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:
Information provided by (Responsible Party):
Walter Ageno, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00927602
First received: June 24, 2009
Last updated: April 23, 2012
Last verified: April 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • major bleeding [ Time Frame: up to 48 hours from last injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • symptomatic venous thromboembolism [ Time Frame: last treatment dose ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

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
Study First Received: June 24, 2009
Last Updated: April 23, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Renal Insufficiency
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Kidney Diseases
Urologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
 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 May 19, 2013